FDA.reportPublic FDA data

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
LabelManufacturerEffective dateType
Ibuprofen - Praxis, LLCPraxis, LLC2023-01-01HUMAN 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 49 of 66 · 1,308 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENNuCare Pharmaceuticals,Inc.a2160213-2a32-2044-e053-2995a90a21af2024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFEN 200MGLil' Drug Store Products, Inc.8fc65767-1783-4f7f-8680-9e43ba4d54812024-06-19WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENNuCare Pharmaceuticals,Inc.8c3dccbb-1084-cd09-e053-2a95a90ac12a2024-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENNuCare Pharmaceuticals,Inc.8cb93e5f-4ebc-24b7-e053-2a95a90a5a232024-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
IbuprofenIBUPROFENNuCare Pharmaceuticals,Inc.88795f0e-41b7-504e-e053-2995a90a3b9e2024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Ibuprofen, Circle K, 50ctIBUPROFENLil' Drug Store Products, Inc.1ab6fbae-ead5-283b-e063-6394a90a4ed42024-06-12WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENTrifecta Pharmaceuticals USA LLC114b5e23-6cd7-41d8-e063-6294a90aa0f02024-06-12WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENNuCare Pharmaceuticals,Inc.6d86ce94-a06a-2769-e053-2991aa0afb952024-06-10Exact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENNuCare Pharmaceuticals,Inc.6365b2d6-2337-70c0-e053-2a91aa0aa9602024-06-06Exact identifier
unii: WK2XYI10QM
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
IbuprofenIBUPROFENBoswell Pharmacy Services LLC d/b/a BPS Wholesale1a02fa34-b5ae-7183-e063-6294a90a3ae42024-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ibuprofenIBUPROFENSKYA HEALTH, LLC1c28af16-7246-4e4c-a1be-939655c372422024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENSAM'S WEST INC16595d75-6e74-0839-e063-6394a90abc132024-05-28WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen, Lil Drug StoreIBUPROFENLil' Drug Store products, Inc.18e80dab-6837-fd2d-e063-6294a90a73c82024-05-20WarningsExact identifier
unii: WK2XYI10QM
IBUPROFEN 100IBUPROFENJHK Inc dba American Safety & First Aid218f6df9-dd04-45b6-8a45-3276691abee22024-04-25WarningsExact identifier
unii: WK2XYI10QM
ADVIL DUAL ACTION WITH ACETAMINOPHEN Back PainIBUPROFEN, ACETAMINOPHENHaleon US Holdings LLCacaa9806-e552-44f2-a680-b8bb64c49e1f2024-04-24WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen 200 mg and Diphenhydramine Citrate 38 mgIBUPROFEN, DIPHENHYDRAMINE CITRATEPLD Acquisitions LLC DBA Avma Pharma Solutionsa7d729bf-6d7a-415a-a414-cae0ba6d00632024-04-24WarningsExact identifier
unii: WK2XYI10QM
IBUPROFEN AND FAMOTIDINEIBUPROFEN AND FAMOTIDINEAdvanced Rx Pharmacy of Tennessee, LLC16c8b0db-37d0-99d9-e063-6394a90ac31b2024-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.