{ "id": "clarinex-desloratadine", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-03", "status": "published_traceable_archive" }, "names": { "brand": "CLARINEX", "generic": "地氯雷他定片", "aliases": [ "Clarinex", "desloratadine", "desloratadine tablets", "地氯雷他定", "地氯雷他定片", "CLARINEX", "NDA 021165", "78206-119-01", "78206-188-01", "C5", "SP" ], "marketBrandNames": [ { "name": "CLARINEX", "market": { "zh": "美国处方品牌", "en": "U.S. prescription brand" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "NDA 021165；当前公开包装为 5 mg 普通片、100 片瓶装。", "en": "NDA 021165; current public packs are 5 mg immediate-release tablets in 100-tablet bottles." }, "source": { "id": "src_b01f54336fd75a97", "label": "DailyMed（NLM）：CLARINEX 地氯雷他定 5 mg 薄膜衣片当前美国处方标签（SPL v6，2025-05-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c671342e-69a2-4ca5-abc2-8166ed4240d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "呼吸系统", "sourceArchiveMarket": "当前 DailyMed 标签显示美国 CLARINEX 5 mg 普通薄膜衣片，两个 NDC 均为 100 片瓶装；同一标签明确说明 CLARINEX 品牌口服液和 RediTabs 口崩片已不再销售。其他厂家地氯雷他定、CLARINEX-D 复方缓释片以及其他国家的批准、供应和法律分类必须另查当地记录。", "dosageFormClass": "普通薄膜衣口服片。5 mg 表示每片含有的地氯雷他定量，100 表示每瓶片数；两个数字不能相乘或直接变成个人每天吃几片。口服液浓度、口崩片和含伪麻黄碱的 CLARINEX-D 是不同产品身份，不能混算。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2001（美国 NDA 021165 首次批准）", "archiveSponsorText": "Schering-Plough/Merck（研发与批准历史）；Organon LLC（当前美国公开标签）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "CLARINEX desloratadine", "CLARINEX 地氯雷他定片" ], "excludedProductCues": [ "CLARINEX-D", "CLARINEX-D 12 HOUR", "desloratadine pseudoephedrine", "CLARITIN", "loratadine", "氯雷他定", "XYZAL", "levocetirizine", "ZYRTEC", "cetirizine" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-clarinex-desloratadine-tablet-5mg-100-bottle-ndc-78206-119-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国处方品牌标签（SPL v6，2025-05-28 发布）", "en": "Current U.S. prescription brand label (SPL v6, published 28 May 2025)" }, "dosageForm": { "zh": "CLARINEX 地氯雷他定普通薄膜衣片", "en": "CLARINEX desloratadine immediate-release film-coated tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-119-01", "pouchCode": null, "applicationNumber": "NDA 021165", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片地氯雷他定 5 mg；100 片高密度聚乙烯瓶装", "en": "Desloratadine 5 mg per tablet; 100-tablet high-density polyethylene bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=clarinex-02.jpg&setid=c671342e-69a2-4ca5-abc2-8166ed4240d4&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "地氯雷他定", "en": "desloratadine" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是任何人的片数、频率或疗程", "en": "labelled amount per tablet; not an individual's tablet count, frequency or course" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "高密度聚乙烯瓶", "en": "high-density polyethylene bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-03", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅蓝色", "en": "light blue" }, "shape": { "zh": "圆形薄膜衣片，无刻痕", "en": "round film-coated tablet, not scored" }, "imprint": { "zh": "C5", "en": "C5" }, "scoreStatus": "not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_b01f54336fd75a97", "label": "DailyMed（NLM）：CLARINEX 地氯雷他定 5 mg 薄膜衣片当前美国处方标签（SPL