{ "id": "plan-b-one-step", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-04", "status": "published_traceable_archive" }, "names": { "brand": "PLAN B ONE-STEP", "generic": "左炔诺孕酮", "aliases": [ "PLAN B ONE-STEP", "Plan B One-Step", "levonorgestrel", "左炔诺孕酮", "左炔诺孕酮片", "NDA 021998", "69536-162-88", "G00", "levonorgestrel tablet", "NDC 69536-162-88" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "生殖健康", "sourceArchiveMarket": "美国当前 OTC Drug Facts 与 FDA 产品记录：PLAN B ONE-STEP 左炔诺孕酮 1.5 mg 单片零售包装；不外推其他市场批准、供应、商品名或使用规则", "dosageFormClass": "PLAN B ONE-STEP 左炔诺孕酮 1.5 mg 口服片：NDC 69536-162-88，每盒 1 板、每板 1 片", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2009-07-10（FDA Drugs@FDA 所列 NDA 021998 原始批准日期）", "archiveSponsorText": "Foundation Consumer Healthcare LLC / FDA 与 DailyMed 当前公开监管记录" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "NDC 69536-146-19（仅供诊所使用、非零售）", "历史双片 PLAN B 包装", "其他左炔诺孕酮 1.5 mg OTC 产品", "ella / ulipristal acetate", "常规复方口服避孕药", "宫内节育器" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-plan-b-one-step-levonorgestrel-1-5mg-one-tablet-blister-box-ndc-6953616288", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国 OTC Drug Facts（2023-01-31 更新；SPL v5）", "en": "Current U.S. DailyMed OTC Drug Facts (updated 31 Jan 2023; SPL v5)" }, "dosageForm": { "zh": "PLAN B ONE-STEP 左炔诺孕酮口服片", "en": "PLAN B ONE-STEP levonorgestrel oral tablet" }, "route": { "zh": "口服（美国 OTC 标签产品身份字段）", "en": "oral (U.S. OTC label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 69536-162-88", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片左炔诺孕酮 1.5 mg；每盒 1 板、每板 1 片", "en": "Levonorgestrel 1.5 mg per tablet; one blister with one tablet per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=plan-b-one-step-01.jpg&setid=6ce6b40e-14ac-47bd-a648-ddf9e452e559", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左炔诺孕酮", "en": "levonorgestrel" }, "value": 1.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；1.5 mg 不是包装片数，也不能单独生成个人使用方案", "en": "labelled amount per tablet; 1.5 mg is not a package count and cannot by itself generate an individual-use plan" } } ], "concentration": null, "container": { "typeCode": "single_tablet_blister_carton", "typeLabel": { "zh": "单片泡罩纸盒", "en": "single-tablet blister carton" }, "fill": null, "countPerPackage": 1, "countUnit": { "zh": "板/盒", "en": "blister per carton" }, "unitsPerContainer": { "count": 1, "unit": { "zh": "片/板", "en": "tablet per blister" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "片/盒", "en": "tablet per carton" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "圆形、无刻痕", "en": "round, unscored" }, "imprint": "G00", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_df073f3c4596f4b8", "label": "DailyMed（NLM）：PLAN B ONE-STEP 当前美国 OTC 标签与单片零售包装（SPL v5）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6ce6b40e-14ac-47bd-a648-ddf9e452e559", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-plan-b-one-step-levonorgestrel-1-5mg-one-tablet-blister-box-ndc-6953616288", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=plan-b-one-step-01.jpg&setid=6ce6b40e-14ac-47bd-a648-ddf9e452e559", "alt": "PLAN B ONE-STEP 左炔诺孕酮 1.5 mg、NDC 69536-162-88 单片零售包装的 DailyMed 标签图", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国 OTC Drug Facts（2023-01-31 更新；SPL v5）", "presentation": "白色至类白色圆形无刻痕片、G00 刻印、每板 1 片、每盒 1 板、NDC 69536-162-88", "notice": "此图只帮助核对所引美国零售标签的品牌、成分量、NDC、单片包装和外观；不用于鉴定真伪，也不覆盖诊所专用 NDC、其他市场或其他左炔诺孕酮产品。", "source": { "id": "src_df073f3c4596f4b8", "label": "DailyMed（NLM）：PLAN B ONE-STEP 当前美国 OTC 单片零售包装图（SPL v5）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6ce6b40e-14ac-47bd-a648-ddf9e452e559", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "PLAN B ONE-STEP 说明书放大阅读：先分清 1.5 mg 与一盒 1 片", "en": "PLAN B ONE-STEP label reading: separate 1.5 mg from the one-tablet pack" }, "summary": { "zh": "这一 Drug Facts 最容易读错的是把每片成分量、整盒片数和个人使用时点混成一件事。