FDA.reportPublic FDA data

NDC 59368-395 - 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
59368-395
Package NDCs from labels
59368-395-02, 59368-395-01
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 31 of 66 · 1,302 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENPHOENIX RX LLC3b17587e-b609-42a9-e063-6294a90ab1f82025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Childrens Ibuprofen Oral SuspensionIBUPROFENPAI Holdings, LLC dba PAI Pharmac26cefe0-182a-4b03-baeb-b3eb2e0e22672025-08-01WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEPreferred Pharmaceuticals Inc.e2f29ca9-9ec8-4b82-8c80-8628d9e3ab2f2025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Acetaminophen, IbuprofenACETAMINOPHEN, IBUPROFENGLENMARK THERAPEUTICS INC., USA57a8dc2b-a3bc-49fa-b605-2330155bdbff2025-07-31WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENDolgencorp, Inc. (DOLLAR GENERAL & REXALL)0e95aab9-3a7c-49c3-b8df-f66d6f31aee02025-07-31WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENRite Aid Corporation47657d95-4a54-49c2-8273-86b413b8f41e2025-07-30WarningsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENPublix Super Markets Inc54ae0273-4d8d-4c3b-85ff-675ba96f00de2025-07-22WarningsExact identifier
unii: WK2XYI10QM
ADVIL SINUS CONGESTION AND PAINIBUPROFEN, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLCb1e29c19-fe03-4d2b-b966-0adf4eb4b4cf2025-07-22WarningsExact identifier
unii: WK2XYI10QM
INFANTS IBUPROFENIBUPROFENSafeway6fed7c65-69a3-4899-a85d-23ea95f571a42025-07-21WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENSOLA Pharmaceuticals, LLC44fb0842-c34e-477e-96df-350cd5d6800e2025-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENChain Drug Consortium6c593a9c-680e-4645-8e8f-d8d044c92ca12025-07-18WarningsExact identifier
unii: WK2XYI10QM
Dual ActionACETAMINOPHEN AND IBUPROFEN (NSAID) TABLETS, 250 MG/ 125 MGDr. Reddy's Laboratories Incc8a8a18a-6766-37a9-d0f0-f9380fb5b0e82025-07-18WarningsExact identifier
unii: WK2XYI10QM
topcare childrens ibuprofenIBUPROFENTopco Associates LLCa88020c0-7982-4307-9836-74de66ea47a52025-07-17WarningsExact identifier
unii: WK2XYI10QM
profen ib infantsIBUPROFENPublix Super Markets Inc84aea3fc-4f3b-4a76-a3a6-94ed6549dbea2025-07-17WarningsExact identifier
unii: WK2XYI10QM
childrens ibuprofenIBUPROFENMeijer Distribution Inccfe27d2a-b602-4b3e-bdcb-14fed4a236ca2025-07-17WarningsExact identifier
unii: WK2XYI10QM
Dg Health IbuprofenIBUPROFENDolgencorp, LLC9022e393-084e-499b-ac84-f35360d795922025-07-17WarningsExact identifier
unii: WK2XYI10QM
Dual Back Pain RelieverACETAMINOPHEN, IBUPROFENWalgreen Company9831f374-658a-47ec-8a7e-4ff8359570be2025-07-16WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENDemoulas Super Markets, Inc39802e26-1028-d2fe-e063-6394a90a24c72025-07-16WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAMERIFOODS TRADING COMPANYf6dc62db-f728-66fc-e053-6394a90a96b32025-07-15WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENMARC GLASSMAN, INC.7f366669-9d31-46c7-932d-02fa64b11f302025-07-15WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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