{ "id": "aleve", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-25", "status": "published_traceable_archive" }, "names": { "brand": "ALEVE", "generic": "萘普生钠", "aliases": [ "ALEVE", "naproxen", "naproxen sodium", "萘普生", "萘普生钠", "0280-0114-01", "0280-0114-02" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "疼痛与炎症", "sourceArchiveMarket": "美国：DailyMed 当前 ALEVE CAPLETS 公开标签（SPL v4，2026-03-12 更新）列示萘普生钠 220 mg（相当于萘普生 200 mg）的蓝色、胶囊形、无刻痕口服片，及多个准确瓶装 NDC。本页只展示 24 片与 200 片两组标签包装；不建立中国大陆、欧盟、日本或其他市场的商品名、批准、供应、可售资格、原研/仿制关系或可替代性。", "dosageFormClass": "萘普生钠口服片：每片标签标示萘普生钠 220 mg（标签同时注明相当于萘普生 200 mg；不是两个可相加的剂量）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "NDA 020204（所引美国现行 OTC 标签列示；不据此推定其他市场状态）", "archiveSponsorText": "Bayer HealthCare LLC（所引美国现行公开标签所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "Aleve liquid-filled capsule", "Aleve PM", "Aleve Back & Muscle", "other naproxen package", "萘普生钠软胶囊", "其他萘普生包装" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-aleve-naproxen-sodium-tablet-220mg-200-bottle-ndc-0280-0114-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v4（2026-03-12 更新）", "en": "DailyMed SPL v4 (updated 12 Mar 2026)" }, "dosageForm": { "zh": "无刻痕胶囊形口服片", "en": "unscored capsule-shaped oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [], "productCode": "NDC 0280-0114-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "ALEVE CAPLETS 萘普生钠 220 mg、200 片瓶装", "en": "ALEVE CAPLETS naproxen sodium 220 mg, 200-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Aleve+Caplets+Blusheild+-+200+Count+Carton.jpg&setid=02941928-128a-2c88-e063-6294a90ac6ba&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "萘普生钠（每片）", "en": "Naproxen sodium (per tablet)" }, "value": 220, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；标签同时注明相当于萘普生 200 mg，不是两个可相加的量", "en": "Labelled amount per tablet; the label also states naproxen 200 mg equivalent, not two additive amounts" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 200, "unit": { "zh": "片", "en": "tablets" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "椭圆/胶囊形", "en": "oval/capsule-shaped" }, "imprint": { "zh": "Aleve", "en": "Aleve" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_896c1a02d3db0626", "label": "DailyMed (NLM): ALEVE CAPLETS 220 mg, NDC 0280-0114-01, 200-tablet bottle panel (Bayer; SPL v4)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=02941928-128a-2c88-e063-6294a90ac6ba&version=4", "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-aleve-naproxen-sodium-tablet-220mg-24-bottle-ndc-0280-0114-02", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v4（2026-03-12 更新）", "en": "DailyMed SPL v4 (updated 12 Mar 2026)" }, "dosageForm": { "zh": "无刻痕胶囊形口服片", "en": "unscored capsule-shaped oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [], "productCode": "NDC 0280-0114-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "ALEVE CAPLETS 萘普生钠 220 mg、24 片瓶装", "en": "ALEVE CAPLETS naproxen sodium 220 mg, 24-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "萘普生钠（每片）", "en": "Naproxen sodium (per tablet)" }, "value": 220, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；标签同时注明相当于萘普生 200 mg，不是两个可相加的量", "en": "Labelled amount per tablet; the label also states naproxen 200 mg equivalent, not two additive amounts" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 24, "unit": { "zh": "片", "en": "tablets" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "椭圆/胶囊形", "en": "oval/capsule-shaped" }, "imprint": { "zh": "Aleve", "en": "Aleve" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_896c1a02d3db0626", "label": "DailyMed (NLM): ALEVE CAPLETS 220 mg, NDC 0280-0114-02, 24-tablet bottle listing (Bayer; SPL v4)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=02941928-128a-2c88-e063-6294a90ac6ba&version=4", "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-aleve-naproxen-sodium-tablet-220mg-200-bottle-ndc-0280-0114-01", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Aleve+Caplets+Blusheild+-+200+Count+Carton.jpg&setid=02941928-128a-2c88-e063-6294a90ac6ba&type=img", "alt": "ALEVE CAPLETS 萘普生钠 220 mg、NDC 0280-0114-01、200 片瓶装在美国 DailyMed 现行公开标签中的包装图", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v4（2026-03-12 更新）", "presentation": "ALEVE CAPLETS 萘普生钠：每片标签标示 220 mg，NDC 0280-0114-01，200 片瓶装（美国现行公开标签）。", "notice": "此图只对应所引美国 DailyMed 标签中的 ALEVE CAPLETS、萘普生钠 220 mg、NDC 0280-0114-01 与 200 片瓶装。