网页逐层解释所引美国标签，但不判断个人是否适用，也不生成重复使用、替换或衔接方案。", "en": "This Drug Facts can be misread by collapsing the per-tablet amount, carton count and an individual's timing into one thing. The page separates the cited U.S. label layers but does not decide suitability or generate repeat-use, substitution or transition plans." }, "checks": [ { "zh": "每片含左炔诺孕酮 1.5 mg；NDC 69536-162-88 每盒一板、一片。片剂为白色至类白色、圆形、G00 刻印且无刻痕。无刻痕和单片包装都不是自行掰半、改变含量或分次使用的依据。", "en": "Each tablet contains levonorgestrel 1.5 mg; NDC 69536-162-88 has one blister and one tablet per carton. The tablet is white to off-white, round, marked G00 and unscored. Neither the unscored tablet nor single-tablet pack permits self-splitting, dose alteration or divided use." }, { "zh": "所引美国 Drug Facts 写的是无保护性行为或避孕失败后尽快、并在 72 小时内使用；若两小时内呕吐，应联系专业人员。本页只复述这一准确美国标签，不能外推其他产品、市场或个人情况；时间敏感或不确定时应立即联系药师、医生或当地生殖健康服务。", "en": "The cited U.S. Drug Facts says to use as soon as possible within 72 hours after unprotected sex or contraceptive failure and to contact a healthcare professional if vomiting occurs within two hours. This page reports that exact U.S. label only and cannot extend it to another product, market or individual circumstance; time-sensitive uncertainty requires prompt contact with a pharmacist, clinician or local reproductive-health service." }, { "zh": "标签说明它不是常规避孕方法，也不预防 HIV/AIDS 或其他性传播感染；不得把“紧急避孕”读成终止已经存在的妊娠、日常避孕、感染防护或效果保证。", "en": "The label states that it is not regular birth control and does not protect against HIV/AIDS or other sexually transmitted infections. ‘Emergency contraception’ must not be read as ending an existing pregnancy, regular contraception, infection protection or an effectiveness guarantee." }, { "zh": "依法韦仑、利福平或某些癫痫用药可能降低效果，标签要求先询问医生或药师。请带上处方药、非处方药、草药、实际包装和完整药单共同核对；共同成分、相同 1.5 mg 或其他 OTC 商品名不证明可以自行替换。", "en": "Efavirenz, rifampin or certain seizure medicines may reduce effectiveness, and the label says to ask a doctor or pharmacist first. Review prescriptions, OTC products, herbals, actual packs and the complete medicine list together; a shared ingredient, matching 1.5 mg amount or another OTC brand does not prove self-substitutability." } ], "source": { "id": "src_df073f3c4596f4b8", "label": "DailyMed（NLM）：PLAN B ONE-STEP 当前美国 OTC Drug Facts——用途、方向、相互作用与警告", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6ce6b40e-14ac-47bd-a648-ddf9e452e559", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "作用机制阅读：紧急避孕不是终止已有妊娠", "en": "Mechanism reading: emergency contraception does not end an existing pregnancy" }, "summary": { "zh": "所引美国标签把本品用于无保护性行为或避孕失败后的紧急避孕，并明确写明不会终止已经存在的妊娠。机制与标签范围只能帮助理解产品，不能预测个人效果或替代临床判断。", "en": "The cited U.S. label describes emergency contraception after unprotected sex or contraceptive failure and explicitly states that it will not end an existing pregnancy. Mechanism and label scope help explain the product but cannot predict individual effectiveness or replace clinical judgment." }, "checks": [ { "zh": "“左炔诺孕酮”是成分身份，不代表所有含该成分的产品具有相同批准、包装、标签、时间窗口或可替代性。