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 42 of 89 · 1,769 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENFSA STORE INC.ec6b1b86-46fc-7e82-e053-2a95a90ac1472025-08-12WarningsExact identifier
unii: WK2XYI10QM
Norms HemorrhoidGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLTotally Normal Company3bdf8c74-3db6-1805-e063-6394a90aaba02025-08-08WarningsExact identifier
unii: PDC6A3C0OX
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
Durma DynaGelDURMA DYNAGELDynarex Corporation3bcbe314-98ca-78f1-e063-6394a90a13ad2025-08-07WarningsExact identifier
unii: PDC6A3C0OX
IbuprofenIBUPROFENAdvanced Rx of Tennessee, LLCaf9ac948-440c-5abf-e053-2995a90af2b52025-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Medics Choice Fresh and SootheCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINUnimed3bcd8394-f486-d306-e063-6294a90a4e9a2025-08-07WarningsExact identifier
unii: PDC6A3C0OX
IbuprofenIBUPROFENEQUATE (WAL-MART STORES, INC.)104b5ac1-9c5e-40f8-a9b1-1761b495bb1c2025-08-06WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAdvanced Rx of Tennessee, LLC3b9fdc48-c071-4e2c-e063-6294a90a679f2025-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
CHILDRENS IBUPROFENIBUPROFENMeijer, Inc.eed4f13d-4bee-4ccc-a651-a6f86d6d1f7b2025-08-04WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAsclemed USA, Inc.d7ed42c4-371c-4a54-ab15-0630656f04272025-08-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPHOENIX RX LLC3b17587e-b609-42a9-e063-6294a90ab1f82025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Medics Choice Fresh and SootheCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINKC Pharmaceuticals, Inc.3bc03d54-6b31-5921-e063-6294a90af5992025-08-01WarningsExact identifier
unii: PDC6A3C0OX
Childrens Ibuprofen Oral SuspensionIBUPROFENPAI Holdings, LLC dba PAI Pharmac26cefe0-182a-4b03-baeb-b3eb2e0e22672025-08-01WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEPreferred Pharmaceuticals Inc.e2f29ca9-9ec8-4b82-8c80-8628d9e3ab2f2025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Acetaminophen, IbuprofenACETAMINOPHEN, IBUPROFENGLENMARK THERAPEUTICS INC., USA57a8dc2b-a3bc-49fa-b605-2330155bdbff2025-07-31WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENDolgencorp, Inc. (DOLLAR GENERAL & REXALL)0e95aab9-3a7c-49c3-b8df-f66d6f31aee02025-07-31WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENRite Aid Corporation47657d95-4a54-49c2-8273-86b413b8f41e2025-07-30WarningsExact identifier
unii: WK2XYI10QM
Doctor Butler Hemorrhoid and Fissure Advanced FormulaGLYCERIN 37.5%, LANOLIN 12.5%, LIDOCAINE 4%, ZINC OXIDE 5%Beyond Health, PAd2a769e2-afd0-aed2-e053-2995a90ad4292025-07-23WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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