{ "id": "benadryl", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-25", "status": "published_traceable_archive" }, "names": { "brand": "BENADRYL", "generic": "盐酸苯海拉明", "aliases": [ "BENADRYL", "diphenhydramine", "diphenhydramine hydrochloride", "苯海拉明", "盐酸苯海拉明", "50580-226-12", "50580-226-50" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "呼吸系统", "sourceArchiveMarket": "美国：DailyMed 当前 BENADRYL 盐酸苯海拉明 25 mg 薄膜衣片公开标签（SPL v31，2026-02-06 更新）；本页仅展示标签明确列出的两组准确包装身份，不建立中国大陆、欧盟、日本或其他市场的批准、供应、可售或原研/仿制结论。", "dosageFormClass": "盐酸苯海拉明 25 mg 薄膜衣口服片：准确包装、标签警示和产品族边界必须同时核对", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "DailyMed SPL v31（2026-02-06 更新的美国 OTC 公开标签；不据此推定其他市场状态）", "archiveSponsorText": "Kenvue Brands LLC（所引美国现行公开标签所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "BENADRYL Allergy Plus Congestion", "BENADRYL Allergy & Sinus", "BENADRYL Extra Strength Itch Stopping Gel", "BENADRYL topical", "BENADRYL liquid", "BENADRYL children's", "other diphenhydramine package", "其他苯海拉明包装" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-benadryl-diphenhydramine-hcl-tablet-25mg-12blister-ndc-50580-226-12", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v31（2026-02-06 更新）", "en": "DailyMed SPL v31 (updated 6 Feb 2026)" }, "dosageForm": { "zh": "薄膜衣口服片", "en": "film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50580-226-12", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "BENADRYL 盐酸苯海拉明 25 mg、12 片泡罩装", "en": "BENADRYL diphenhydramine hydrochloride 25 mg, 12-tablet blister pack" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=benadryl-01.jpg&archiveid=946509", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸苯海拉明（每片）", "en": "Diphenhydramine hydrochloride (per tablet)" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、间隔或一日总量", "en": "Labelled amount per tablet; not an individual's tablet count, timing interval or daily total" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 12, "unit": { "zh": "片/泡罩装", "en": "tablets per blister pack" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_4d998d797254abdd", "label": "DailyMed (NLM): BENADRYL 25 mg, NDC 50580-226-12, 12-tablet blister-pack panel (Kenvue; SPL v31)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=702f9786-7ce9-43e4-921d-e1db09612127&version=31", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-benadryl-diphenhydramine-hcl-tablet-25mg-100bottle-ndc-50580-226-50", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v31（2026-02-06 更新）", "en": "DailyMed SPL v31 (updated 6 Feb 2026)" }, "dosageForm": { "zh": "薄膜衣口服片", "en": "film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50580-226-50", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "BENADRYL 盐酸苯海拉明 25 mg、100 片瓶装", "en": "BENADRYL diphenhydramine hydrochloride 25 mg, 100-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸苯海拉明（每片）", "en": "Diphenhydramine hydrochloride (per tablet)" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、间隔或一日总量", "en": "Labelled amount per tablet; not an individual's tablet count, timing interval or daily total" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_4d998d797254abdd", "label": "DailyMed (NLM): BENADRYL 25 mg, NDC 50580-226-50, 100-tablet bottle listing (Kenvue; SPL v31)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=702f9786-7ce9-43e4-921d-e1db09612127&version=31", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-benadryl-diphenhydramine-hcl-tablet-25mg-12blister-ndc-50580-226-12", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=benadryl-01.jpg&archiveid=946509", "alt": "BENADRYL 盐酸苯海拉明 25 mg、NDC 50580-226-12、12 片泡罩装在美国 DailyMed 现行公开标签中的包装图", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v31（2026-02-06 更新）", "presentation": "BENADRYL 盐酸苯海拉明：每片 25 mg，NDC 50580-226-12，12 片泡罩装（美国现行公开标签）。", "notice": "此图只对应所引美国 DailyMed 标签中的 BENADRYL、盐酸苯海拉明 25 mg、NDC 50580-226-12 与 12 片泡罩装。