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 38 of 66 · 1,308 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ADVIL DUAL ACTION WITH ACETAMINOPHENIBUPROFEN, ACETAMINOPHENHaleon US Holdings LLCf5ea858e-76d9-4777-b3dc-5d614f66d4852025-04-21WarningsExact identifier
unii: WK2XYI10QM
good sense ibuprofen pmDIPHENHYDRAMINE CITRATE, IBUPROFENL. Perrigo Company0488786f-9b6b-4935-bb57-bcb2565447f82025-04-21WarningsExact identifier
unii: WK2XYI10QM
Topcare Ibuprofen PMDIPHENHYDRAMINE CITRATE AND IBUPROFENTopco Associates LLC1435e627-144e-4dc8-9ad6-58d91cbd90942025-04-21WarningsExact identifier
unii: WK2XYI10QM
equaline ibuprofen pmDIPHENHYDRAMINE CITRATE, IBUPROFENUnited Natural Foods, Inc. dba UNFI5c4ff82a-bdc4-4df5-9df7-abc6becf4f4d2025-04-21WarningsExact identifier
unii: WK2XYI10QM
Exchange Select Ibuprofen PMDIPHENHYDRAMINE CITRATE, IBUPROFENArmy & Air Force Exchange Service56761c01-48f2-4d17-a607-6639fb3a7a982025-04-21WarningsExact identifier
unii: WK2XYI10QM
Equaline IbuprofenIBUPROFENUnited Natural Foods, Inc. dba UNFI5e860059-afc8-419e-9451-b1c2265f5ce62025-04-18WarningsExact identifier
unii: WK2XYI10QM
Leader IbuprofenIBUPROFENCardinal Health 110, LLC. dba Leadera5701486-0a5f-4645-91ef-1fbf525c84dd2025-04-18WarningsExact identifier
unii: WK2XYI10QM
childrens ibuprofenIBUPROFENMeijer Distribution Inc02681a10-eb8a-457f-8aff-12e6f29079de2025-04-18WarningsExact identifier
unii: WK2XYI10QM
Good Neighbor Pharmacy ibuprofen childrensIBUPROFENAmerisource Bergen43b8e61b-3ac4-4a41-b682-67d08b212cc62025-04-18WarningsExact identifier
unii: WK2XYI10QM
Good Sense IbuprofenIBUPROFENL. Perrigo Company1a6b42be-c0c2-48f8-9ba3-22d1f0c0b18d2025-04-18WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAllegiant Health2ea039d6-f522-4103-a1f9-5b80a3b12a272025-04-14WarningsExact identifier
unii: WK2XYI10QM
up and up ibuprofenIBUPROFENTarget Corporation2919fe8b-9c76-4ef6-851e-3247782cef442025-04-11WarningsExact identifier
unii: WK2XYI10QM
equaline ibuprofenIBUPROFENUnited Natural Foods, Inc. dba UNFIe18f4ce6-d7d3-4b53-b87a-5900ac3397f12025-04-11WarningsExact identifier
unii: WK2XYI10QM
IBUIBURedPharm Drug, Inc.4db219dc-ea48-490c-e054-00144ff88e882025-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Advil Allergy and Congestion ReliefCHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLCa6cc97d8-252a-4527-a470-6d9e356342fd2025-04-09WarningsExact identifier
unii: WK2XYI10QM
TopCare IbuprofenIBUPROFENTopco Associates LLC66097f19-227c-4f9c-a7f3-ab8476e1bb6e2025-04-08WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENMajor Pharmaceuticals14f43c32-0895-4ef2-aa54-52b952d058fd2025-04-08WarningsExact identifier
unii: WK2XYI10QM
parents choice infants ibuprofenIBUPROFENWal-Mart Stores Inca826d6cc-f582-4508-897d-0d637de0666c2025-04-07WarningsExact identifier
unii: WK2XYI10QM
leader infants ibuprofenIBUPROFENCardinal Health 110, LLC. dba Leaderb72fdf65-8112-4d8b-b86f-8e17a40ee8e62025-04-07WarningsExact identifier
unii: WK2XYI10QM
equaline ibuprofenIBUPROFENUnited Natural Foods, Inc. dba UNFIea2ba726-0199-42ae-9c60-4b068df35e642025-04-07WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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