v6，2025-05-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c671342e-69a2-4ca5-abc2-8166ed4240d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-clarinex-desloratadine-tablet-5mg-100-bottle-ndc-78206-188-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国处方品牌标签（SPL v6，2025-05-28 发布）", "en": "Current U.S. prescription brand label (SPL v6, published 28 May 2025)" }, "dosageForm": { "zh": "CLARINEX 地氯雷他定普通薄膜衣片", "en": "CLARINEX desloratadine immediate-release film-coated tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-188-01", "pouchCode": null, "applicationNumber": "NDA 021165", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片地氯雷他定 5 mg；100 片高密度聚乙烯瓶装", "en": "Desloratadine 5 mg per tablet; 100-tablet high-density polyethylene bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=clarinex-03.jpg&setid=c671342e-69a2-4ca5-abc2-8166ed4240d4&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "地氯雷他定", "en": "desloratadine" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是任何人的片数、频率或疗程", "en": "labelled amount per tablet; not an individual's tablet count, frequency or course" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "高密度聚乙烯瓶", "en": "high-density polyethylene bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-03", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅蓝色", "en": "light blue" }, "shape": { "zh": "圆形薄膜衣片，无刻痕", "en": "round film-coated tablet, not scored" }, "imprint": { "zh": "SP", "en": "SP" }, "scoreStatus": "not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_b01f54336fd75a97", "label": "DailyMed（NLM）：CLARINEX 地氯雷他定 5 mg 薄膜衣片当前美国处方标签（SPL v6，2025-05-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c671342e-69a2-4ca5-abc2-8166ed4240d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-clarinex-desloratadine-tablet-5mg-100-bottle-ndc-78206-119-01", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=clarinex-02.jpg&setid=c671342e-69a2-4ca5-abc2-8166ed4240d4&type=img", "alt": "美国 CLARINEX 地氯雷他定 5 mg、NDC 78206-119-01、100 片瓶装 DailyMed 官方标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国处方品牌标签（SPL v6，2025-05-28 发布）", "presentation": "CLARINEX 5 mg：每片 5 mg，浅蓝色圆形无刻痕片，印有 C5；NDC 78206-119-01，100 片瓶装。", "notice": "此图只对应这一美国品牌包装。另一个当前 NDC 的片面印记为 SP；图像不用于鉴定真伪，也不能证明实时库存、其他厂家或市场，更不能生成个人用药方案。", "source": { "id": "src_b01f54336fd75a97", "label": "DailyMed（NLM）：CLARINEX 地氯雷他定 5 mg 薄膜衣片当前美国处方标签（SPL v6，2025-05-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c671342e-69a2-4ca5-abc2-8166ed4240d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "CLARINEX 说明书放大阅读：5 mg、100 片、嗜睡、肝肾功能与重复抗组胺药", "en": "CLARINEX enlarged label: 5 mg, 100 tablets, sleepiness, liver/kidney function and duplicate antihistamines" }, "summary": { "zh": "5 mg 是一片中的药量，100 片是瓶内数量，不是个人每天片数。当前美国品牌标签只展示普通片；品牌口服液和口崩片虽保留在临床文字中，但已不再销售。网页帮助读懂准确产品和风险问题，不计算个人频率、疗程、减量或换药。", "en": "Five mg is the amount in one tablet and 100 is the number of tablets in the bottle, not an individual's daily count. The current U.S. brand label displays only immediate-release tablets; the brand oral solution and orally disintegrating tablets remain in clinical text but are no longer marketed. The site explains exact-product and safety questions without calculating individual frequency, course, taper or switching." }, "checks": [ { "zh": "两个当前瓶装产品都是每片 5 mg、每瓶 100 片，但 NDC 与药片印记不同：78206-119-01 对应 C5，78206-188-01 对应 SP。