它帮助核对品牌、成分、每片标示量、包装、外观和来源；不用于鉴定真伪，也不代表软胶囊、PM/复方、其他萘普生包装、其他 NSAID、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_896c1a02d3db0626", "label": "DailyMed (NLM): current U.S. ALEVE CAPLETS naproxen sodium public label (Bayer; SPL v4, updated 12 Mar 2026)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=02941928-128a-2c88-e063-6294a90ac6ba&version=4", "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": "ALEVE／萘普生钠说明书放大阅读：先看清 220 mg 与“相当于 200 mg”", "en": "ALEVE label reading: first distinguish 220 mg from the stated 200 mg equivalent" }, "summary": { "zh": "本模块只阅读所引美国 OTC 标签中的 ALEVE CAPLETS、准确片剂、成分标示、NDC、包装、外形与警示。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 ALEVE CAPLETS, the exact tablet, labelled ingredient fields, NDC, package, appearance and warnings in the cited U.S. OTC label. It provides no individual tablet count, timing, stopping, co-use, switching, splitting or purchase plan." }, "checks": [ { "zh": "萘普生钠 220 mg 与标签括号中的萘普生 200 mg 是同一片剂的标示与活性部分等效信息，不是两份药量。不要把两个数字相加、换算成个人片数，或拿来和其他萘普生、布洛芬、阿司匹林或止痛产品自行比较。", "en": "Naproxen sodium 220 mg and the label’s parenthetical naproxen 200 mg refer to the same tablet’s labelled and active-moiety-equivalent information, not two medicine amounts. Do not add the numbers, convert them into a personal tablet count, or use them to self-compare another naproxen, ibuprofen, aspirin or pain product." }, { "zh": "所引 ALEVE 片为蓝色、无刻痕、胶囊形并压印 Aleve。外观只用于辅助核对；无刻痕不是分片许可，包装数量和“OTC”也不构成自行增加、轮换或与同类止痛药叠加的依据。", "en": "The cited ALEVE tablet is blue, unscored, capsule-shaped and imprinted Aleve. Appearance is only a supporting check; an unscored tablet is not splitting permission, and package count or OTC status does not justify self-increase, alternation or combination with another pain medicine." }, { "zh": "标签列出胃出血、心脏/卒中相关警示，并特别把 60 岁及以上、抗凝药或激素类药物、其他处方或非处方 NSAID、饮酒和肾脏/心血管问题列为需要专业核对的情境。请将所有药盒、非处方药、补充剂和酒精使用情况交给药师或医生；不要因品牌不同自行叠加。", "en": "The label includes stomach-bleeding and heart/stroke warnings, and specifically identifies age 60 or older, anticoagulant or steroid medicines, other prescription or OTC NSAIDs, alcohol, and kidney/cardiovascular conditions as contexts requiring professional review. Give every pack, OTC product, supplement and alcohol-use context to a pharmacist or clinician; different brands do not justify self-combining." }, { "zh": "黑便或血便、呕血、晕厥、胸痛、呼吸困难、单侧无力、言语含糊、面部肿胀或其他急性令人担心的问题，应优先使用当地紧急医疗支持；不要等待网页检索或同时改变多种药来试探原因。", "en": "With black or bloody stools, vomiting blood, fainting, chest pain, breathing difficulty, one-sided weakness, slurred speech, facial swelling or another acute worrying problem, prioritise local urgent medical support; do not wait for a webpage search or change several medicines to test the cause." } ], "source": { "id": "src_896c1a02d3db0626", "label": "DailyMed (NLM): current U.S. ALEVE CAPLETS public label (warnings and Drug Facts; Bayer; SPL v4)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=02941928-128a-2c88-e063-6294a90ac6ba&version=4", "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": "萘普生钠怎样起作用：NSAID 类别术语不是自行联用规则", "en": "How naproxen sodium works: NSAID class terminology is not a self-combination rule" }, "summary": { "zh": "标签把萘普生钠归入 NSAID。本页用这一术语帮助读者识别类别与警示；不诊断疼痛或发热原因，也不判断是否应使用、与阿司匹林/布洛芬/塞来昔布等如何衔接、能否联用或何时停止。", "en": "The label classifies naproxen sodium as an NSAID. This page uses that term to help identify its class and warnings; it does not diagnose pain or fever, or decide whether to use it, how it relates to aspirin, ibuprofen or celecoxib, whether products can be combined, or when to stop." }, "checks": [ { "zh": "“同为 NSAID”是重复风险核对线索，不是可以互换或叠加的理由。