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 54 of 66 · 1,308 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dual Action Pain ReliefACETAMINOPHEN, IBUPROFENTIME CAP LABORATORIES, INC.08acd3bf-ad0c-f693-e063-6394a90ad8c22023-10-27WarningsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENChain Drug Marketing Association Inc.ba0baba6-a7f9-4e4c-88f7-c7fbecc61f252023-10-25WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen minisIBUPROFENDolgencorp, Inc. (DOLLAR GENERAL & REXALL)2b9e71c5-9b32-4b1b-a479-e5457a1f9afd2023-10-16WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENMeijer Distribution Ince578de96-747e-4104-8db6-e6521e6052a52023-10-09WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAsclemed USA, Inc.793e4b36-8208-4fa3-9f4f-9e9e726482802023-10-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBryant Ranch Prepack8fafa916-733a-4c7d-99da-6ca2ed54e1e42023-10-06WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENVALU MERCHANDISERS COMPANYfed2f7ae-2825-f967-e053-6294a90adc0a2023-10-05WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENStrategic Sourcing Services LLC9f020645-ba77-49e1-b9f1-0e36cdf26adb2023-10-05WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen and Diphenhydramine HClIBUPROFEN, DIPHENHYDRAMINE HCLVALU MERCHANDISERS COMPANYfed2f7ae-2827-f967-e053-6294a90adc0a2023-10-03WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBETTER LIVING BRANDS, LLCeb613c44-e125-0f40-e053-2995a90a7ca52023-10-02WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBETTER LIVING BRANDS, LLCeb60e636-41fe-49fb-e053-2a95a90a06162023-09-29WarningsExact identifier
unii: WK2XYI10QM
Signature Care IbuprofenIBUPROFENSafeway93edca03-fdf1-453f-8efe-5f0b8eef41e42023-09-28WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBetter Living Brands LLCf6ef7f73-b5ab-4c82-e053-6394a90ac81e2023-09-22WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFEN CAPSULES 200 MGTIME CAP LABORATORIES, INC.c7c51cf3-9e95-f8d0-e053-2995a90a73712023-09-18WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen MinisIBUPROFENAurohealth LLCd0b03d99-477f-4250-ac84-576b1baf2eed2023-09-15WarningsExact identifier
unii: WK2XYI10QM
Dolex FlexIBUPROFENPharmadel LLC822d9def-504c-9beb-e053-2991aa0a280e2023-09-13WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENA-S Medication Solutionse4644cb5-7fae-456a-98d3-62ba521cd0b22023-09-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Ibuprofen and Pseudoephedrine HClIBUPROFEN AND PSEUDOEPHEDRINE HCLWALGREEN CO.1cc6e3f0-64f7-4974-a62c-5db46ca9e7c52023-09-08WarningsExact identifier
unii: WK2XYI10QM
ANUBISMEDHA HYALURONICANUBIS COSMETICS SLeac771e2-4c1b-3808-e053-2995a90ac5fc2023-09-05WarningsExact identifier
unii: 059QF0KO0R
AnubisMedSPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSIONANUBIS COSMETICS SLe99d92c4-8768-9c0a-e053-2a95a90a609e2023-09-05WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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