{ "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": 65901 } }, "results": [ { "safetyreportversion": "1", "safetyreportid": "10004377", "primarysourcecountry": "GB", "occurcountry": "GB", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20140312", "fulfillexpeditecriteria": "1", "companynumb": "GB-ACTAVIS-2014-04180", "duplicate": "1", "reportduplicate": { "duplicatesource": "ACTAVIS", "duplicatenumb": "GB-ACTAVIS-2014-04180" }, "primarysource": { "reportercountry": "GB", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "24", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Hypoaesthesia oral", "reactionoutcome": "4" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Hypoaesthesia", "reactionoutcome": "4" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "IBUPROFEN (UNKNOWN)", "drugbatchnumb": "UNCONFIRMED", "drugauthorizationnumb": "74978", "drugdosagetext": "UNK", "drugdosageform": "Unk", "drugadministrationroute": "048", "drugindication": "TOOTHACHE", "drugstartdateformat": "102", "drugstartdate": "20140217", "actiondrug": "1" }, { "drugcharacterization": "2", "medicinalproduct": "AMOXICILLIN", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "TOOTH INFECTION", "drugstartdateformat": "102", "drugstartdate": "20140214", "actiondrug": "5", "drugrecurreadministration": "3", "openfda": { "application_number": [ "ANDA065255", "ANDA062216", "ANDA065271", "ANDA065256", "ANDA065322", "ANDA065319", "ANDA061926", "ANDA065056", "ANDA064013", "ANDA065119", "ANDA061931", "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": [ "0143-9285", "81964-205", "81964-225", "81964-350", "60687-776", "60687-787", "16714-298", "16714-299", "57237-028", "57237-029", "0143-9888", "0143-9889", "62135-815", "62135-082", "62135-084", "62135-085", "62135-109", "62135-088", "62135-089", "62135-090", "62135-086", "62135-087", "62135-083", "0093-2263", "0093-2264", "0093-4160", "0093-4155", "0093-4161", "0093-2267", "0093-2268", "0093-3107", "0093-3109", "65862-014", "65862-015", "0143-9939", "0781-2020", "0781-2613", "0781-5060", "0781-5061", "0781-6039", "0781-6156", "0781-6041", "0781-6157", "57237-030", "57237-031", "42571-233", "42571-234", "57237-032", "57237-033", "65862-016", "65862-017", "81964-207", "62135-824", "62135-825", "65862-070", "65862-071", "60687-798", "60687-809", "68999-824", "68999-825", "65862-706", "65862-707", "68999-083", "62135-776", "62135-777", "0143-9886", "0143-9887" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "AMOXICILLIN" ], "rxcui": [ "308194", "308182", "308191", "308192", "239191", "313797", "308189", "308177", "313850", "598025" ], "spl_id": [ "a4cd19b3-f938-4afe-9409-3bdea10deb63", "5253eb61-6d82-8057-e063-6294a90a5c84", "2f75b1e8-87b4-bd7d-e063-6294a90a0587", "3fb9b318-8cd3-46e0-bf2d-cf23f8dd58e0", "679691e2-bbbf-4ed0-a31b-e538b3df75c0", "c2fa2c99-c735-4834-a8a5-04a30da8a002", "4690e611-3a29-35ce-e063-6294a90a5e9e", "5aaabf86-b351-4834-e063-6294a90ada0c", "31223839-1653-4906-826a-f9d6af179334", "ee0e12cd-e881-4048-a0fb-74bd771cb9aa", "ed305c7b-0cf6-4dc6-b584-a68b7bd3245b", "f4681ad2-fcc2-41f6-9100-90fb4524cd28", "4e6f21c7-0e2a-4361-9549-ab42