{ "id": "tessalon-benzonatate", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-31", "status": "published_traceable_archive" }, "names": { "brand": "TESSALON", "generic": "苯佐那酯", "aliases": [ "Tessalon", "benzonatate", "苯佐那酯", "苯佐那酯胶囊", "benzonatate capsules", "TESSALON", "NDA 011210", "64380-712-06", "64380-712-07", "64380-713-06", "64380-713-07" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "呼吸系统", "sourceArchiveMarket": "美国 FDA Orange Book 将 TESSALON 与 NDA 011210 相连：100 mg 产品 001 为 RLD 的 RX 行，200 mg 产品 003 为历史 RLD、当前 DISCN。当前用药安全内容采用 2026-06 DailyMed 通用药标签；历史品牌标签只用于解释 TESSALON 名称、机制与安全标签沿革，不能冒充当前品牌包装或实时供应。", "dosageFormClass": "苯佐那酯口服液体填充胶囊：100 mg 或 200 mg 均为每粒含量。胶囊必须整粒吞服，不得掰开、咀嚼、溶解、切开或压碎；网页不把 mg、瓶装粒数或历史品牌规格换算成个人用法。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1958（美国品牌初始批准年份）", "archiveSponsorText": "Pfizer（美国历史品牌 NDA 记录）；当前公开包装来自通用药标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "TESSALON benzonatate", "benzonatate capsules", "苯佐那酯", "苯佐那酯胶囊" ], "excludedProductCues": [ "dextromethorphan", "右美沙芬", "codeine cough syrup", "可待因止咳糖浆", "benzonatate compounded liquid", "苯佐那酯口服液" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-generic-benzonatate-100mg-6438071206", "marketCode": "US", "labelVersion": { "zh": "2026-06 当前美国通用药标签", "en": "Current U.S. generic label revised June 2026" }, "dosageForm": { "zh": "苯佐那酯 100 mg 口服液体填充胶囊", "en": "Benzonatate 100 mg oral liquid-filled capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 64380-712-06", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒含苯佐那酯 100 mg；100 粒瓶装；mg 是每粒强度，不是个人粒数或频率", "en": "100 mg benzonatate per capsule; 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500-capsule bottle; mg is strength per capsule, not an individual's capsule count or frequency" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "苯佐那酯", "en": "benzonatate" }, "value": 100, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不得从该数字生成个人用法", "en": "labelled amount per capsule; must not generate individual use from this figure" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 500, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_generic_label_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 500, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_8862dd9659d90442", "label": "DailyMed（NLM）：苯佐那酯 100 mg、200 mg 口服胶囊当前美国通用药标签（2026-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89f5d18e-5ef4-42a3-bc6f-abf4f308462b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-benzonatate-200mg-6438071306", "marketCode": "US", "labelVersion": { "zh": "2026-06 当前美国通用药标签", "en": "Current U.S. generic label revised June 2026" }, "dosageForm": { "zh": "苯佐那酯 200 mg 口服液体填充胶囊", "en": "Benzonatate 200 mg oral liquid-filled capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 64380-713-06", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒含苯佐那酯 200 mg；100 粒瓶装；mg 是每粒强度，不是个人粒数或频率", "en": "200 mg benzonatate per capsule; 100-capsule bottle; mg is strength per capsule, not an individual's capsule count or frequency" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "苯佐那酯", "en": "benzonatate" }, "value": 200, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不得从该数字生成个人用法", "en": "labelled amount per capsule; must not generate individual use from this figure" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_generic_label_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_8862dd9659d90442", "label": "DailyMed（NLM）：苯佐那酯 100 mg、200 mg 口服胶囊当前美国通用药标签（2026-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89f5d18e-5ef4-42a3-bc6f-abf4f308462b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-benzonatate-200mg-6438071307", "marketCode": "US", "labelVersion": { "zh": "2026-06 