每种实际产品、剂型、目标市场标签、完整药单和既往反应都需由专业人员一起核对。", "en": "“Same NSAID class” is a clue to check for duplication risk, not a reason to substitute or combine. Each actual product, dosage form, target-market label, complete medicine list and prior reaction needs professional review together." }, { "zh": "机制页不能解释个人的胃痛、黑便、头晕、血压、肾功能、胸痛、呼吸困难或其他症状，也不能替代对抗凝药、阿司匹林、其他止痛药、补充剂和饮酒情况的核对。", "en": "A mechanism page cannot explain an individual’s stomach pain, black stools, dizziness, blood pressure, kidney function, chest pain, breathing difficulty or another symptom, nor replace review of anticoagulants, aspirin, other pain medicines, supplements and alcohol use." }, { "zh": "出现急性严重或令人担心的不适时，应优先使用当地紧急医疗渠道；不要依据“NSAID”或包装文字自行改变多个产品。", "en": "With an acute severe or worrying problem, use local urgent medical pathways first; do not change several products yourself from an NSAID label or package text." } ], "source": { "id": "src_896c1a02d3db0626", "label": "DailyMed (NLM): current U.S. ALEVE CAPLETS public label (Drug Facts; Bayer; SPL v4)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=02941928-128a-2c88-e063-6294a90ac6ba&version=4", "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": "ALEVE", "generic": "萘普生钠", "dosageFormClass": "萘普生钠口服片：每片标签标示萘普生钠 220 mg（标签同时注明相当于萘普生 200 mg；不是两个可相加的剂量）" }, "labelSource": { "id": "src_896c1a02d3db0626", "label": "DailyMed (NLM): current U.S. ALEVE CAPLETS naproxen sodium public label (Bayer; SPL v4, updated 12 Mar 2026)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=02941928-128a-2c88-e063-6294a90ac6ba&version=4", "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_896c1a02d3db0626", "label": "DailyMed (NLM): current U.S. ALEVE CAPLETS naproxen sodium public label (Bayer; SPL v4, updated 12 Mar 2026)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=02941928-128a-2c88-e063-6294a90ac6ba&version=4", "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 ALEVE CAPLETS 标签列示萘普生钠 220 mg（标签同时解释为萘普生 200 mg）、蓝色无刻痕胶囊形口服片和多种瓶装。本页先帮读者核对成分、两种标签数字、准确包装与公开说明书；“OTC”“止痛”或同为 NSAID 不能让它与布洛芬、阿司匹林、塞来昔布或其他产品自行叠加、轮换或替换。", "history": "所引标签为 Bayer HealthCare LLC 的美国 OTC 公开标签，SPL v4 更新于 2026-03-12。220 mg 萘普生钠与“相当于 200 mg 萘普生”是同一片剂的两个标签身份字段，不是两种成分或两个可相加的用药量；液体胶囊、PM/复方、其他萘普生包装和其他市场产品须另按准确标签核对。", "sourceDocuments": [ { "id": "src_896c1a02d3db0626", "label": "DailyMed (NLM): current U.S. ALEVE CAPLETS naproxen sodium public label (Bayer; SPL v4, updated 12 Mar 2026)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=02941928-128a-2c88-e063-6294a90ac6ba&version=4", "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": "NDA 020204（所引美国现行 OTC 标签列示）", "approvalTimeline": [ { "date": "NDA 020204", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: NDA 020204。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: NDA 020204. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_896c1a02d3db0626", "label": "DailyMed: ALEVE CAPLETS naproxen sodium U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=02941928-128a-2c88-e063-6294a90ac6ba&version=4", "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" } }, { "date": "2026-03-12 updated public label (SPL v4)", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2026-03-12 updated public label (SPL v4) 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2026-03-12 updated public label (SPL v4) FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_896c1a02d3db0626", "label": "DailyMed: ALEVE CAPLETS naproxen sodium U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=02941928-128a-2c88-e063-6294a90ac6ba&version=4", "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": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA 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": "不从美国标签档案推定当地批准、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. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/aleve/", "en": "https://origindrug.com/en/drugs/aleve/" }, "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." ] }