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 59 of 66 · 1,308 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLCVS Pharmacyce4378c0-848e-7878-e053-2a95a90af0f32022-12-27WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENKROGER COMPANY3b95dcbf-aef1-44b5-a2c4-5ce93c57ff1d2022-12-27WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC.aa91952b-512f-0ead-e053-2995a90a94552022-12-21WarningsExact identifier
unii: WK2XYI10QM
Pediacare Childrens Ibuprofen BerryIBUPROFENRANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH347d081f-068c-4173-9b4b-001ab2b891f52022-12-20WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBionpharma Inc.ba89fbe6-546a-e10c-e053-2a95a90ade0c2022-12-20WarningsExact identifier
unii: WK2XYI10QM
pain relief pmIBUPROFEN, DIPHENHYDRAMINE HCLBionpharma Inc.58666a5c-fc92-4c8d-9c04-f0c98dc05c562022-12-20WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENINGLES MARKETS, INC.ef536841-768c-919f-e053-2a95a90af5992022-12-12WarningsExact identifier
unii: WK2XYI10QM
Diphenhydramine HCl and IbuprofenDIPHENHYDRAMINE HCL AND IBUPROFENAurohealth LLC39af6dfa-e822-43a5-bd1a-338cf5da89ce2022-12-09WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENWalgreens6bd8a0c2-314f-47cb-80cd-1d4dd92b209f2022-11-29WarningsExact identifier
unii: WK2XYI10QM
Concentrated ibuprofen infantsIBUPROFENGuardian Drug Company3a32f0c7-c03e-4783-a429-08280993ddfb2022-11-28WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENTOPCO ASSOCIATES LLCcef74c2f-0c23-609d-e053-2a95a90a6b8e2022-11-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCare One (American Sales Company)016299ef-ad40-46fd-acfc-e74ffee3d9b42022-11-21WarningsExact identifier
unii: WK2XYI10QM
signature care childrens ibuprofenIBUPROFENSafewayc30fbb8f-a293-4f6e-9495-11402548fe2d2022-11-15WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENDolgencorp, Inc. (DOLLAR GENERAL & REXALL)7f510feb-023c-4974-af6d-3e7a30cef3622022-11-07WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENDolgencorp, Inc. (DOLLAR GENERAL & REXALL)8de40427-1be3-4a86-bc4c-9659ebaa203f2022-11-07WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen and Pseudoephedrine HClIBUPROFEN AND PSEUDOEPHEDRINE HCLAmerisource Bergen8d397f4f-ac5e-426d-a26b-ee064b6e50282022-11-04WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENProficient Rx LP9e9fb921-6b6a-422e-95b6-41d6b9047b802022-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
DG Health childrens ibuprofenIBUPROFENDolgencorp, LLC0fd6fcca-cbfe-48af-80dd-2607b5d51b532022-10-13WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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