Home NDC 59368-397 NDC 59368-397 - Ibuprofen This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
Product NDC 59368-397
Package NDCs from labels 59368-397-01
Manufacturer Praxis, LLC
Effective date 2023-01-01
Current FDA listing Not matched in FDA.report NDC product tables DailyMed Labels# Label, Manufacturer, Effective date table Label Manufacturer Effective date Type Ibuprofen - Praxis, LLC Praxis, LLC 2023-01-01 HUMAN OTC DRUG LABEL
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 63 of 66 · 1,308 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join basic care infants ibuprofen IBUPROFEN Amazon.com Services LLC 581dca08-a4a4-476a-a7cf-fa0f8630c777 2021-05-04 Warnings Exact identifier unii: WK2XYI10QM IBUPROFEN IBUPROFEN Aphena Pharma Solutions - Tennessee, LLC 77adb094-869c-44b4-8a4e-b739ac9cd701 2021-04-20 Exact identifier unii: WK2XYI10QM IBU IBUPROFEN Aphena Pharma Solutions - Tennessee, LLC 3e45f971-b6f7-4ec5-9d8e-1b9127b6c0bd 2021-01-21 Boxed warning, Warnings, Adverse reactions Exact identifier unii: WK2XYI10QM Sterile Water WATER Asclemed USA, Inc. 45c38269-883c-4198-a9d5-03810a4420ec 2021-01-14 Warnings, Adverse reactions Exact identifier unii: 059QF0KO0R ibuprofen IBUPROFEN Proficient Rx LP 924d2dd0-3b7d-42ec-b617-86729dba2b95 2021-01-01 Boxed warning, Warnings, Adverse reactions Exact identifier unii: WK2XYI10QM Ibuprofen IBUPROFEN Proficient Rx LP e23eb275-ce0c-40ec-b809-a48c5e46c7ec 2021-01-01 Boxed warning, Warnings, Adverse reactions Exact identifier unii: WK2XYI10QM Ibuprofen IBUPROFEN Proficient Rx LP 8813a8a4-ebbd-4204-88a3-600a92ea9170 2020-12-01 Boxed warning, Warnings, Adverse reactions Exact identifier unii: WK2XYI10QM Childrens Ibuprofen IBUPROFEN CVS Pharmacy 60fd517d-608b-473e-8a44-eb9842459997 2020-10-22 Warnings Exact identifier unii: WK2XYI10QM Ibuprofen IB IBUPROFEN WINCO FOODS, LLC 9d78644d-83c7-46d1-8156-0d76acb7c299 2020-09-17 Warnings Exact identifier unii: WK2XYI10QM Ibuprofen IB IBUPROFEN WINCO FOODS, LLC ee867519-227f-44ba-ba8b-2dbefcc9fc67 2020-09-17 Warnings Exact identifier unii: WK2XYI10QM basic care childrens ibuprofen IBUPROFEN Amazon.com Services LLC 18e5eed7-d3be-4559-93ca-b40ee26c7bd8 2020-09-09 Warnings Exact identifier unii: WK2XYI10QM Basic Care Childrens Ibuprofen IBUPROFEN Amazon.com Services LLC d53cb3f1-6689-40dd-bdea-fad3a841d482 2020-09-03 Warnings Exact identifier unii: WK2XYI10QM Dolex Children IBUPROFEN Pharmadel LLC ac3c264f-da37-a474-e053-2a95a90abdad 2020-08-06 Warnings Exact identifier unii: WK2XYI10QM Bach Original Flower Remedies WATER Nelson Bach USA Limited 09c76050-42c5-4403-865c-a1f6f668d9c0 2020-06-15 Warnings Exact identifier unii: 059QF0KO0R IBUPROFEN IBUPROFEN Bryant Ranch Prepack 6d189e86-4c36-43f5-b406-a342458d4155 2020-05-27 Exact identifier unii: WK2XYI10QM IBUPROFEN, DIPHENHYDRAMINE HCL IBUPROFEN, DIPHENHYDRAMINE HCL Rite Aid Corporation a35f68f3-c7f8-a55f-e053-2a95a90a9047 2020-04-15 Warnings Exact identifier unii: WK2XYI10QM childrens ibuprofen IBUPROFEN Rite Aid Corporation af68a4bf-bc49-40c7-812d-035eff474ed9 2020-04-03 Warnings Exact identifier unii: WK2XYI10QM JUNIOR STRENGTH ADVIL IBUPROFEN Proficient Rx LP 91fc4794-1880-460f-86dd-49d8c1e872bc 2020-03-01 Warnings Exact identifier unii: WK2XYI10QM ibuprofen IBUPROFEN Proficient Rx LP 6d84ed87-b643-46e2-96d4-2052f41bd936 2020-02-01 Warnings Exact identifier unii: WK2XYI10QM Ibuprofen IBUPROFEN PURACAP PHARMACEUTICAL LLC 9e86b6e5-5374-4699-a0d1-a4c3d069f262 2020-01-17 Warnings Exact identifier unii: WK2XYI10QM
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.