它帮助核对品牌、成分、每片标示量、包装和来源；不用于鉴定真伪，也不代表复方、夜用/感冒、外用、儿童、液体、其他苯海拉明包装、其他市场、原研身份、可替代性或任何个人的服用、联用、停用、换药或分片方案。", "source": { "id": "src_4d998d797254abdd", "label": "DailyMed (NLM): current U.S. BENADRYL diphenhydramine hydrochloride public label (Kenvue; SPL v31, updated 6 Feb 2026)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=702f9786-7ce9-43e4-921d-e1db09612127&version=31", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "BENADRYL／苯海拉明说明书放大阅读：先核对是否已经有其他苯海拉明", "en": "BENADRYL label reading: first check for another diphenhydramine product" }, "summary": { "zh": "本模块只阅读所引美国 OTC 标签中的 BENADRYL 薄膜衣片、每片标示量、NDC、包装和警示。它不提供个人片数、服用间隔、停用、联用、换药、分片或购买方案。", "en": "This module reads only the cited U.S. OTC BENADRYL film-coated tablet, labelled amount per tablet, NDC, package and warnings. It provides no individual tablet count, timing, stopping, co-use, switching, splitting or purchase plan." }, "checks": [ { "zh": "标签明确写明不要与任何其他含苯海拉明产品合用，包括皮肤外用产品。先把所有“夜用”“感冒”“止痒”“过敏”、处方、非处方和外用产品的成分表交给药师或医生核对；同一成分可能藏在不同名称和不同剂型中。", "en": "The label explicitly says not to use with any other product containing diphenhydramine, including a product used on the skin. First have a pharmacist or clinician review the ingredient panels of every “night-time,” cold, itch, allergy, prescription, OTC and topical product; the same ingredient can appear under different names and forms." }, { "zh": "每片 25 mg 只识别所引薄膜衣片的标签成分字段；12 片泡罩装或 100 片瓶装只是包装身份。它们不构成个人片数、间隔、补用、加倍、联用或换药规则。", "en": "The 25 mg field identifies only the labelled ingredient in the cited film-coated tablet; the 12-tablet blister and 100-tablet bottle are package identities. They do not establish individual tablet count, timing, catch-up, doubling, co-use or switching rules." }, { "zh": "标签提示显著嗜睡，酒精、镇静药和安定类药物可能增加嗜睡，并提示驾驶或操作机械时谨慎。若实际药单中已有这些项目、或出现跌倒、明显困倦、意识改变、呼吸困难或其他急性担忧，应优先联系当地医疗支持；不要从网页自行增减或叠加产品。", "en": "The label warns that marked drowsiness may occur, that alcohol, sedatives and tranquilizers may increase drowsiness, and that driving or operating machinery needs caution. If the actual medicine list already includes these items, or there is a fall, marked sleepiness, change in consciousness, breathing difficulty or another acute concern, prioritise local medical support; do not self-adjust or combine products from a webpage." }, { "zh": "标签把青光眼、慢性呼吸问题及因前列腺增大导致排尿困难列为需要先咨询的情境。网页不能据此判断任何人是否适合用药；请将准确药盒、症状和完整药单交给药师或医生。", "en": "The label lists glaucoma, chronic breathing problems and trouble urinating due to an enlarged prostate as situations requiring prior consultation. A webpage cannot determine whether any person can use the product; bring the exact package, symptoms and complete medicine list to a pharmacist or clinician." } ], "source": { "id": "src_4d998d797254abdd", "label": "DailyMed (NLM): current U.S. BENADRYL public label (warnings and Drug Facts; Kenvue; SPL v31)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=702f9786-7ce9-43e4-921d-e1db09612127&version=31", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "苯海拉明怎样起作用：抗组胺类别术语不能用来推导“夜用”方案", "en": "How diphenhydramine works: an antihistamine class term cannot create a night-time plan" }, "summary": { "zh": "标签将盐酸苯海拉明列为抗组胺药。本页用这一类别帮助读者检查成分重复和嗜睡警示；不诊断症状来源，也不判断是否应使用、怎样与其他过敏、感冒、镇静或外用产品衔接。", "en": "The label lists diphenhydramine hydrochloride as an antihistamine. This page uses that class to help check ingredient duplication and drowsiness warnings; it does not diagnose symptoms or decide whether to use it, or how it relates to another allergy, cold, sedating or topical product." }, "checks": [ { "zh": "“抗组胺”“夜用”或“止痒”不是自行把多种产品叠加的理由。不同产品可能包含苯海拉明、其他抗组胺成分或多种成分；必须逐项按实际包装和完整药单核对。", "en": "“Antihistamine,” “night-time,” or “itch relief” is not a reason to self-combine products. Different products may contain diphenhydramine, another antihistamine or multiple ingredients; check each actual package and the complete medicine list." }, { "zh": "机制页不能解释一个人的失眠、跌倒、困倦、头晕、视物异常、排尿困难、呼吸问题或其他症状，也不能替代对酒精、镇静药、抗焦虑药、处方药和外用产品的核对。", "en": "A mechanism page cannot explain an individual's insomnia, fall, sleepiness, dizziness, visual symptom, urination difficulty, breathing problem or another symptom, nor replace review of alcohol, sedatives, anxiety medicines, prescriptions and topical products." }, { "zh": "出现意识改变、呼吸困难、昏厥、严重过敏、跌倒受伤或其他急性担忧时，应优先使用当地紧急医疗渠道；不要同时改变多种药来试探原因。", "en": "With altered consciousness, breathing difficulty, fainting, severe allergy, injury from a fall or another acute concern, use local urgent medical pathways first; do not change