当前美国通用药标签", "en": "Current U.S. generic label revised June 2026" }, "dosageForm": { "zh": "苯佐那酯 200 mg 口服液体填充胶囊", "en": "Benzonatate 200 mg oral liquid-filled capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 64380-713-07", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒含苯佐那酯 200 mg；500 粒瓶装；mg 是每粒强度，不是个人粒数或频率", "en": "200 mg benzonatate per capsule; 500-capsule bottle; mg is strength per capsule, not an individual's capsule count or frequency" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "苯佐那酯", "en": "benzonatate" }, "value": 200, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不得从该数字生成个人用法", "en": "labelled amount per capsule; must not generate individual use from this figure" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 500, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_generic_label_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 500, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_8862dd9659d90442", "label": "DailyMed（NLM）：苯佐那酯 100 mg、200 mg 口服胶囊当前美国通用药标签（2026-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89f5d18e-5ef4-42a3-bc6f-abf4f308462b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-historic-tessalon-100mg-product-001", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前数据集中的历史品牌记录", "en": "Historical brand record in the current FDA Orange Book dataset" }, "dosageForm": { "zh": "TESSALON 苯佐那酯 100 mg 口服胶囊", "en": "TESSALON benzonatate 100 mg oral capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDA 011210 / Product 001", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "历史品牌每粒 100 mg；Orange Book 当前为 RX 行", "en": "Historical brand 100 mg per capsule; currently an RX row in the Orange Book" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "苯佐那酯", "en": "benzonatate" }, "value": 100, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒历史品牌标示量；不证明当前品牌库存", "en": "amount per historical brand capsule; does not establish current brand stock" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "orange_book_rx_historical_brand_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：TESSALON／benzonatate NDA 011210 品牌参比记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-historic-tessalon-200mg-product-003", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前数据集中的历史品牌记录", "en": "Historical brand record in the current FDA Orange Book dataset" }, "dosageForm": { "zh": "TESSALON 苯佐那酯 200 mg 口服胶囊", "en": "TESSALON benzonatate 200 mg oral capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDA 011210 / Product 003", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "历史品牌每粒 200 mg；当前 DISCN", "en": "Historical brand 200 mg per capsule; currently DISCN" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "苯佐那酯", "en": "benzonatate" }, "value": 200, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒历史品牌标示量；不证明当前品牌库存", "en": "amount per historical brand capsule; does not establish current brand stock" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：TESSALON／benzonatate NDA 011210 品牌参比记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "当前通用药标签有胶囊外观文字，但未把通用药外观冒充为 TESSALON 品牌包装", "en": "The current generic label has capsule appearance text, but generic appearance is not presented as a TESSALON brand pack" }, "summary": { "zh": "当前标签描述 100 mg 和 200 mg 为黄色椭圆软胶囊，但不同厂商、批次或市场外观可能不同。