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 47 of 66 · 1,308 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
basic care ibuprofen pmDIPHENHYDRAMINE CITRATE, IBUPROFENAmazon.com Services LLC6bd8bad2-4370-4450-822a-9ef50949a8fc2024-09-09WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAsclemed USA, Inc.ca81671d-1ea8-4c67-802f-adb3a2f087cc2024-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENNuCare Pharmaceuticals, Inc.214e3b3e-87b9-9ff5-e063-6394a90ae96a2024-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENMARKSANS PHARMA LIMITEDe54209c2-f726-440b-ac60-5a72710d2a9b2024-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENTIME CAP LABORATORIES,INC82aad715-f652-471b-840c-5151c66e5ade2024-08-28WarningsExact identifier
unii: WK2XYI10QM
Dual ActionACETAMINOPHEN, IBUPROFENBETTER LIVING BRANDS, LLCf2c096bb-cfed-bfa4-e053-2995a90af2cb2024-08-22WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen MinisIBUPROFENHarris Teeter180557e4-335e-f520-e063-6394a90a2fa42024-08-20WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBryant Ranch Prepackd0198bdc-fe2b-4b09-8f78-9e5a7f6ae7842024-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENWildman Business Group9e71f1c1-5272-4209-8974-6c525b1411552024-08-19WarningsExact identifier
unii: WK2XYI10QM
IBUIBUPROFENNuCare Pharmaceuticals,Inc.593d9870-0213-75e6-e053-2991aa0a0eff2024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IBUIBUPROFENNuCare Pharmaceuticals Inc.575c275c-3e1a-0572-e053-2991aa0adabd2024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENGranules India Limitedfd01353d-1d1d-42b5-9a03-575052189bf52024-08-13WarningsExact identifier
unii: WK2XYI10QM
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R
dual action pain relieverACETAMINOPHEN AND IBUPROFENBionpharma Inc.1f470b1b-81a9-e59c-e063-6394a90a40552024-08-09WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENFlorida Pharmaceutical Products, LLCc1733fdb-5eed-2094-e053-2995a90a6c8e2024-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
dual action pain relieverACETAMINOPHEN AND IBUPROFENBionpharma Inc.1f2f8fcf-bf08-2a21-e063-6394a90a9e712024-08-08WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBryant Ranch Prepack60f1c099-5fb5-47e8-b228-11de1ef40f4b2024-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBryant Ranch Prepackffc953f7-ed92-4528-bb2f-72c634c119fa2024-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAdvanced Rx of Tennessee, LLC19b06eaf-0d4c-2b4d-e063-6294a90a2eb92024-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENP & L Development, LLC6d1c9a64-c83c-4b3d-9245-704b94cb367c2024-07-30WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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