名称或颜色相近不能代替 NDC、剂型、强度、包装和标签日期的完整核对。", "en": "Both current bottles contain 5 mg per tablet and 100 tablets, but their NDCs and imprints differ: 78206-119-01 is C5 and 78206-188-01 is SP. A similar name or colour cannot replace a complete check of NDC, dosage form, strength, pack and label date." }, { "zh": "标签写明肝功能或肾功能受损成人需要不同的起始安排。网页不把该文字转换为个人隔日、减半或停药指令；老人或有肝肾问题者应让医生或药师结合实际产品、检验和完整药单判断。", "en": "The label states that adults with hepatic or renal impairment need a different starting arrangement. This page does not convert that text into an individual alternate-day, half-tablet or stopping instruction; older adults and people with liver or kidney problems need the exact product, clinical information and complete medicine list reviewed by a clinician or pharmacist." }, { "zh": "标签列有疲劳、嗜睡、眩晕等信息，也要求告知医生所有处方药、非处方药、维生素和草药。老人和多药使用者应特别核对跌倒、驾驶和重复抗组胺药风险，不要靠自行错开时间假定叠加风险消失。", "en": "The label includes fatigue, sleepiness and dizziness and asks patients to disclose prescription medicines, nonprescription medicines, vitamins and herbs. Older adults and people using multiple medicines should review falls, driving and duplicate-antihistamine risks rather than assume self-spacing removes combined effects." }, { "zh": "皮疹、荨麻疹、面唇舌喉肿胀、呼吸困难可能是严重过敏反应线索。呼吸困难或面舌喉肿胀应立即使用当地急救渠道；网页搜索不能代替急救。", "en": "Rash, hives, swelling of the face, lips, tongue or throat, and breathing difficulty can signal a serious hypersensitivity reaction. Breathing difficulty or facial, tongue or throat swelling requires local emergency help; website search cannot replace emergency care." } ], "source": { "id": "src_b01f54336fd75a97", "label": "DailyMed（NLM）：CLARINEX 地氯雷他定 5 mg 薄膜衣片当前美国处方标签（SPL v6，2025-05-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c671342e-69a2-4ca5-abc2-8166ed4240d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "地氯雷他定怎样起作用：外周 H1 受体拮抗不等于所有抗组胺药可互换", "en": "How desloratadine works: peripheral H1 antagonism does not make antihistamines interchangeable" }, "summary": { "zh": "标签将地氯雷他定描述为长效 H1 受体拮抗剂，并说明它是氯雷他定的主要活性代谢物。该机制帮助理解过敏症状通路，但不证明症状一定由过敏引起，也不建立与氯雷他定、西替利嗪、左西替利嗪、非索非那定或苯海拉明的 mg 换算、同服或轮换规则。", "en": "The label describes desloratadine as a long-acting H1-receptor antagonist and the major active metabolite of loratadine. This helps explain an allergy pathway but does not prove symptoms are allergic or create milligram conversion, combination or rotation rules with loratadine, cetirizine, levocetirizine, fexofenadine or diphenhydramine." }, "checks": [ { "zh": "CLARINEX 与 CLARITIN 名称和成分关系密切，但不是同一个准确产品；不能因为“是代谢物”就在家自行按 mg 换算、叠加或隔天轮换。", "en": "CLARINEX and CLARITIN are closely related in name and chemistry but are not the same exact product; being a metabolite does not support home milligram conversion, combination or alternate-day rotation." }, { "zh": "CLARINEX-D 12 HOUR 还含伪麻黄碱，并且是缓释复方片；它不是本页的单成分普通片。鼻塞患者尤其要核对完整成分，避免把复方产品当成普通 CLARINEX。", "en": "CLARINEX-D 12 HOUR also contains pseudoephedrine and is an extended-release combination tablet; it is not the single-ingredient immediate-release tablet in this dossier. People checking congestion products should compare the full ingredient list rather than treat the combination as ordinary CLARINEX." }, { "zh": "同属抗组胺药不代表疗效、副作用、肝肾处理或剂型相同。