本站暂不展示未能与六个身份逐一对应的包装主图；颜色、形状或透明液体都不能单独确认真伪。", "en": "The current label describes yellow oval soft-gelatin capsules for 100 mg and 200 mg, but appearance can differ by manufacturer, batch or market. The site does not show a pack image that cannot be matched one-to-one to all six identities; colour, shape or visible liquid alone cannot establish authenticity." }, "source": { "id": "src_8862dd9659d90442", "label": "DailyMed（NLM）：苯佐那酯 100 mg、200 mg 口服胶囊当前美国通用药标签（2026-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89f5d18e-5ef4-42a3-bc6f-abf4f308462b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "苯佐那酯说明书放大阅读：整粒吞服、口咽麻木、儿童误服与过量急救", "en": "Benzonatate enlarged label: swallow whole, oral numbness, child ingestion and overdose emergency" }, "summary": { "zh": "100 mg、200 mg 是每粒强度，不是一次粒数。当前标签要求整粒吞服；任何儿童误服、疑似多服，或出现抽搐、昏迷、呼吸/心脏异常，都需要立即使用当地急救或毒物咨询渠道，并带上药盒。", "en": "100 mg and 200 mg are strengths per capsule, not a capsule count per dose. The current label requires swallowing the capsule whole. Any child ingestion, suspected extra ingestion, seizure, coma, breathing problem or cardiac problem requires immediate local emergency or poison-centre help with the pack." }, "checks": [ { "zh": "胶囊不得掰开、咀嚼、溶解、切开或压碎。内容物在口腔释放可造成暂时性口腔/咽喉麻木并引发呛噎；吞咽困难时不要自行改成液体、挤出或混食物，应让药师核对可用替代方案。", "en": "Do not break, chew, dissolve, cut or crush the capsule. Release in the mouth can cause temporary oral or throat anaesthesia and choking. For swallowing difficulty, do not self-convert it to a liquid, squeeze it out or mix it with food; ask a pharmacist to review an available alternative." }, { "zh": "若舌、口、咽喉或面部麻木/刺痛，不要继续进食或饮水直到麻木消退，以降低呛噎风险；症状加重、持续或伴呼吸困难，应立即就医。", "en": "If the tongue, mouth, throat or face becomes numb or tingles, avoid food and liquids until the numbness resolves to reduce choking risk. Worsening, persistent symptoms or breathing difficulty requires immediate medical care." }, { "zh": "儿童误服曾导致死亡，过量症状可在 15–20 分钟内出现，死亡可在一小时内发生。任何儿童误服或疑似过量都不要观察等待，应立即联系当地急救或毒物咨询。", "en": "Accidental child ingestion has caused death. Overdose features can begin within 15–20 minutes and death has been reported within one hour. Do not watch and wait after any child ingestion or suspected overdose; immediately contact local emergency or poison services." }, { "zh": "老年人、吞咽困难者、多药并用者，或既往对普鲁卡因、丁卡因等对氨基苯甲酸类局麻药有反应者，应带完整药单和准确药盒核对。网页不根据年龄、咳嗽或 mg 自动生成个人方案。", "en": "Older adults, people with dysphagia or several medicines, and those with prior reactions to para-aminobenzoic-acid local anaesthetics such as procaine or tetracaine should review the exact pack and full medicine list. The site does not generate an individual plan from age, cough or milligrams." } ], "source": { "id": "src_8862dd9659d90442", "label": "DailyMed（NLM）：苯佐那酯 100 mg、200 mg 口服胶囊当前美国通用药标签（2026-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89f5d18e-5ef4-42a3-bc6f-abf4f308462b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "苯佐那酯怎样减轻咳嗽：外周麻醉牵张感受器，不等于治疗咳嗽病因", "en": "How benzonatate reduces cough: peripheral anaesthesia of stretch receptors does not treat the cause" }, "summary": { "zh": "FDA 历史品牌标签描述其在呼吸道、肺和胸膜的牵张感受器处发挥外周麻醉作用，从而减弱咳嗽反射。机制只解释止咳路径，不能判断咳嗽是否由感染、哮喘、心脏问题、药物或其他原因引起。", "en": "The historical FDA brand label describes peripheral anaesthesia of stretch receptors in the respiratory passages, lungs and pleura, dampening the cough reflex. This mechanism explains the antitussive pathway only; it cannot determine whether a cough is due to infection, asthma, a cardiac problem, a medicine or another cause." }, "checks": [ { "zh": "这是处方止咳药档案，不是抗菌药，也不治疗所有咳嗽病因。呼吸困难、胸痛、咯血、发绀、意识改变或快速恶化应立即求助当地急救。", "en": "This is a prescription antitussive dossier, not an antibacterial, and it does not treat every cause of cough. Breathing difficulty, chest pain, coughing blood, cyanosis, altered awareness or rapid deterioration requires immediate local emergency help." }, { "zh": "与右美沙芬、可待因、抗组胺药或其他止咳感冒药用途相近，不表示可以按 mg 自行换算、叠加或轮换；先核对全部有效成分和完整药单。", "en": "A similar purpose to dextromethorphan, codeine, an antihistamine or another cough/cold product does not permit self-conversion, combination or rotation by milligrams. Check every active ingredient and the complete medicine list first." }, { "zh": "历史品牌标签描述的起效与持续时间是群体标签信息，不是网页用来判断某个人何时补服、加量或追加另一种止咳药的时钟。