FDA.reportPublic FDA data

NDC 59368-394 - 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
59368-394
Package NDCs from labels
59368-394-01
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 50 of 66 · 1,302 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dg health ibuprofenIBUPROFENDolgencorp Incb514b589-d965-4a21-91b3-fab4019e9d962024-04-12WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENH E Be00acbc0-352e-4ba1-8433-18a3079f67432024-04-12WarningsExact identifier
unii: WK2XYI10QM
Sterile WaterWATERHikma Pharmaceuticals USA Inc.78ef7ad3-451d-43d0-a9b6-5cf0aadca0032024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Infants IbuprofenIBUPROFENAurohealth LLC2a48af51-23e2-4fec-a76b-eef1611750f52024-04-10WarningsExact identifier
unii: WK2XYI10QM
Sterile WaterWATERB. Braun Medical Inc.8fc8d87a-3951-4ac5-97df-c161ffc904752024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ADVIL PMDIPHENHYDRAMINE CITRATE AND IBUPROFENHaleon US Holdings LLC658fc201-47c9-6a6d-8af9-6208298d43b42024-04-08WarningsExact identifier
unii: WK2XYI10QM
Eye WashWATERM-star (Hubei) Health&Care Products Co., Ltd.71706039-e250-4f08-9687-71b2928c4e462024-04-01WarningsExact identifier
unii: 059QF0KO0R
IbuprofenIBUPROFENSam's West, Inc74ad11b9-8976-463d-89a3-2b9f5acd0c802024-04-01WarningsExact identifier
unii: WK2XYI10QM
Dual Action Pain ReliefDUAL ACTION PAIN RELIEFAllegiant Healthfb4fc347-0f90-429f-9ca8-903e736f54962024-03-29WarningsExact identifier
unii: WK2XYI10QM
Advil Liqui-GelsIBUPROFENLil Drug Store Products, Incba5a9a04-993e-4fd6-bb40-6edfdfb69b342024-03-27WarningsExact identifier
unii: WK2XYI10QM
Infants IbuprofenINFANTS IBUPROFENFamily Dollar Services, Inc.13143eb6-2fe8-487b-e063-6294a90a967e2024-03-27WarningsExact identifier
unii: WK2XYI10QM
ULINE EyewashEYEWASHUline.14545fc9-1fb4-befa-e063-6294a90a04742024-03-23WarningsExact identifier
unii: 059QF0KO0R
IbuprofenIBUPROFENNuCare Pharmaceuticals,Inc.141b7964-cce6-74e4-e063-6294a90af7462024-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Good Sense Dual Action Back PainACETAMINOPHEN, IBUPROFENL. Perrigo Company89476188-cf88-4184-a366-ed4c2e7db1452024-03-19WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENEXELAN PHARMACEUTICALS, INC.362f934a-4382-43bc-bedd-65081286f1c92024-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENWALGREENS746f79aa-3036-1b9b-e053-2a91aa0a1db62024-03-18WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENWALGREENS76f4cc25-a77e-6245-e053-2a91aa0af7ae2024-03-18WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENWALGREENS3ce5b71b-f841-444f-bf66-023e4bd9aa162024-03-15WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENWALGREENS76f15be2-4682-5015-e053-2991aa0af0d22024-03-15WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen OralIBUPROFEN ORALBryant Ranch Prepackcf22da7e-fcf1-49da-8314-277d31199c1c2024-03-13WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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