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 20 of 66 · 1,308 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENHumanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd46a9424c-fd7d-f88b-e063-6294a90abceb2025-12-24WarningsExact identifier
unii: WK2XYI10QM
Lil Drug Store IbuprofenIBUPROFENLil Drug Store Products, Inc29190ebf-bb9c-4406-be7b-4427741aeb742025-12-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCVS10424ad8-74fc-4f5f-e063-6394a90a13bd2025-12-23WarningsExact identifier
unii: WK2XYI10QM
good sense ibuprofen childrensIBUPROFENPreferred Pharmaceuticals Inc.7ac61180-d668-4eec-b04f-d14f7b552a4d2025-12-23WarningsExact identifier
unii: WK2XYI10QM
Hydrocodone Bitartrate and IbuprofenHYDROCODONE BITARTRATE AND IBUPROFENAurolife Pharma, LLC470df63a-5c0f-42df-9023-a330a901153e2025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Motrin IB MigraineIBUPROFENKenvue Brands LLC34818110-5291-4bda-9571-bd77d90bba7c2025-12-22WarningsExact identifier
unii: WK2XYI10QM
Motrin IBIBUPROFENKenvue Brands LLCd9fc716a-fba5-45f8-8024-52325799d1dd2025-12-22WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENGranules USA, Inc.8cb595d2-b7c2-687d-e053-2a95a90a57202025-12-22WarningsExact identifier
unii: WK2XYI10QM
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENWAL-MART STORES INC.0aaddde9-4317-a828-e063-6294a90a26d52025-12-19WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENRetail Business Services, LLC04115ec1-ef31-1746-e063-6394a90a0a522025-12-19WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENRETAIL BUSINESS SERVICES,LLC.a567dc6f-bd83-b9f5-e053-2995a90a05ee2025-12-19WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENRETAIL BUSINESS SERVICES,LLC.a568fd1e-9bf0-3c03-e053-2a95a90a45b72025-12-19WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENTOPCO ASSOCIATES LLC1a00c17f-9766-deaa-e063-6394a90a8d602025-12-19WarningsExact identifier
unii: WK2XYI10QM
Acetaminophen and Ibuprofen (NSAID)ACETAMINOPHEN AND IBUPROFEN (NSAID)RETAIL BUSINESS SERVICES,LLCe7b7009a-89a4-720d-e053-2a95a90abff72025-12-19WarningsExact identifier
unii: WK2XYI10QM
AcetaminophenACETAMINOPHENRAONBIO CORPf6f5251d-db89-4b69-e053-6394a90a10282025-12-19WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENTOPCO ASSOCIATES LLC1a00c85b-2ba5-32c3-e063-6294a90af1482025-12-19WarningsExact identifier
unii: WK2XYI10QM
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENLEADER/ Cardinal Health 110, Inc.f1d69088-4d52-cbb5-e053-2995a90a3ec82025-12-19WarningsExact identifier
unii: WK2XYI10QM
Childrens Ibuprofen Oral SuspensionIBUPROFENMarc Glassman, Inc.0ef3f4b3-9af5-4243-8d45-dd68f72852292025-12-19WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENWALGREENS CO.b8a77b7e-e161-b3ac-e053-2995a90af3e82025-12-19WarningsExact identifier
unii: WK2XYI10QM
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENRUGBY LABORATORIESed340993-04e6-b084-e053-2a95a90abf602025-12-19WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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