{
  "id": "flonase-allergy-relief",
  "recordTier": "source_traceable_archive",
  "editorial": {
    "reviewedAt": "2026-08-17",
    "status": "published_traceable_archive"
  },
  "names": {
    "brand": "Flonase Allergy Relief",
    "generic": "丙酸氟替卡松",
    "aliases": [
      "辅舒良",
      "fluticasone propionate",
      "fluticasone propionate nasal spray"
    ],
    "marketBrandNames": [],
    "mainlandChinaTradeNameCue": null
  },
  "identity": {
    "therapeuticArea": "呼吸系统",
    "sourceArchiveMarket": "美国 OTC 公开标签档案",
    "dosageFormClass": "定量鼻喷雾剂（本档案限定为每喷 50 mcg 丙酸氟替卡松）",
    "dosageFormClassCode": "other",
    "route": "鼻腔给药",
    "routeCode": "other",
    "historicalApprovalEntry": "未在本页推定（应按目标市场官方记录核验）",
    "archiveSponsorText": "DailyMed（NLM）公开标签档案"
  },
  "matchPolicy": {
    "contract": "reviewed_name_and_exclusion_cues_v1",
    "exactMatchNames": [],
    "excludedProductCues": [],
    "exclusionPrecedence": "before_name_candidate"
  },
  "productPresentations": [
    {
      "id": "us-flonase-allergy-relief-fluticasone-propionate-50mcg-spray-144-metered-sprays",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国 OTC 公开标签（2024-12-19 更新）",
        "en": "Current U.S. DailyMed public OTC label (updated 19 Dec 2024)"
      },
      "dosageForm": {
        "zh": "FLONASE Allergy Relief 丙酸氟替卡松定量鼻喷雾剂",
        "en": "FLONASE Allergy Relief fluticasone propionate metered nasal spray"
      },
      "route": {
        "zh": "鼻腔给药（标签产品身份字段）",
        "en": "nasal (label product-identity field)"
      },
      "routeCodes": [
        "nasal"
      ],
      "productCode": "NDC 0135-0576",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_metered_nasal_spray",
      "primaryDisplay": {
        "zh": "每次定量喷射含丙酸氟替卡松 50 mcg；144 次定量喷射；净含量 18.2 mL",
        "en": "Fluticasone propionate 50 mcg per metered spray; 144 metered sprays; 18.2 mL"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Flonase+Allergy+144+sprays.jpg&setid=b6134ba0-b70a-4eac-9a82-cef64b242c1d&type=img",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "丙酸氟替卡松（每次定量喷射）",
            "en": "fluticasone propionate (per metered spray)"
          },
          "value": 50,
          "unit": "mcg",
          "basisCode": "per_metered_nasal_spray",
          "basisLabel": {
            "zh": "每喷标签标示量；不是个人每次或每日喷数",
            "en": "labelled amount per spray; not an individual's spray count or daily plan"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "metered_nasal_spray_bottle",
        "typeLabel": {
          "zh": "定量鼻喷雾瓶",
          "en": "metered nasal spray bottle"
        },
        "fill": {
          "value": 18.2,
          "unit": "mL"
        },
        "countPerPackage": null,
        "countUnit": null
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-08-28",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "not_established",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 144,
        "unit": {
          "zh": "次定量喷射/瓶",
          "en": "metered sprays per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "DailyMed 144 喷包装展示面",
          "en": "DailyMed 144-spray package display"
        },
        "shape": {
          "zh": "带定量喷雾泵的鼻喷雾瓶及纸盒",
          "en": "nasal spray bottle with metered pump and carton"
        },
        "imprint": null,
        "scoreStatus": null,
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_3341ee053e42bbb9",
        "label": "DailyMed（NLM）：FLONASE Allergy Relief 丙酸氟替卡松鼻喷雾剂当前美国 OTC 公开标签（2024-12-19 更新）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b6134ba0-b70a-4eac-9a82-cef64b242c1d",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "publication_status_unresolved",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-20",
        "reviewedAt": "2026-08-20"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    }
  ],
  "comparisonPresentations": [],
  "appearanceReferences": [],
  "visualReference": {
    "presentationId": null,
    "status": "historical_public_label_image_not_product_authentication",
    "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Flonase+Allergy+144+sprays.jpg&setid=b6134ba0-b70a-4eac-9a82-cef64b242c1d&type=img",
    "alt": "FLONASE Allergy Relief 丙酸氟替卡松鼻喷雾剂在美国 DailyMed Haleon 公开标签中的 144 喷装包装图",
    "archiveMarket": "美国",