出现持续或不明原因症状，应由专业人员核对诊断和完整药单，而不是在同类药之间自行试换。", "en": "Belonging to the antihistamine class does not make efficacy, adverse effects, liver/kidney handling or dosage forms identical. Persistent or unexplained symptoms need professional review of the diagnosis and complete medicine list rather than self-switching within the class." } ], "source": { "id": "src_b01f54336fd75a97", "label": "DailyMed（NLM）：CLARINEX 地氯雷他定 5 mg 薄膜衣片当前美国处方标签（SPL v6，2025-05-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c671342e-69a2-4ca5-abc2-8166ed4240d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "CLARINEX", "generic": "地氯雷他定片", "dosageFormClass": "普通薄膜衣口服片。5 mg 表示每片含有的地氯雷他定量，100 表示每瓶片数；两个数字不能相乘或直接变成个人每天吃几片。口服液浓度、口崩片和含伪麻黄碱的 CLARINEX-D 是不同产品身份，不能混算。" }, "labelSource": { "id": "src_b01f54336fd75a97", "label": "DailyMed（NLM）：CLARINEX 地氯雷他定 5 mg 薄膜衣片当前美国处方标签（SPL v6，2025-05-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c671342e-69a2-4ca5-abc2-8166ed4240d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" }, "productRoutes": [ { "source": { "id": "src_b01f54336fd75a97", "label": "DailyMed（NLM）：CLARINEX 地氯雷他定 5 mg 薄膜衣片当前美国处方标签（SPL v6，2025-05-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c671342e-69a2-4ca5-abc2-8166ed4240d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" }, "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": "2026-09-03", "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": "2026-09-03", "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": "CLARINEX 是地氯雷他定品牌档案。普通人应先认清：5 mg 是每片含量，100 是一瓶的总片数；当前美国品牌公开记录只有普通片，品牌口服液与口崩片已不再销售。老人、多药使用者以及有肝肾问题、嗜睡、眩晕或跌倒风险的人，应带完整药单核对重复抗组胺药和镇静影响，不能依据网页自行增加频率、换药或与 Claritin/氯雷他定、XYZAL、ZYRTEC 等叠加。", "history": "FDA 资料显示 CLARINEX 地氯雷他定 5 mg 普通片于 2001 年获批；口崩片和口服液随后以各自 NDA 获批。2014 年 FDA 批准函记录多剂型标签更新；当前 DailyMed 标签保留多剂型临床信息，但明确品牌口服液和 RediTabs 已不再销售，并展示现行 5 mg 普通片包装。", "sourceDocuments": [ { "id": "src_b01f54336fd75a97", "label": "DailyMed（NLM）：CLARINEX 地氯雷他定 5 mg 薄膜衣片当前美国处方标签（SPL v6，2025-05-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c671342e-69a2-4ca5-abc2-8166ed4240d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" }, { "id": "src_041a6e68c6b7812c", "label": "FDA：CLARINEX 地氯雷他定片、口服液与 RediTabs 补充批准函（2014-05-06）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021165Orig1s017,021300Orig1s014,021312Orig1s015,021563Orig1s003ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" } ], "applicationNumber": "NDA 021165", "approvalTimeline": [ { "date": "2001-12-21", "title": { "zh": "CLARINEX 5 mg 普通片在美国获批", "en": "U.S. approval of CLARINEX 5 mg tablets" }, "detail": { "zh": "FDA 资料将 NDA 021165 与 5 mg 地氯雷他定普通片首次批准相连。", "en": "FDA materials link NDA 021165 to the initial approval of 5 mg desloratadine tablets." }, "source": { "id": "src_041a6e68c6b7812c", "label": "FDA：CLARINEX 地氯雷他定片、口服液与 RediTabs 补充批准函（2014-05-06）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021165Orig1s017,021300Orig1s014,021312Orig1s015,021563Orig1s003ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" } }, { "date": "2014-05-06", "title": { "zh": "FDA 批准多剂型标签更新", "en": "FDA approved multi-formulation labelling updates" }, "detail": { "zh": "补充批准函覆盖普通片、口服液与 RediTabs，并加入上市后运动障碍相关措辞。", "en": "The supplement approval covers tablets, oral solution and RediTabs and