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 30 of 66 · 1,308 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Neighbor Pharmacy Childrens IbuprofenIBUPROFENAmerisource Bergenf0a7070b-8acf-49f0-88c8-c841f73242d82025-08-28WarningsExact identifier
unii: WK2XYI10QM
foster and thrive ibuprofenIBUPROFENStrategic Sourcing Services LLCcfa8578c-2bcc-4aa7-bb8c-0d0e193020ed2025-08-28WarningsExact identifier
unii: WK2XYI10QM
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
good neighbor pharmacy childrens ibuprofenIBUPROFENAmerisource Bergen7a314b7f-91d6-4196-bd96-2470ff7b0b252025-08-28WarningsExact identifier
unii: WK2XYI10QM
CAREONE DUAL ACTIONACETAMINOPHEN, IBUPROFENRetail Business Services, LLC76302cb3-0371-49ce-85d8-5f3785c370b02025-08-25WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENRite Aid Corporation389454b7-c17d-4413-b1ab-dee9a13f81cf2025-08-25WarningsExact identifier
unii: WK2XYI10QM
childrens ibuprofenIBUPROFENKroger Company1b78bdeb-efb2-4f5a-af3f-d67d820908472025-08-22WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENPublix Super Markets Incc5cd3843-8d72-4850-bebe-4ac54e4f43fa2025-08-21WarningsExact identifier
unii: WK2XYI10QM
equate ibuprofenIBUPROFENWal-Mart Stores Incabef43bc-ee9b-4a9c-9cf9-36c3232139092025-08-21WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENBryant Ranch Prepack230fd746-92e0-40b6-9a90-595812bd8a182025-08-20WarningsExact identifier
unii: WK2XYI10QM
childrens ibuprofenIBUPROFENMeijer Distribution Incd42f9f7c-fe4f-45eb-a455-bffb41295fdc2025-08-20WarningsExact identifier
unii: WK2XYI10QM
equaline childrens ibuprofenIBUPROFENUnited Natural Foods, Inc. dba UNFI3a166a74-cdc4-4620-b796-750464e15dc02025-08-20WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBJWC (Berkley & Jensen / BJ's)2f322afb-bfc8-9dab-e063-6394a90a08b52025-08-19WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENRite Aid Corporation9372c47d-2a3c-4f44-86f8-7568657844e72025-08-19WarningsExact identifier
unii: WK2XYI10QM
Leader IbuprofenIBUPROFENCardinal Health 110, LLC. dba Leader63b8d389-7feb-41d2-8970-b7d5660ccb4a2025-08-14WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENFSA STORE INC.ec6b1b86-46fc-7e82-e053-2a95a90ac1472025-08-12WarningsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENPrecision Dose Inc.fbbc67a7-359f-4155-9367-3815c05ccf032025-08-08WarningsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENPrecision Dose Inc.59b881f9-1830-4bce-99d2-9770c9b2575f2025-08-08WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPROSTAT FIRST AID3bca27b4-3df6-b7d1-e063-6394a90ac6af2025-08-07WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAdvanced Rx of Tennessee, LLCaf9ac948-440c-5abf-e053-2995a90af2b52025-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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