several medicines at once to test the cause." } ], "source": { "id": "src_4d998d797254abdd", "label": "DailyMed (NLM): current U.S. BENADRYL public label (Drug Facts; Kenvue; SPL v31)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=702f9786-7ce9-43e4-921d-e1db09612127&version=31", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "BENADRYL", "generic": "盐酸苯海拉明", "dosageFormClass": "盐酸苯海拉明 25 mg 薄膜衣口服片：准确包装、标签警示和产品族边界必须同时核对" }, "labelSource": { "id": "src_4d998d797254abdd", "label": "DailyMed (NLM): current U.S. BENADRYL diphenhydramine hydrochloride public label (Kenvue; SPL v31, updated 6 Feb 2026)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=702f9786-7ce9-43e4-921d-e1db09612127&version=31", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "productRoutes": [ { "source": { "id": "src_4d998d797254abdd", "label": "DailyMed (NLM): current U.S. BENADRYL diphenhydramine hydrochloride public label (Kenvue; SPL v31, updated 6 Feb 2026)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=702f9786-7ce9-43e4-921d-e1db09612127&version=31", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "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": "2026-08-25", "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": "2026-08-25", "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": "美国 DailyMed 当前 BENADRYL 标签列示每片盐酸苯海拉明 25 mg，并特别提示不要与任何其他含苯海拉明产品（包括皮肤外用产品）合用。页面先帮助核对准确片剂、NDC、包装和嗜睡相关警示；“夜用”“感冒”“抗过敏”或相同成分不能让不同 BENADRYL 家族、复方、液体或外用产品自行叠加、轮换或替换。", "history": "所引标签为 Kenvue Brands LLC 的美国 OTC 公开标签，SPL v31 于 2026-02-06 更新。12 片泡罩装与 100 片瓶装是两个独立包装身份；每片 25 mg 是标签成分字段，不是个人片数、间隔或一日总量。其他含苯海拉明的夜用、感冒、皮肤外用、儿童或液体产品需要另按准确标签核对。", "sourceDocuments": [ { "id": "src_4d998d797254abdd", "label": "DailyMed (NLM): current U.S. BENADRYL diphenhydramine hydrochloride public label (Kenvue; SPL v31, updated 6 Feb 2026)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=702f9786-7ce9-43e4-921d-e1db09612127&version=31", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA official search", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "DailyMed U.S. OTC label record", "approvalTimeline": [ { "date": "DailyMed SPL v31, updated 2026-02-06", "title": { "zh": "DailyMed 公开标签版本", "en": "DailyMed public label version" }, "detail": { "zh": "本页链接 DailyMed SPL v31, updated 2026-02-06 的 DailyMed 美国 OTC 公开标签作为可复核阅读入口。它标识该具体公开标签，不推定初始批准年份、NDA 编号、当前供应、持有人或其他市场状态。", "en": "This page links the DailyMed SPL v31, updated 2026-02-06 DailyMed U.S. OTC public label as a traceable reading entry point. It identifies that specific public label and does not assert an original-approval year, NDA number, current availability, holder or another-market status." }, "source": { "id": "src_4d998d797254abdd", "label": "DailyMed: BENADRYL diphenhydramine hydrochloride current U.S. OTC label", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=702f9786-7ce9-43e4-921d-e1db09612127&version=31", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接 OTC 公开标签", "en": "OTC public label linked" }, "detail": { "zh": "仅对应本页所列 DailyMed OTC 文件。", "en": "Only the DailyMed OTC document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国 OTC 标签推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. OTC label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "美国 OTC 标签能代表其他市场或个人用法吗？", "en": "Does a U.S. OTC label represent another market or personal use?" }, "answer": { "zh": "不能。它仅是这一具体美国公开标签的阅读入口；目标市场的现行文件和个人情况必须分别由专业人员核对。", "en": "No. It is only a reading entry point for this specific U.S. public label; the current target-market document and individual circumstances need separate professional review." } }, { "question": { "zh": "为什么不把 OTC 档案写成原始批准或原研结论？", "en": "Why does the OTC archive not state original approval or originator conclusions?" }, "answer": { "zh": "标签记录不足以证明这些结论。它们需要可追溯的产品、剂型、市场、时间和一手监管记录，并经人工审核。", "en": "A label record is insufficient to prove those conclusions. They require traceable product, dosage-form, market, date and primary regulatory records with human review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/benadryl/", "en": "https://origindrug.com/en/drugs/benadryl/" }, "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." ] }