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 16 of 66 · 1,308 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
childrens ibuprofenIBUPROFENCVS Pharmacy215e2275-2968-419c-9a89-8dbb3b4f4d2e2026-02-27WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENCVS Pharmacye28d0916-8165-431c-a19c-ef7d4bb6b8e62026-02-26WarningsExact identifier
unii: WK2XYI10QM
Leader IbuprofenIBUPROFENCardinal Health 110, LLC. dba Leaderd673266c-3d2b-479f-9b53-cdd1b86513932026-02-25WarningsExact identifier
unii: WK2XYI10QM
equate ibuprofen childrensIBUPROFENWal-Mart Stores Inc7817923f-4c21-4943-a7e2-dad4e2915fc42026-02-23WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENHyVee Incc20a9bc5-e481-4fb2-ad10-d01e83e43ca02026-02-21WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC4522b794-5c93-44cd-e063-6394a90ab39a2026-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENNuCare Pharmaceuticals, Inc.4b34b58b-2cf7-9aa8-e063-6294a90a06582026-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
CVS IbuprofenIBUPROFENCVS Pharmacy3d71e29f-0648-7377-e063-6294a90a8a292026-02-17WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENA-S Medication Solutions0170876a-d8cd-4a2d-8397-db2acdf72ffb2026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Ibuprofen ChildrensIBUPROFENMajor Pharmaceuticals9d56e64d-7860-4fd1-88d2-c537e50079d82026-02-13WarningsExact identifier
unii: WK2XYI10QM
childrens ibuprofenIBUPROFENHyVee Incd522a3ac-dd43-4faa-b3f8-69313be1c8292026-02-11WarningsExact identifier
unii: WK2XYI10QM
good sense dual actionACETAMINOPHEN, IBUPROFENSportpharm LLC3f4ade2c-56e0-4aab-910e-73c26546a4d72026-02-06WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENMajor Pharmaceuticals42b6faf5-ef47-6a7a-e063-6394a90ac4092026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENHyVee Inc4c24c884-55f7-40b4-8d6f-db6144d5ebcb2026-02-05WarningsExact identifier
unii: WK2XYI10QM
CareOne IbuprofenIBUPROFENAmerican Sales Company03cdff8a-8890-440d-82b5-54ce809f88cc2026-02-03WarningsExact identifier
unii: WK2XYI10QM
Pain Relief IbuprofenIBUPROFENRite Aid Corporationc85c3d1f-7639-4cfa-bf3a-424b61757b1a2026-02-03WarningsExact identifier
unii: WK2XYI10QM
Motrin Dual Action With TylenolACETAMINOPHEN AND IBUPROFENKenvue Brands LLCf2ee9cf5-02b7-6612-e053-2995a90a90c42026-02-03WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENHyVee Inc5233c409-3743-4312-9f75-14ded6755b5c2026-02-02WarningsExact identifier
unii: WK2XYI10QM
pain relief ibuprofenIBUPROFENRite Aid Corporation2bd1438e-27b1-81ff-f8e1-0f5b50b045812026-02-02WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENL.N.K. International, Inc.8b5eec38-bdf3-4f27-802f-f4c732ae5c7d2026-02-02WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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