    "labelVersion": "DailyMed 公开标签（Haleon US Holdings，2024-12 更新）",
    "presentation": "FLONASE Allergy Relief 丙酸氟替卡松鼻喷雾剂、每喷 50 mcg、144 喷装包装图（DailyMed Haleon US Holdings 公开标签所列）。",
    "notice": "此为美国 DailyMed Haleon US Holdings 公开标签中对应 FLONASE Allergy Relief、每喷 50 mcg、144 喷装的包装图，只帮助核对品牌、通用名、鼻喷雾剂、标示量、喷数和来源；不用于鉴定真伪，也不证明其他喷数、其他装置、其他市场标签、当前可得性、原研身份、目标市场批准或可售资格。",
    "source": {
      "id": "src_3341ee053e42bbb9",
      "label": "DailyMed（NLM）：FLONASE Allergy Relief 公开标签（Haleon US Holdings，2024-12 更新）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b6134ba0-b70a-4eac-9a82-cef64b242c1d",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "publication_status_unresolved",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-08-20",
      "reviewedAt": "2026-08-20"
    }
  },
  "visualCoverageNote": null,
  "labelReading": {
    "coverage": "drug_specific_source_review",
    "title": {
      "zh": "FLONASE 说明书放大阅读：每喷 50 mcg 与“仅供鼻腔使用”要一起核对",
      "en": "FLONASE label reading: read 50 mcg per spray together with “for nasal use only”"
    },
    "summary": {
      "zh": "本模块以美国 DailyMed 公开标签为阅读入口，帮助核对 FLONASE ALLERGY RELIEF、丙酸氟替卡松、每喷 50 mcg、定量鼻喷雾剂及鼻腔给药途径。它不提供个人喷次、疗程、换产品或与其他激素产品联用的方案。",
      "en": "This module uses the U.S. DailyMed public label to check FLONASE ALLERGY RELIEF, fluticasone propionate, 50 mcg per spray, metered nasal-spray form and nasal route. It does not provide an individual spray count, course, product switch or plan for combining with another steroid product."
    },
    "checks": [
      {
        "zh": "先将 FLONASE ALLERGY RELIEF、丙酸氟替卡松、每喷 50 mcg、定量鼻喷雾剂和鼻腔给药途径一起核对。50 mcg/喷描述这一个喷雾产品的标示单位，不是网页给任何人的喷次指令。",
        "en": "Check FLONASE ALLERGY RELIEF, fluticasone propionate, 50 mcg per spray, metered nasal-spray form and nasal route together. 50 mcg/spray describes the labelled unit of this spray, not a web instruction for anyone's spray count."
      },
      {
        "zh": "标签明确“仅供鼻腔使用”，并提示不要喷入眼睛或口腔。它不能被当作口服、眼用、皮肤用、肺部吸入或另一种鼻喷雾产品的替代品；共同名称片段或“激素”描述不足以证明可换用。",
        "en": "The label states “for nasal use only” and warns not to spray into the eyes or mouth. It is not a substitute for oral, eye, skin, lung-inhaled or another nasal-spray product; a shared name fragment or “steroid” wording does not establish exchangeability."
      },
      {
        "zh": "标签提示正在使用 HIV 治疗药物或其他用于哮喘、过敏或皮疹的激素药时要向医生或药师询问。请带上全部处方药、非处方药、吸入器、喷雾和外用产品核对，而不是只看其中一个药盒。",
        "en": "The label directs readers using HIV medicines or another steroid medicine for asthma, allergies or skin rash to ask a clinician or pharmacist. Bring all prescription, OTC, inhaler, spray and topical products for review rather than looking at one package alone."
      },
      {
        "zh": "鼻部受伤/手术未愈合、眼部问题、异常不适或疑似过敏反应都不适合从网页自行决定继续、暂停或换用。包装图片和名称也不能验证真伪或当前批准状态。",
        "en": "A not-yet-healed nasal injury/surgery, eye problems, unusual symptoms or a suspected reaction are not situations for self-deciding continuation, pause or switching from a webpage. Package images and names also cannot authenticate a product or establish current approval."
      }
    ],
    "source": {
      "id": "src_3341ee053e42bbb9",
      "label": "DailyMed（NLM）：FLONASE ALLERGY RELIEF 丙酸氟替卡松定量鼻喷雾剂公开标签（Haleon，2024-12 更新）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b6134ba0-b70a-4eac-9a82-cef64b242c1d",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "publication_status_unresolved",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-08-20",
      "reviewedAt": "2026-08-20"
    },
    "scope": "label_literacy_only_no_individual_dosing_or_substitution"
  },
  "mechanismReading": {
    "title": {
      "zh": "丙酸氟替卡松怎样被标签归类：糖皮质激素说明产品类别，不代替使用判断",
      "en": "How fluticasone propionate is classified on the label: “glucocorticoid” describes a class, not a use decision"
    },
    "summary": {
      "zh": "美国 DailyMed 标签把本产品中的丙酸氟替卡松标为糖皮质激素，并把产品定位为过敏症状缓解药。这个类别说明必须与准确的鼻喷雾剂型、每喷标示和目标市场一起阅读；它不是个人适用性、喷次或与其他激素产品联用的结论。",
      "en": "The U.S. DailyMed label identifies fluticasone propionate in this product as a glucocorticoid and presents it as an allergy-symptom reliever. This class must be read with the exact nasal-spray form, per-spray wording and target market; it is not a conclusion about individual suitability, spray count or combination with another steroid product."
    },
    "checks": [
      {
        "zh": "“糖皮质激素”是药物类别，不等于所有写有“激素”的药可自行互换、合用或按强度数字换算。鼻喷雾、吸入、皮肤外用、口服或注射产品的途径和标签边界不同。",
        "en": "“Glucocorticoid” is a drug class; it does not make every product labelled a “steroid” self-interchangeable, combinable or convertible by strength numbers. Nasal sprays, inhaled, topical, oral and injected products have different routes and label boundaries."
      },
      {
        "zh": "类别和症状文字不能自行判断鼻塞、眼痒、咳嗽或呼吸困难的原因，也不能代替目标市场的现行标签与诊断。",
        "en": "Class and symptom wording cannot self-diagnose the cause of congestion, itchy eyes, cough or breathing difficulty, and cannot replace the current target-market label and diagnosis."
      },
      {
        "zh": "如果家中同时有多种鼻喷雾、吸入器、皮肤药或复方感冒药，完整药单比“都叫过敏药”更重要。让药师或医生核对实际产品，而不是根据本页自行调整。",
        "en": "If several nasal sprays, inhalers, skin products or combination cold medicines are at home, the complete medicine list matters more than calling them all “allergy medicines.” Have a pharmacist or clinician check the actual products rather than self-adjusting from this page."
      }
    ],
    "source": {
      "id": "src_3341ee053e42bbb9",
      "label": "DailyMed（NLM）：FLONASE ALLERGY RELIEF 丙酸氟替卡松定量鼻喷雾剂公开标签（Haleon，2024-12 更新）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b6134ba0-b70a-4eac-9a82-cef64b242c1d",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "publication_status_unresolved",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-08-20",
      "reviewedAt": "2026-08-20"
    },
    "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution"
  },
  "pharmacovigilance": {
    "status": "official_routes_only_no_live_alert_inference",
    "reviewedAt": "2026-08-22",
    "identity": {
      "brand": "Flonase Allergy Relief",
      "generic": "丙酸氟替卡松",
      "dosageFormClass": "定量鼻喷雾剂（本档案限定为每喷 50 mcg 丙酸氟替卡松）"
    },
    "labelSource": {
      "id": "src_3341ee053e42bbb9",
      "label": "DailyMed（NLM）：FLONASE ALLERGY RELIEF 丙酸氟替卡松定量鼻喷雾剂公开标签（Haleon，2024-12 更新）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b6134ba0-b70a-4eac-9a82-cef64b242c1d",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "publication_status_unresolved",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-08-20",
      "reviewedAt": "2026-08-20"
    },
    "productRoutes": [
      {
        "source": {
          "id": "src_3341ee053e42bbb9",
          "label": "DailyMed（NLM）：FLONASE ALLERGY RELIEF 丙酸氟替卡松定量鼻喷雾剂公开标签（Haleon，2024-12 更新）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b6134ba0-b70a-4eac-9a82-cef64b242c1d",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "publication_status_unresolved",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-20",
          "reviewedAt": "2026-08-20"
        },
        "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": "2026-08-20",
        "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": "2026-08-20",
      "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": "DailyMed 的 FLONASE ALLERGY RELIEF（fluticasone propionate）美国 OTC 公开标签将本档案所列产品标示为每喷 50 mcg 的定量鼻喷雾剂，并注明仅供鼻腔使用。页面用于阅读名称、成分、每喷标示、鼻腔给药途径和标签边界；不推定其他市场的批准、包装、原研关系、供应或可售资格。",
    "history": "“鼻喷雾”“每喷”和“每 mL/每片”等不是同一单位，也不是可在网页上互相换算的产品。不同氟替卡松化合物、不同喷雾器和其他吸入/外用产品必须逐项核对。",
    "sourceDocuments": [
      {
        "id": "src_3341ee053e42bbb9",
        "label": "DailyMed（NLM）：FLONASE ALLERGY RELIEF 丙酸氟替卡松定量鼻喷雾剂公开标签（Haleon，2024-12 更新）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b6134ba0-b70a-4eac-9a82-cef64b242c1d",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "publication_status_unresolved",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-20",
        "reviewedAt": "2026-08-20"
      },
      {
        "id": "src_5ed30b676fbb9773",
        "label": "FDA Drugs@FDA 官方检索入口",
        "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": "2024-12",
        "title": {
          "zh": "DailyMed 公开标签版本",
          "en": "DailyMed public label version"
        },
        "detail": {
          "zh": "本页链接 2024-12 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 2024-12 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_3341ee053e42bbb9",
          "label": "DailyMed: FLONASE ALLERGY RELIEF public OTC label",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b6134ba0-b70a-4eac-9a82-cef64b242c1d",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "publication_status_unresolved",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-20",
          "reviewedAt": "2026-08-20"
        }
      }
    ],
    "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/flonase-allergy-relief/",
    "en": "https://origindrug.com/en/drugs/flonase-allergy-relief/"
  },
  "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."
  ]
}