FDA.reportPublic FDA data

NDC 59368-003 - up and up dye free infants concentrated 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
59368-003
Package NDCs from labels
59368-003-01, 59368-003-02
Manufacturer
Sixarp, LLC
Effective date
2024-03-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
up and up dye free infants concentrated ibuprofen - Sixarp, LLCSixarp, LLC2024-03-15HUMAN 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 4 of 89 · 1,769 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENREMEDYREPACK INC.560e4e05-21e0-4b2a-ab2f-872b5dbb39012026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
CVS GlycerinGLYCERIN SUPPOISITORYCVS Pharmacy, Incca6d13db-60e8-4fcc-b7b3-3eb280b8c4352026-08-04WarningsExact identifier
unii: PDC6A3C0OX
IbuprofenIBUPROFENChain Drug Marketing Association, Inc.733d0b21-c177-4c60-9243-2f1e7cb5854a2026-08-04WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPioneer Life Sciences, LLC8abd74a4-ad33-4c10-b677-acb469f815e62026-08-03WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPioneer Life Sciences, LLC291602fa-8ebe-4200-bba7-9798c90f8a502026-08-03WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENNUVICARE LLCb063d2dc-d579-46e7-8cfc-1596c803c7f92026-08-03WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENNUVICARE LLC7905edc1-2a45-4adc-a7bc-42b1ddb6ba592026-08-03WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEDoc Rx9f5de6af-e555-4efd-a3ed-b72c34c051b62026-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDERite-Aid483c3bb7-529e-4684-80e1-6646b050988e2026-07-31WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEPublix Super Markets Inc2b98a62b-bd92-4fb8-ad0f-521cb477b6122026-07-31WarningsExact identifier
unii: WK2XYI10QM
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
IbuprofenIBUPROFENAmneal Pharmaceuticals LLC17577b3b-e755-45d1-8b53-775d058578b22026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENAmazon.com Services LLCb5a47efe-222f-4cbd-b649-caafd16a08292026-07-29WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENHarris Teeter637210f0-6494-4656-8b2b-14d7476cb1272026-07-29WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENHarris Teeter9d5c994a-8363-4ddb-956c-e12b79a32a582026-07-29WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENHarris Teeter87ffbf01-54de-45a8-b2a3-367d219278822026-07-29WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENHarris Teeter14515409-736f-4119-b6a0-cb19ee2e948e2026-07-29WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENHarris Teeter1fa28cb4-ae7b-4fa9-ae64-9bd8ccfcc6332026-07-29WarningsExact identifier
unii: WK2XYI10QM
ADVIL PMDIPHENHYDRAMINE HCL, IBUPROFENHaleon US Holdings LLC405afdb4-c157-1d88-f232-848063ba47142026-07-29WarningsExact identifier
unii: WK2XYI10QM
ADVIL COLD AND SINUSIBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEHaleon US Holdings LLC0da9ed22-bfb4-d61b-110b-0c7760332a982026-07-29WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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