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 44 of 66 · 1,308 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENWinco Foods, LLC428b011f-d7d3-4a3b-87dd-d4e84e90cabd2024-12-06WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENWinco Foods, LLC61cd9140-eded-4bcf-894b-a163fa5f3e102024-12-06WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENWinco Foods, LLC60130bdc-6f45-4998-b53a-cad6cbf250362024-12-06WarningsExact identifier
unii: WK2XYI10QM
PROPRINALIBUPROFEN CAPSULES 200 MGHART Healthec27b625-a3fa-4c5f-8134-c9373c09b3e32024-12-04WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENSOLA Pharmaceuticals, LLCb19b8c34-e0c1-4982-92fc-34dbe73849352024-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENH E Ba340ed68-debb-4c1e-97eb-82f6e9e3854f2024-12-02WarningsExact identifier
unii: WK2XYI10QM
Advil PM, TRAVEL BASIXIBUPROFEN AND DIPHENHYDRAMINE CITRATELil' Drug Store Products, Inc.b876bb40-a38b-445a-bc8a-466b3bfe166d2024-11-27WarningsExact identifier
unii: WK2XYI10QM
PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3%PURIFIED WATER 98.3%Acme United Corporation9248ee71-2d47-620d-e053-2995a90af5c82024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationcca454e0-b2bd-4215-bc06-426fcc3f7bd62024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationd3812fa3-9334-464d-b50c-98548ff767272024-11-26WarningsExact identifier
unii: 059QF0KO0R
DANGTTEOLMINERAL WATERAQBC CO., LTD27db14a9-3812-433f-e063-6394a90a11e72024-11-26WarningsExact identifier
unii: 059QF0KO0R
365 whole foods market ibuprofenIBUPROFENWhole Foods Market, INC.e914472b-c785-4c73-b37c-4d459166cf412024-11-26WarningsExact identifier
unii: WK2XYI10QM
INFANTS ADVILIBUPROFENHaleon US Holdings LLCdb5ed801-7a7e-3c83-0172-77f914daaa5a2024-11-26WarningsExact identifier
unii: WK2XYI10QM
COMBOGESIC IVACETAMINOPHEN AND IBUPROFEN INJECTIONHikma Pharmaceuticals USA Inc.be408a5a-48e4-43c0-9cb1-bbf830b54f5b2024-11-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEStrategic Sourcing Services LLCd93ae778-e6e9-4d1d-8f46-c04d962a93932024-11-22WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAdvanced Rx of Tennessee, LLC1ef5693b-d00a-28fb-e063-6294a90a7ede2024-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENTIME CAP LABORATORIES, INCec3e8443-d742-4c25-8516-f0df4ebfccdc2024-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Leader Ibuprofen PMDIPHENHYDRAMINE CITRATE, IBUPROFENCardinal Health 110, LLC. dba Leaderb19ad305-4464-4404-a011-584fa0c085212024-11-21WarningsExact identifier
unii: WK2XYI10QM
dg health ibuprofenIBUPROFENDolgencorp, LLCfd27d4e1-8edf-4bc3-a593-6be5c3345ed02024-11-13WarningsExact identifier
unii: WK2XYI10QM
Childrens MotrinIBUPROFENKenvue Brands LLC4f664479-f68c-464a-956d-25bb9f39c4cc2024-11-08WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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