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 46 of 89 · 1,769 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IBUPROFENIBUPROFENAAA Pharmaceutical, Inc.1e686091-6456-36c8-e063-6294a90a38662025-06-17WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAAA Pharmaceutical, Inc.78cf5df8-392b-4a4e-b424-af765a6defdf2025-06-17WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENFSA STORE INC.ec6b015d-e72e-89c4-e053-2a95a90af81c2025-06-17WarningsExact identifier
unii: WK2XYI10QM
Topcare IbuprofenIBUPROFENTopco Associates LLC8be375b0-c729-49de-abc5-2e7d37144b892025-06-16WarningsExact identifier
unii: WK2XYI10QM
good neighbor pharmacy ibuprofenIBUPROFENAmerisource Bergen08d9477e-3033-4b74-8f81-934f39e37e552025-06-16WarningsExact identifier
unii: WK2XYI10QM
equaline ibuprofenIBUPROFENUnited Natural Foods, Inc. dba UNFI9bf3546a-9f94-47b5-9b01-aed93e69d5aa2025-06-16WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENCVS Pharmacye655bd64-dd82-46d8-87cc-2674beaffe202025-06-16WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENMajor Pharmaceuticals03993008-7bd2-465f-b5a9-1cbc3c1fff022025-06-16WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENPublix Super Markets Inc032decc5-9f7a-4f12-8ca4-a95a79a426c62025-06-16WarningsExact identifier
unii: WK2XYI10QM
care one ibuprofen childrensIBUPROFENAmerican Sales Companyc56511fd-ff2e-40f6-91e6-fe04e563fafd2025-06-13WarningsExact identifier
unii: WK2XYI10QM
profen IB childrensIBUPROFENPublix Super Markets Inc1af04e26-e32c-4c1c-bbda-2c78f2030ac62025-06-13WarningsExact identifier
unii: WK2XYI10QM
ADVIL COLD AND SINUSIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEHaleon US Holdings LLCfac22a47-f0de-4505-fd8a-768430cda0c12025-06-13WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENTIME CAP LABORATORIES,INCf58d35f9-e44b-417b-98ce-0766b537cd2f2025-06-12WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENMarc Glassman, Inc.47434f23-5ac9-4cb4-a963-7c8bf9e063612025-06-11WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENMarc Glassman, Inc.3b0e4ccc-cc0b-42fb-9163-7560740d95922025-06-11WarningsExact identifier
unii: WK2XYI10QM
Topcare Childrens IbuprofenIBUPROFENTopco Associates LLC45255d2f-c592-4750-abb5-21647d4fbd512025-06-10WarningsExact identifier
unii: WK2XYI10QM
ibuprofen childrensIBUPROFENMeijer Distribution Inc625226ef-d55b-4f93-ad1e-4fe2b07d41332025-06-10WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENTrifecta Pharmaceuticals USA LLC37299475-e2f3-de26-e063-6394a90ad62d2025-06-09WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENNCS HealthCare of KY, LLC dba Vangard Labsab11e142-9e11-4ce4-9671-7e4fe53ffe922025-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENNCS HealthCare of KY, LLC dba Vangard Labsf1842893-7a34-4f77-8231-55fb0c98b22b2025-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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