必须核对准确产品与目标市场说明书。", "en": "‘Levonorgestrel’ is an ingredient identity; it does not make every product with that ingredient identical in approval, pack, label, time window or interchangeability. Check the exact product and target-market label." }, { "zh": "出现明显下腹痛、疑似妊娠、月经显著延迟或其他令人担忧的表现时，应及时联系医疗服务；网页不通过机制文字诊断宫外孕、妊娠或个人风险。", "en": "Marked lower-abdominal pain, suspected pregnancy, a substantially delayed period or another concerning feature requires timely healthcare contact. The page does not diagnose ectopic pregnancy, pregnancy or individual risk from mechanism text." }, { "zh": "本页不把紧急避孕药机制扩展为常规全基因筛查建议，也不生成与 YAZ、其他口服避孕药或宫内节育器的换算、叠加或轮换方案。", "en": "This page does not extend emergency-contraception mechanism into routine whole-genome screening or generate conversion, combination or rotation plans with YAZ, another oral contraceptive or an intrauterine device." } ], "source": { "id": "src_df073f3c4596f4b8", "label": "DailyMed（NLM）：PLAN B ONE-STEP 当前美国 OTC Drug Facts——产品用途与既存妊娠边界", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6ce6b40e-14ac-47bd-a648-ddf9e452e559", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "PLAN B ONE-STEP", "generic": "左炔诺孕酮", "dosageFormClass": "PLAN B ONE-STEP 左炔诺孕酮 1.5 mg 口服片：NDC 69536-162-88，每盒 1 板、每板 1 片" }, "labelSource": { "id": "src_df073f3c4596f4b8", "label": "DailyMed（NLM）：PLAN B ONE-STEP 左炔诺孕酮当前美国 OTC 标签（2023-01-31 更新；SPL v5）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6ce6b40e-14ac-47bd-a648-ddf9e452e559", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "productRoutes": [ { "source": { "id": "src_df073f3c4596f4b8", "label": "DailyMed（NLM）：PLAN B ONE-STEP 左炔诺孕酮当前美国 OTC 标签（2023-01-31 更新；SPL v5）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6ce6b40e-14ac-47bd-a648-ddf9e452e559", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "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": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_a7233cd52f9fae69", "label": "FDA Drugs@FDA：PLAN B ONE-STEP NDA 021998 产品、RLD/RS 与审批历史", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021998", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-04", "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": "2026-09-04", "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": "PLAN B ONE-STEP 是美国 OTC 左炔诺孕酮紧急避孕药的品牌监管档案。准确零售展示面为 NDC 69536-162-88：每片含左炔诺孕酮 1.5 mg，每盒只有一板、一片。1.5 mg 是每片成分量，1 片是包装数量；网页不会由此生成个人是否适用、是否需要再次使用、如何替代或与其他避孕方法衔接的方案。", "history": "FDA Drugs@FDA 记录 NDA 021998 于 2009-07-10 原始批准，并把当前 PLAN B ONE-STEP 1.5 mg 口服片列为 OTC、RLD 与 RS。DailyMed 当前公开 OTC Drug Facts 于 2023-01-31 更新（SPL v5），列示单片、圆形白色至类白色、G00 刻印、无刻痕以及零售 NDC 69536-162-88。NDC 69536-146-19 明示仅供诊所使用、不得零售，不能作为本页零售包装展示面。", "sourceDocuments": [ { "id": "src_df073f3c4596f4b8", "label": "DailyMed（NLM）：PLAN B ONE-STEP 左炔诺孕酮当前美国 OTC 标签（2023-01-31 更新；SPL v5）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6ce6b40e-14ac-47bd-a648-ddf9e452e559", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_a7233cd52f9fae69", "label": "FDA Drugs@FDA：PLAN B ONE-STEP NDA 021998 产品、RLD/RS 与审批历史", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021998", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_3cba6889fa3fce7d", "label": "FDA：PLAN B ONE-STEP NDA 021998 原始批准函（2009-07-10）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021998s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } ], "applicationNumber": "FDA NDA 