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 17 of 66 · 1,308 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENH E B88c7486b-f9a7-4856-a25a-7c06e1382f1a2026-02-02WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENStrategic Sourcing Services, LLCdc469eb2-89cc-46c9-9304-f6cf119c05702026-01-29WarningsExact identifier
unii: WK2XYI10QM
CaldolorIBUPROFENCumberland Pharmaceuticals Inc.1eaa7790-f1a1-4f51-b10a-cbbaf033f6842026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IBUPROFEN 200 MGIBUPROFEN 200 MGFarmacias De Similares TX LLC441f7920-5666-5a3e-e063-6294a90a55832026-01-28WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENSoftgel Healthcare Private Limited2b07ace6-6766-0a06-e063-6294a90ad1bd2026-01-27WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENMajor Pharmaceuticals847758ed-66fc-4db9-8fdb-78f3c3291a032026-01-26WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCVS Pharmacy8d9f11a5-ca98-4280-9c6a-093d32e60ace2026-01-22WarningsExact identifier
unii: WK2XYI10QM
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
equate ibuprofenIBUPROFENWal-Mart Stores Incb29034a6-657b-426f-a41a-5e64c4bc759d2026-01-20WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.70e191ef-8fad-49eb-9850-fceea119e92f2026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.b84ea215-e61d-4c00-8a34-d47c4080779b2026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENWALGREENS40a1e525-fb1e-08f4-e063-6294a90adfa72026-01-14WarningsExact identifier
unii: WK2XYI10QM
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
ibuprofen pmDIPHENHYDRAMINE CITRATE, IBUPROFENHyVee Inc833a2bee-0e55-44f7-b80d-b336ebe52fc92026-01-14WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENL.N.K. International, Inc.82e907e6-86a9-5c7f-93bd-a6319d74100f2026-01-13WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENHYVEE INC45aead8a-37ee-9a66-e063-6394a90a5d172026-01-13WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENHYVEE INC459fc063-0664-09b7-e063-6394a90a89e02026-01-13WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENHYVEE INC459fc670-32a3-61a6-e063-6294a90aea5a2026-01-13WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENL.N.K. International, Inc.8ebe3e16-b7ae-d333-6671-5bc935e259002026-01-13WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENHyVee Inc2fd51545-1d1f-4b2e-a084-d28ba223e7202026-01-13WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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