adds postmarketing movement-disorder wording." }, "source": { "id": "src_041a6e68c6b7812c", "label": "FDA：CLARINEX 地氯雷他定片、口服液与 RediTabs 补充批准函（2014-05-06）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021165Orig1s017,021300Orig1s014,021312Orig1s015,021563Orig1s003ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" } }, { "date": "2025-05-28", "title": { "zh": "当前 DailyMed SPL v6 发布", "en": "Current DailyMed SPL v6 published" }, "detail": { "zh": "当前记录展示两种 5 mg、100 片瓶装包装，并说明品牌口服液和口崩片已不再销售。", "en": "The current record displays two 5 mg, 100-tablet bottles and says the brand oral solution and orally disintegrating tablets are no longer marketed." }, "source": { "id": "src_b01f54336fd75a97", "label": "DailyMed（NLM）：CLARINEX 地氯雷他定 5 mg 薄膜衣片当前美国处方标签（SPL v6，2025-05-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c671342e-69a2-4ca5-abc2-8166ed4240d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前品牌处方片公开标签", "en": "Current public brand prescription-tablet label" }, "detail": { "zh": "NDA 021165；5 mg 普通片，两个 100 片瓶装 NDC。", "en": "NDA 021165; 5 mg immediate-release tablets in two 100-tablet bottle NDCs." } }, { "market": { "zh": "美国品牌其他剂型", "en": "Other U.S. brand dosage forms" }, "status": { "zh": "口服液与 RediTabs 已不再销售", "en": "Oral solution and RediTabs no longer marketed" }, "detail": { "zh": "临床文字仍可见，但不能据此声称当前品牌有货。", "en": "Clinical text remains visible but does not establish current brand availability." } }, { "market": { "zh": "美国以外", "en": "Outside the United States" }, "status": { "zh": "本档案未确认当地产品", "en": "Local products not established in this dossier" }, "detail": { "zh": "需回到当地监管记录和手中药盒。", "en": "Check the local regulator and the pack in hand." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "5 mg 和 100 片分别是什么意思？", "en": "What do 5 mg and 100 tablets mean?" }, "answer": { "zh": "5 mg 是每片地氯雷他定含量，100 片是这瓶中的片数。它们是产品身份字段，不等于任何人的每日片数、使用频率或疗程。", "en": "Five mg is the amount of desloratadine in each tablet; 100 tablets is the count in the bottle. These are product-identity fields, not an individual's daily count, frequency or course." } }, { "question": { "zh": "能和 Claritin、XYZAL、ZYRTEC 或感冒药一起吃吗？", "en": "Can it be taken with Claritin, XYZAL, ZYRTEC or a cold medicine?" }, "answer": { "zh": "网页不能作出这个决定。很多处方和 OTC 感冒／过敏产品会重复抗组胺成分或增加嗜睡；应把每个实际包装的完整成分表和药单交给药师或医生核对。", "en": "A website cannot make that decision. Many prescription and OTC cold/allergy products duplicate antihistamines or add sedation; give a pharmacist or clinician the full ingredient lists from every actual pack and the complete medicine list." } }, { "question": { "zh": "没有 C5 印记就是假药吗？", "en": "Does an imprint other than C5 mean counterfeit?" }, "answer": { "zh": "不能这样判断。当前官方标签本身就列出 C5 和 SP 两种印记、两个 NDC；其他厂家和市场还可能不同。网页图像与 OCR 不能鉴定真伪，应通过药师、授权供应链和当地监管渠道核验。", "en": "No. The current official label itself lists both C5 and SP imprints with different NDCs, and other manufacturers or markets may differ. Website images and OCR cannot authenticate a medicine; use a pharmacist, authorised supply chain and local regulator." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/clarinex-desloratadine/", "en": "https://origindrug.com/en/drugs/clarinex-desloratadine/" }, "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." ] }