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 25 of 66 · 1,308 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENARMY AND AIR FORCE EXCHANGE SERVICEbf7d0929-a7d5-4164-9c24-566eddcd64892025-11-15WarningsExact identifier
unii: WK2XYI10QM
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R
IbuprofenIBUPROFENP & L Development, LLCce215099-91b0-43fd-8ac9-17fe6508842c2025-11-11WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENDolgencorp, Inc. (DOLLAR GENERAL & REXALL)da9d0301-ec14-40c5-b0b9-17096913a8492025-11-11WarningsExact identifier
unii: WK2XYI10QM
GOODNOW PAIN RELIEFIBUPROFENGobrands, Inc0759085d-6ac3-446b-ac2c-8dc30e32e1d12025-11-08WarningsExact identifier
unii: WK2XYI10QM
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
childrens ibuprofenIBUPROFENKroger Company96c955b1-3139-4b12-b584-83804bc1ca6b2025-11-03WarningsExact identifier
unii: WK2XYI10QM
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Physicians Care IbuprofenIBUPROFEN 200MGAcme United Corporation490c1109-dad7-4135-e054-00144ff8d46c2025-10-31WarningsExact identifier
unii: WK2XYI10QM
Physicians Care IbuprofenIBUPROFEN 200MGAcme United Corporation490e551c-0e80-3d95-e054-00144ff8d46c2025-10-31WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENNuCare Pharmaceuticals,Inc.f60445d3-807e-0bbf-e053-2995a90a12992025-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 506T60A25R
KOSHER MEDSIBUPROFENMollec Incc9c31326-6a19-9a9c-e053-2a95a90aed062025-10-29WarningsExact identifier
unii: WK2XYI10QM
Kosher Meds Dye-Free IbuprofenIBUPROFENMollec Incba1a0bc2-0a28-4d73-9667-5a220b806e872025-10-29WarningsExact identifier
unii: WK2XYI10QM
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Up and Up Childrens IbuprofenIBUPROFENTarget Corporation17b3ca97-1bd6-4e76-a47f-2e35ef36b7072025-10-28WarningsExact identifier
unii: WK2XYI10QM
childrens ibuprofen 100IBUPROFENWalgreen Company7b798146-393f-422c-87f0-0bf800df0c712025-10-28WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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