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 32 of 66 · 1,308 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dual Back Pain RelieverACETAMINOPHEN, IBUPROFENWalgreen Company9831f374-658a-47ec-8a7e-4ff8359570be2025-07-16WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENDemoulas Super Markets, Inc39802e26-1028-d2fe-e063-6394a90a24c72025-07-16WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAMERIFOODS TRADING COMPANYf6dc62db-f728-66fc-e053-6394a90a96b32025-07-15WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENMARC GLASSMAN, INC.7f366669-9d31-46c7-932d-02fa64b11f302025-07-15WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENMarc Glassman, Inc.9714e804-fadb-103d-e053-2a95a90ad7652025-07-15WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENAMERIFOODS TRADING COMPANYf6dc2a73-046b-6b93-e053-6294a90ab2952025-07-15WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENMARC GLASSMAN, INC.9714de6b-068b-d6b9-e053-2995a90a3b272025-07-15WarningsExact identifier
unii: WK2XYI10QM
Motrin PMIBUPROFEN AND DIPHENHYDRAMINE CITRATEKenvue Brands LLC55403f19-58ae-450b-8a7b-0bc544088f202025-07-11WarningsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENKroger Company91da5b64-db7f-4954-89e8-977b31247f9c2025-07-11WarningsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENRite Aid Corporation70eb40b8-5862-4eb9-adc8-8a9d6bca7c7d2025-07-11WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEPHOENIX RX LLC397f1f23-10c2-569e-e063-6394a90a71642025-07-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Childrens IbuprofenIBUPROFENSafeway0fe94b11-f7c9-4e32-976f-e5f11d01bd642025-07-09WarningsExact identifier
unii: WK2XYI10QM
Foster and Thrive IbuprofenIBUPROFENStrategic Sourcing Services LLCcf330b44-2d69-4f9f-99eb-2caa80aca8732025-07-08WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENSun Pharmaceutical Industries, Inc.6cf3328b-da8f-4f6b-8237-16a4d6b9c8332025-07-07WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENSun Pharmaceutical Industries, Inc.f4dad3d6-1366-4bdf-99eb-370ab74a6b9e2025-07-07WarningsExact identifier
unii: WK2XYI10QM
dg health dual back pain relieverACETAMINOPHEN, IBUPROFENDolgencorp Incb52cfead-1cff-4e11-9953-f470fb785c732025-07-07WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEAurobindo Pharma Limited21688404-41fb-487e-8ba0-aea4431a42fa2025-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENAurohealth LLCb39fb93f-c140-40ab-8247-9559ef6df50a2025-07-03WarningsExact identifier
unii: WK2XYI10QM
IBUIBUPROFENDr. Reddy's Laboratories Limited24731405-219c-79b4-ecf0-7d5fbfda94ba2025-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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