FDA.reportPublic FDA data

NDC 59368-402 - 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
59368-402
Package NDCs from labels
59368-402-01
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 PRESCRIPTION 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 19 of 91 · 1,805 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Restorative Formula Lubricant Eye DropsPROPYLENE GLYCOLCardinal Health87fef7e4-e5a8-4aad-94d2-f80f34826d972026-03-12WarningsExact identifier
unii: 6DC9Q167V3
CHILDRENS IBUPROFENIBUPROFENAdvagen Pharma Ltd.4b8b06f3-8557-4645-af27-c0819e163b792026-03-12WarningsExact identifier
unii: WK2XYI10QM
ADVILIBUPROFENHaleon US Holdings LLC1a665e64-9f30-be37-4a83-38789f1f1e892026-03-12WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENWalgreen Company86818ad6-fd45-4635-9ce8-eac986f008aa2026-03-11WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENDiscount Drug Martd0ebf2a7-551b-4acd-be60-2d0b936dd7032026-03-11WarningsExact identifier
unii: WK2XYI10QM
Optimel Manuka Dry Eye DropsGLYCERINMelcare Biomedical Pty Ltd88c5e2f0-9f7e-62d1-e053-2995a90a90142026-03-11WarningsExact identifier
unii: PDC6A3C0OX
Optimel Manuka Forte Eye GelGLYCERINMelcare Biomedical Pty Ltd8e0ed6e8-51fc-7c5b-e053-2a95a90a35a92026-03-11WarningsExact identifier
unii: PDC6A3C0OX
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLHEB3fb6c1e5-f877-2cd0-e063-6294a90ae6542026-03-11WarningsExact identifier
unii: WK2XYI10QM
BASIC CARE IBUPROFENIBUPROFENAmazon.com Services LLCae50a548-dc32-4c5b-b133-c6537267127b2026-03-11WarningsExact identifier
unii: WK2XYI10QM
Acetaminophen 250 mg and Ibuprofen 125 mgACETAMINOPHEN 250 MG AND IBUPROFEN 125 MG TABLETSSun Pharmaceutical Industries, Inc.2a31a975-72f9-2a16-e063-6394a90a81492026-03-10WarningsExact identifier
unii: WK2XYI10QM
FleetGLYCERINC.B. Fleet Company, Inc.31778652-e60e-4098-8e90-3e4f56b5800c2026-03-06WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd4c6094b7-c1ef-26a3-e063-6394a90af4cc2026-03-06WarningsExact identifier
unii: PDC6A3C0OX
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
Artificial TearsGLYCERINPreferred Pharmaceuticals Inc.dd646c72-8f47-43c6-a734-db0dcc8cd4d12026-03-06WarningsExact identifier
unii: PDC6A3C0OX
unii: 3NXW29V3WO
IbuprofenIBUPROFENBryant Ranch Prepack0550fa2f-f25e-4abb-b10e-a3d05bdb32172026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBryant Ranch Prepackc38a03fa-6b9a-4737-a848-063ca5c580b92026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUOROFENDirect_Rx90b8b80e-ab30-3590-e053-2a95a90a70ef2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENLegacy Pharmaceutical Packaging, LLC5ca441f9-a4b4-4bd8-aa54-319fae4c3d1a2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENDirect_Rx1aa11b52-1aca-9219-e063-6294a90a470f2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Dry Eye Relief Sterile Lubricant Eye DropsGLYCERINSimilasan Corporation4c4cce1c-392e-354d-e063-6294a90a0ca32026-03-05WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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