efd08d5b", "238f9a44-0678-eb7c-e063-6394a90a4c73", "62bfc65c-04fe-43b5-b659-d37067b280c0", "4dc94f3c-990d-476f-a88e-df9967570eec", "52498bbe-c0d7-4bea-e063-6394a90aafd0", "4690ed91-8da8-2e62-e063-6294a90a0ab2", "3e3ca279-1838-4348-a01c-df10a8bcb8b9", "4ee4fb77-9fd6-ea5e-e063-6394a90a0d9c", "46911108-ba5e-8cba-e063-6294a90adccc", "f4a410c9-3a78-48f9-8195-915896a974ff", "57d3f80c-e734-335f-e063-6294a90aeb3c", "4690a5fd-79cc-e1fd-e063-6294a90a009c", "606474e1-adba-4ffa-83d5-6565fc12c892" ], "spl_set_id": [ "c8591c2a-92ef-4432-b19a-bb46063047ee", "110ba6b1-f175-48a1-8e30-616c02212538", "ecb439f7-434a-4e4c-b899-943d83346f09", "843f6053-63d9-47d2-81f1-b6aa78a7c20c", "bb7733f8-6aad-4273-84a0-ef472630203f", "077f4a65-3cfb-4cb1-99f2-e27ffc5939c0", "1b9c0a98-2a31-4b23-ac4f-7c3f14b6f92f", "b07b5ac4-253e-4c83-91c3-3fdc46e91a0f", "4c0f348a-a65d-409c-8668-207c82a5e3cb", "99103779-6d2f-4e4b-9b7f-0b24d7c6bf4e", "4fb7837e-964c-4d38-a3a5-b384b1bd6e08", "13bd4214-9b7f-425b-af5f-fc1ddc678230", "bbe590a0-4196-4885-b679-cc1833af567f", "42f935ca-45ba-4b3e-8b40-9b2d4eb56281", "554239db-69fe-405a-910a-d9f9e3f8b6ed", "7e3a4517-1934-4e03-b96b-4ad65ab076c5", "06e5c07d-d95c-4955-8d35-a4703ca2359e", "5002cce4-0abc-4446-888c-47396549d4da", "3cacd754-73f4-496e-a529-9ca39fa6692d", "d339ea0f-8797-460f-a3b7-b8455c250366", "f9062321-ffb3-42e8-8f98-453cd30f5282", "234d0dfc-cb24-413f-b798-129c73eb848e", "809393b7-6271-4715-ae84-13fd8f901772", "9ce26893-c7a1-47e9-98f9-f5d998cac418", "d46f1091-33dc-4f8f-9c34-75dcfedb4b4c" ], "package_ndc": [ "0143-9285-01", "0143-9285-20", "81964-225-01", "81964-225-05", "81964-205-01", "81964-205-05", "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", "62135-084-60", "62135-084-01", "62135-085-20", "62135-085-60", "62135-085-01", "62135-109-80", "62135-109-01", "62135-109-51", "62135-088-50", "62135-088-75", "62135-088-01", "62135-089-80", "62135-089-01", "62135-089-51", "62135-090-50", "62135-090-75", "62135-090-01", "62135-086-60", "62135-086-01", "62135-087-60", "62135-087-01", "62135-082-30", "62135-082-01", "62135-082-31", "62135-083-20", "62135-083-60", "62135-083-01", "62135-083-05", "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", "68999-083-20", "68999-083-60", "68999-083-01", "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": "2", "medicinalproduct": "ORAJEL", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "5", "drugrecurreadministration": "3", "openfda": { "application_number": [ "M021" ], "brand_name": [ "ORAJEL TOY STORY 5 ANTICAVITY" ], "generic_name": [ "SODIUM FLUORIDE" ], "manufacturer_name": [ "Church & Dwight Co., Inc." ], "product_ndc": [ "10237-734" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "DENTAL" ], "substance_name": [ "SODIUM FLUORIDE" ], "rxcui": [ "416783" ], "spl_id": [ "5410dd54-fb64-fcd2-e063-6294a90aa817" ], "spl_set_id": [ "4b80947d-f389-2f80-e063-6294a90abd55" ], "package_ndc": [ "10237-734-42", "10237-734-58", "10237-734-44" ], "unii": [ "8ZYQ1474W7" ] } }, { "drugcharacterization": "2", "medicinalproduct": "PARACETAMOL", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "5", "drugrecurreadministration": "3" } ] } } ] }