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 58 of 89 · 1,769 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alka-Seltzer Heartburn and PainANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATEBayer HealthCare LLC.2928e140-c868-5bf5-e063-6394a90ab0242024-12-13WarningsExact identifier
unii: XF417D3PSL
IbuprofenIBUPROFENNuCare Pharmaceuticals,Inc.f4d6372a-d560-0e14-e053-2a95a90a435a2024-12-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENSpirit Pharmaceuticals LLCe38d23e5-b455-41b5-86f6-c318b17bd3452024-12-13WarningsExact identifier
unii: WK2XYI10QM
Rite Aid Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATERite Aidb4797380-9cef-d640-e053-2a95a90a06652024-12-11WarningsExact identifier
unii: XF417D3PSL
Top Value Effervescent Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICAROBONATETower Laboratories Ltd44babed8-cf38-1c12-e054-00144ff8d46c2024-12-11Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
Best Choice Effervescent Antacid Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEValu Merchandisers Companyb5e2300a-b77b-53cc-e053-2a95a90a7a6e2024-12-11WarningsExact identifier
unii: XF417D3PSL
VALUMEDS IBUPROFENIBUPROFENSPIRIT PHARMACEUTICALS LLCa6d4ceb0-2b79-496a-aa1e-27edd507ced02024-12-10WarningsExact identifier
unii: WK2XYI10QM
Fendall Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.afda6fc3-7615-b0be-e053-2995a90a62082024-12-10WarningsExact identifier
unii: 059QF0KO0R
Assured IbuprofenIBUPROFENSpirit Pharmaceuticals LLC119263b5-c3b7-46dc-a3bd-9893bfd246282024-12-10WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAAA Pharmaceutical, Inc.39e55ec1-213f-4996-adca-68a5ffbc409b2024-12-06WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENWinco Foods, LLC428b011f-d7d3-4a3b-87dd-d4e84e90cabd2024-12-06WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENWinco Foods, LLC61cd9140-eded-4bcf-894b-a163fa5f3e102024-12-06WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENWinco Foods, LLC60130bdc-6f45-4998-b53a-cad6cbf250362024-12-06WarningsExact identifier
unii: WK2XYI10QM
PROPRINALIBUPROFEN CAPSULES 200 MGHART Healthec27b625-a3fa-4c5f-8134-c9373c09b3e32024-12-04WarningsExact identifier
unii: WK2XYI10QM
Burts Bees Rapid Rescue Cold Sore TreatmentCAMPHOR, GLYCERINBurts Bees9f89735d-205f-4d3e-a1e1-ecc96284fe982024-12-03WarningsExact identifier
unii: PDC6A3C0OX
IbuprofenIBUPROFENSOLA Pharmaceuticals, LLCb19b8c34-e0c1-4982-92fc-34dbe73849352024-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENH E Ba340ed68-debb-4c1e-97eb-82f6e9e3854f2024-12-02WarningsExact identifier
unii: WK2XYI10QM
Advil PM, TRAVEL BASIXIBUPROFEN AND DIPHENHYDRAMINE CITRATELil' Drug Store Products, Inc.b876bb40-a38b-445a-bc8a-466b3bfe166d2024-11-27WarningsExact identifier
unii: WK2XYI10QM
PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3%PURIFIED WATER 98.3%Acme United Corporation9248ee71-2d47-620d-e053-2995a90af5c82024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationcca454e0-b2bd-4215-bc06-426fcc3f7bd62024-11-26WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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