若咳嗽未缓解或反复，应核对病因和准确处方。", "en": "The onset and duration described in the historical brand label are population-level label information, not a clock for this site to decide when an individual should make up, increase or add another cough medicine. Persistent or recurrent cough requires review of the cause and exact prescription." } ], "source": { "id": "src_650d96939b67ceef", "label": "FDA：TESSALON NDA 011210/S-053 历史品牌标签（2011；不是当前标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011210s053lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_historical_record", "documentKind": "historical_product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "TESSALON", "generic": "苯佐那酯", "dosageFormClass": "苯佐那酯口服液体填充胶囊：100 mg 或 200 mg 均为每粒含量。胶囊必须整粒吞服，不得掰开、咀嚼、溶解、切开或压碎；网页不把 mg、瓶装粒数或历史品牌规格换算成个人用法。" }, "labelSource": { "id": "src_8862dd9659d90442", "label": "DailyMed（NLM）：苯佐那酯 100 mg、200 mg 口服胶囊当前美国通用药标签（2026-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89f5d18e-5ef4-42a3-bc6f-abf4f308462b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "productRoutes": [ { "source": { "id": "src_8862dd9659d90442", "label": "DailyMed（NLM）：苯佐那酯 100 mg、200 mg 口服胶囊当前美国通用药标签（2026-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89f5d18e-5ef4-42a3-bc6f-abf4f308462b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-31", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：TESSALON／benzonatate NDA 011210 品牌参比记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-31", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "TESSALON 是苯佐那酯的美国历史品牌档案。最重要的安全识别不是颜色，而是准确成分和完整胶囊：咀嚼或释放胶囊内容物可造成口咽麻木与呛噎；儿童误服或任何疑似过量都可能迅速危及生命，应立即联系当地急救或毒物咨询，不等待症状出现。", "history": "FDA 历史标签将 TESSALON 的美国初始批准年份列为 1958。200 mg 品牌规格于 1999-06-25 获批；2011 年 FDA 批准因儿童误服和过量风险而更新的安全标签。当前页面把历史品牌证据和 2026 年通用药标签明确分开。", "sourceDocuments": [ { "id": "src_8862dd9659d90442", "label": "DailyMed（NLM）：苯佐那酯 100 mg、200 mg 口服胶囊当前美国通用药标签（2026-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89f5d18e-5ef4-42a3-bc6f-abf4f308462b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, { "id": "src_650d96939b67ceef", "label": "FDA：TESSALON NDA 011210/S-053 历史品牌标签（2011；不是当前标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011210s053lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_historical_record", "documentKind": "historical_product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, { "id": "src_758274046c04b250", "label": "FDA：TESSALON NDA 011210/S-053 儿童误服与过量安全标签补充批准信（2011）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/011210s053ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_historical_record", "documentKind": "regulatory_decision_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：TESSALON／benzonatate NDA 011210 品牌参比记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 011210（TESSALON / benzonatate oral capsules）", "approvalTimeline": [ { "date": "1958-01-01", "title": { "zh": "美国初始批准年份", "en": "Initial U.S. approval year" }, "detail": { "zh": "FDA 历史标签列 Initial U.S. Approval: 1958；这里只记录年份，不推定具体日期、包装或当前库存。", "en": "The historical FDA label states Initial U.S. Approval: 1958. This records the year only and does not infer an exact date, pack or current stock." }, "source": { "id": "src_650d96939b67ceef", "label": "FDA：TESSALON NDA 011210/S-053 历史品牌标签（2011；不是当前标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011210s053lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_historical_record", "documentKind": "historical_product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } }, { "date": "1999-06-25", "title": { "zh": "TESSALON 200 mg 品牌规格获批", "en": "TESSALON 200 mg brand strength approved" }, "detail": { "zh": "Orange Book 将产品 003、200 mg 与 NDA 011210 相连；当前为 DISCN，且公开数据说明并非因安全性或有效性撤回。", "en": "The Orange Book links Product 003, 200 mg, to NDA 011210. It is currently DISCN, with public data indicating no withdrawal for safety or effectiveness." