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 18 of 66 · 1,308 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ibuprofen infantsIBUPROFENHyVee Ince8fcaf17-234a-4d64-b621-9ca505884b0a2026-01-12WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENL.N.K. International, Inc.d3b8d35a-10b5-a31c-8ced-eeb100c0fd7c2026-01-12WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENMeijer Distribution Incc0c64ba5-b6b0-4221-9e44-110d92c937822026-01-12WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCoupler LLC4831785a-cde2-79a2-e063-6294a90a9a402026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENBIONPHARMA INC.4834aa7f-cb0c-ec58-e063-6394a90ae2fc2026-01-12WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENL.N.K. International, Inc.c93da67f-f42e-4baa-976b-73c71ba6dd712026-01-12WarningsExact identifier
unii: WK2XYI10QM
GOOD SENSE CHILDRENS IBUPROFENIBUPROFENL. Perrigo Companycd06ffc5-4921-4b2d-88ea-939fa4daf59c2026-01-09WarningsExact identifier
unii: WK2XYI10QM
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
Xpect IbuprofenIBUPROFENCintas Corporation976ba88a-6428-40d1-a2fd-eac64963ba1d2026-01-08WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENStrides Pharma Inc69b208ff-83f5-40d1-a2ff-d54b390e46e42026-01-08WarningsExact identifier
unii: WK2XYI10QM
Pain Formula Drops 2046PAIN FORMULA DROPSProfessional Complementary Health Formulas4456c022-5aac-49b4-b976-b629525f3d492026-01-08WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENCVS Pharmacyace493e6-91bc-41aa-8e5c-5bc14981de912026-01-06WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen minisIBUPROFENSafeway, Inc.22927a12-6837-4d57-8e60-043000f2f2082026-01-05WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen PMDIPHENHYDRAMINE CITRATE, IBUPROFENSafeway, Inc.e49d1e9e-99a6-4d81-90d6-ef23a584a3d12026-01-05WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENDOLGENCORP, LLC37ccb303-c70e-48b3-a8a3-2b0097cf8f882026-01-05WarningsExact identifier
unii: WK2XYI10QM
DG Health IbuprofenIBUPROFENDolgencorp Inc1dd4ffc5-3132-419b-8e70-78a7bb71da622026-01-02WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENNorthwind Health Company, LLC2f12a20c-4293-d18a-e063-6294a90a3afc2026-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IBUPROFEN PMDIPHENHYDRAMINE CITRATE, IBUPROFENSafeway57e8f0d7-1f21-4fda-8b21-3caa54fae4e62026-01-02WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENNorthwind Health Company, LLCc20f1f4d-59b3-6bbe-e053-2a95a90abaf12026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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