021998（PLAN B ONE-STEP；levonorgestrel 1.5 mg tablet）", "approvalTimeline": [ { "date": "2009-07-10", "title": { "zh": "FDA 原始批准 PLAN B ONE-STEP NDA 021998", "en": "FDA original approval of PLAN B ONE-STEP NDA 021998" }, "detail": { "zh": "Drugs@FDA 将 ORIG-1 列为新剂型批准，并把当前 1.5 mg 片剂列为 OTC RLD 与 RS；这是美国监管历史与参照身份，不是其他市场结论。", "en": "Drugs@FDA lists ORIG-1 as a new-dosage-form approval and the current 1.5 mg tablet as an OTC RLD and RS. This is U.S. regulatory history and reference status, not another market's conclusion." }, "source": { "id": "src_a7233cd52f9fae69", "label": "FDA Drugs@FDA：PLAN B ONE-STEP NDA 021998 产品、RLD/RS 与审批历史", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021998", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2023-01-31", "title": { "zh": "当前 DailyMed OTC Drug Facts 更新", "en": "Current DailyMed OTC Drug Facts updated" }, "detail": { "zh": "本页成分量、单片零售包装、外观、使用范围、相互作用和安全阅读以该公开标签为主要来源；标签更新时间不等于实时供应。", "en": "The ingredient amount, single-tablet retail pack, appearance, use scope, interactions and safety reading use this public label as the primary source. A label-update date is not real-time availability." }, "source": { "id": "src_df073f3c4596f4b8", "label": "DailyMed（NLM）：PLAN B ONE-STEP 当前美国 OTC 标签（SPL v5）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6ce6b40e-14ac-47bd-a648-ddf9e452e559", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "NDA 021998 当前 OTC 产品记录与公开 Drug Facts 已建立", "en": "Current OTC product record and public Drug Facts established under NDA 021998" }, "detail": { "zh": "1.5 mg 口服片在 Drugs@FDA 当前表中为 RLD 与 RS。本页记录准确标签和零售包装身份，不声明任何渠道库存、真伪或个人适用性。", "en": "The 1.5 mg oral tablet is currently listed by Drugs@FDA as an RLD and RS. This page records the exact label and retail-pack identity without claiming channel stock, authenticity or individual suitability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "现行批准、品牌、包装和使用说明待逐市场核验", "en": "Current approval, brand, pack and directions not yet established market by market" }, "detail": { "zh": "不从美国商品名、OTC 身份、NDA、RLD/RS、NDC、72 小时文字或单片包装推定当地批准、供应、可售资格或个人方案。", "en": "No local approval, supply, sale eligibility or individual plan is inferred from the U.S. brand, OTC status, NDA, RLD/RS, NDC, 72-hour wording or single-tablet pack." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "1.5 mg 和一盒 1 片分别是什么意思？", "en": "What do 1.5 mg and one tablet per carton mean?" }, "answer": { "zh": "1.5 mg 是这一准确标签产品每片含有的左炔诺孕酮量；一盒 1 片只是包装数量。二者不能相乘、拆分或改写为某个人应使用几次。", "en": "1.5 mg is the amount of levonorgestrel in each tablet of this exact labelled product; one tablet is only the carton count. The figures cannot be multiplied, split or converted into how many times an individual should use it." } }, { "question": { "zh": "它是日常避孕药或性传播感染防护吗？", "en": "Is it regular birth control or protection from sexually transmitted infections?" }, "answer": { "zh": "不是。所引美国 Drug Facts 明确写明它不是常规避孕方法，也不预防 HIV/AIDS 或其他性传播感染。个人后续避孕、暴露或感染风险应联系相应专业服务。", "en": "No. The cited U.S. Drug Facts states that it is not regular birth control and does not protect against HIV/AIDS or other sexually transmitted infections. Individual follow-on contraception, exposure or infection risk requires the appropriate professional service." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/plan-b-one-step/", "en": "https://origindrug.com/en/drugs/plan-b-one-step/" }, "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." ] }