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：TESSALON／benzonatate NDA 011210 品牌参比记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2011-02-10", "title": { "zh": "FDA 批准儿童误服与过量安全标签更新", "en": "FDA approved child-ingestion and overdose safety labelling" }, "detail": { "zh": "NDA 011210/S-053 补充批准信记录与儿童误服、过量和中毒风险有关的标签修订。", "en": "The NDA 011210/S-053 approval letter records labelling revisions addressing accidental child ingestion, overdose and poisoning risk." }, "source": { "id": "src_758274046c04b250", "label": "FDA：TESSALON NDA 011210/S-053 儿童误服与过量安全标签补充批准信（2011）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/011210s053ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_historical_record", "documentKind": "regulatory_decision_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } }, { "date": "2026-06-01", "title": { "zh": "当前通用药标签修订", "en": "Current generic label revision" }, "detail": { "zh": "DailyMed 当前页面列出 2026-06 修订的苯佐那酯胶囊标签；该文件用于当前安全阅读，不证明历史品牌当前有货。", "en": "The current DailyMed page lists a benzonatate capsule label revised June 2026. It supports current safety reading and does not establish current stock of the historical brand." }, "source": { "id": "src_8862dd9659d90442", "label": "DailyMed（NLM）：苯佐那酯 100 mg、200 mg 口服胶囊当前美国通用药标签（2026-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89f5d18e-5ef4-42a3-bc6f-abf4f308462b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "历史品牌参比记录与当前通用药标签并列", "en": "Historical brand reference record and current generic label shown separately" }, "detail": { "zh": "TESSALON 100 mg 的 Orange Book 行仍为 RX，200 mg 行为 DISCN；当前展示的四个 NDC 是通用药包装，不冒充品牌。", "en": "The TESSALON 100 mg Orange Book row remains RX, while the 200 mg row is DISCN. The four current NDCs shown are generic packs and are not presented as brand packs." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国 NDA、商品名或通用名推定当地批准、商品名、供应、处方资格、原研/仿制关系或可替代性。", "en": "No local approval, trade name, supply, prescription status, originator/generic relationship or interchangeability is inferred from the U.S. NDA, brand or generic name." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "100 mg 胶囊可以咬开或挤一半，变成 50 mg 吗？", "en": "Can a 100 mg capsule be bitten or half squeezed out to make 50 mg?" }, "answer": { "zh": "不可以。标签明确要求完整吞服，禁止掰开、咀嚼、溶解、切开或压碎；释放内容物可造成口咽麻木和呛噎。需要不同方案时应让药师或开方者核对准确替代产品。", "en": "No. The label requires swallowing whole and says not to break, chew, dissolve, cut or crush it. Released contents can cause oral/throat anaesthesia and choking. Ask a pharmacist or prescriber to review an exact alternative product if a different plan is needed." } }, { "question": { "zh": "孩子可能误吞了一粒，但现在没有症状，可以先观察吗？", "en": "A child may have swallowed one capsule but has no symptoms. Can we watch first?" }, "answer": { "zh": "不要等待症状。儿童误服可能迅速危及生命，应立即联系当地急救或毒物咨询，并带上准确药盒；网页不能远程排除风险。", "en": "Do not wait for symptoms. Accidental child ingestion can become life-threatening rapidly. Immediately contact local emergency or poison services and take the exact pack; a webpage cannot rule out risk remotely." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label", "dose-unit-literacy" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/tessalon-benzonatate/", "en": "https://origindrug.com/en/drugs/tessalon-benzonatate/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }