{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-07-30", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "safetyreportversion": "1", "safetyreportid": "24238563", "primarysourcecountry": "ES", "occurcountry": "ES", "transmissiondateformat": "102", "transmissiondate": "20241017", "reporttype": "1", "serious": "1", "seriousnessdeath": "1", "seriousnesslifethreatening": "2", "seriousnesshospitalization": "2", "seriousnessdisabling": "2", "seriousnesscongenitalanomali": "2", "seriousnessother": "2", "receivedateformat": "102", "receivedate": "20240822", "receiptdateformat": "102", "receiptdate": "20240822", "fulfillexpeditecriteria": "1", "authoritynumb": "ES-AEMPS-1557509", "duplicate": "1", "reportduplicate": { "duplicatesource": "AGEMED", "duplicatenumb": "ES-AEMPS-1557509" }, "primarysource": { "reportercountry": "ES", "qualification": "1" }, "sender": { "sendertype": "1", "senderorganization": "TEVA" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "1", "patientonsetageunit": "805", "patientweight": "3", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Hypoplastic left heart syndrome", "reactionoutcome": "5" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Foetal exposure during pregnancy", "reactionoutcome": "5" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "AMOXICILLIN", "drugbatchnumb": "UNKNOWN", "drugauthorizationnumb": "61926", "drugstructuredosagenumb": "750", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "8", "drugintervaldosagedefinition": "805", "drugdosagetext": "AMOXICILINA (108A)", "drugadministrationroute": "064", "drugindication": "Respiratory tract infection", "drugstartdateformat": "102", "drugstartdate": "20230130", "drugenddateformat": "102", "drugenddate": "20230204", "drugtreatmentduration": "6", "drugtreatmentdurationunit": "804", "actiondrug": "1", "activesubstance": { "activesubstancename": "AMOXICILLIN" }, "openfda": { "application_number": [ "ANDA065255", "ANDA062216", "ANDA065271", "ANDA065256", "ANDA065322", "ANDA065319", "ANDA065056", "ANDA064013", "ANDA061926", "ANDA061931", "ANDA065119", "ANDA065291", "ANDA064076", "ANDA065228", "ANDA065387", "ANDA065378", "ANDA207471", "ANDA065334", "NDA050760", "ANDA062058", "ANDA204030", "ANDA062059", "ANDA065325" ], "brand_name": [ "AMOXICILLIN" ], "generic_name": [ "AMOXICILLIN" ], "manufacturer_name": [ "Hikma Pharmaceuticals USA Inc.", "USAntibiotics, LLC", "American Health Packaging", "NorthStar Rx LLC", "Rising Pharma Holdings, Inc.", "Chartwell RX, LLC", "Teva Pharmaceuticals USA, Inc.", "Aurobindo Pharma Limited", "Sandoz Inc", "Micro Labs Limited", "Chartwell Governmental & Specialty RX, LLC" ], "product_ndc": 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"81964-205-10", "81964-205-60", "81964-350-98", "81964-350-10", "81964-350-60", "60687-776-11", "60687-776-01", "60687-787-11", "60687-787-01", "16714-298-01", "16714-298-02", "16714-299-01", "16714-299-02", "16714-299-03", "16714-299-04", "57237-028-20", "57237-028-01", "57237-029-20", "57237-029-01", "0143-9888-80", "0143-9888-01", "0143-9888-15", "0143-9889-80", "0143-9889-01", "0143-9889-15", "62135-815-42", "0093-2263-01", "0093-2264-01", "0093-4160-76", "0093-4160-78", "0093-4160-73", "0093-4155-79", "0093-4155-73", "0093-4155-80", "0093-4161-76", "0093-4161-78", "0093-4161-73", "0093-2267-01", "0093-2268-01", "0093-3107-01", "0093-3107-05", "0093-3109-53", "0093-3109-05", "65862-014-20", "65862-014-01", "65862-014-05", "65862-015-20", "65862-015-01", "65862-015-05", "0143-9939-05", "0143-9939-28", "0781-2020-31", "0781-2020-76", "0781-2020-01", "0781-2020-05", "0781-2613-31", "0781-2613-76", "0781-2613-01", "0781-2613-05", "0781-5060-20", "0781-5060-01", "0781-5061-20", "0781-5061-01", "0781-6039-58", "0781-6039-46", "0781-6039-55", "0781-6156-52", "0781-6156-57", "0781-6156-46", "0781-6041-58", "0781-6041-46", "0781-6041-55", "0781-6157-52", "0781-6157-57", "0781-6157-46", "57237-030-01", "57237-030-05", "57237-031-01", "57237-031-05", "42571-233-30", "42571-233-01", "42571-233-05", "42571-233-10", "42571-234-30", "42571-234-01", "42571-234-05", "42571-234-10", "57237-032-50", "57237-032-75", "57237-032-01", "57237-033-50", "57237-033-75", "57237-033-01", "65862-016-20", "65862-016-30", "65862-016-50", "65862-016-01", "65862-016-05", "65862-017-20", "65862-017-30", "65862-017-50", "65862-017-01", "65862-017-05", "81964-207-50", "81964-207-51", "81964-207-52", "62135-824-01", "62135-824-05", "62135-825-60", "62135-825-05", "65862-070-50", "65862-070-75", "65862-070-01", "65862-071-50", "65862-071-75", "65862-071-01", "60687-798-95", "60687-798-25", "60687-809-18", "60687-809-28", "68999-824-01", "68999-825-60", "68999-825-01", "65862-706-80", "65862-706-01", "65862-706-55", "65862-707-80", "65862-707-01", "65862-707-55", "62135-777-68", "62135-777-42", "62135-777-38", "62135-776-68", "62135-776-42", "62135-776-38", "0143-9886-01", "0143-9886-50", "0143-9886-75", "0143-9887-01", "0143-9887-50", "0143-9887-75" ], "unii": [ "804826J2HU" ] } }, { "drugcharacterization": "1", "medicinalproduct": "CHLORINE DIOXIDE", "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": "10", "drugstructuredosageunit": "012", "drugseparatedosagenumb": "1", "drugcumulativedosagenumb": "10", "drugcumulativedosageunit": "012", "drugdosagetext": "TIME INTERVAL: TOTAL: CHLORINE DIOXIDE (OTHER)", "drugadministrationroute": "064", "drugindication": "Respiratory tract infection", "drugstartdateformat": "102", "drugstartdate": "20230130", "drugenddateformat": "102", "drugenddate": "20230130", "drugtreatmentduration": "1", "drugtreatmentdurationunit": "804", "actiondrug": "1", "activesubstance": { "activesubstancename": "CHLORINE DIOXIDE" }, "openfda": { "brand_name": [ "PURE O2-S F" ], "generic_name": [ "CHLORINE DIOXIDE" ], "manufacturer_name": [ "Pure O2" ], "product_ndc": [ "75124-0014", "75124-0001" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "TOPICAL" ], "substance_name": [ "CHLORINE DIOXIDE" ], "spl_id": [ "33e25ea9-f6c4-787b-e063-6294a90a3fad", "adfeccac-a851-8cb6-e053-2995a90ac488" ], "spl_set_id": [ "33e26932-15f7-8304-e063-6294a90a7324", "a390128a-0331-0afa-e053-2a95a90a97bc" ], "package_ndc": [ "75124-0014-1", "75124-0001-1" ], "unii": [ "8061YMS4RM" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20230130" } } } ] }