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 35 of 89 · 1,769 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Up and Up Childrens IbuprofenIBUPROFENTarget Corporation17b3ca97-1bd6-4e76-a47f-2e35ef36b7072025-10-28WarningsExact identifier
unii: WK2XYI10QM
childrens ibuprofen 100IBUPROFENWalgreen Company7b798146-393f-422c-87f0-0bf800df0c712025-10-28WarningsExact identifier
unii: WK2XYI10QM
careone childrens ibuprofenIBUPROFENAmerican Sales Companybca90b40-7973-4f22-8647-44cce5a6036e2025-10-28WarningsExact identifier
unii: WK2XYI10QM
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
IbuprofenIBUPROFENA-S Medication Solutions8d5f7d2a-af48-4d47-8bf5-48f01c092d242025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
LACRIFRESH HYDRAPFGLYCERIN, POVIDONEAVIZOR, S.A.41bbd23e-0ec8-eb18-e063-6294a90a46d12025-10-27WarningsExact identifier
unii: PDC6A3C0OX
LACRIFRESH HYDRAMAXPFGLYCERIN, POVIDONEAVIZOR, S.A.41be1604-89b4-7ec3-e063-6294a90a33312025-10-27WarningsExact identifier
unii: PDC6A3C0OX
IbuprofenIBUPROFENA-S Medication Solutions4b75bd6f-5455-4237-991c-eacc0fdcf7092025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
childrens ibuprofen 100IBUPROFENWalgreen Company9b748f51-1d09-46ca-9dba-fec226c027e02025-10-26WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCVS Pharmacy93f8101c-1cf7-4cb0-9c00-c57c9f9023c82025-10-26WarningsExact identifier
unii: WK2XYI10QM
Up and Up Childrens IbuprofenIBUPROFENTarget Corporationeead7d57-dfd3-4007-a620-74afebc3d3652025-10-26WarningsExact identifier
unii: WK2XYI10QM
GlycerinGLYCERINDSC Laboratories Inc.5e97aa5b-62e2-0664-e053-2a91aa0ac3412025-10-24WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINH E B3d03ce42-e671-6d76-e054-00144ff8d46c2025-10-24WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINChain Drug Consortium LLC022dd494-cb3c-4fa7-be99-4c38fabdc6122025-10-24WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINDSC Laboratories Inc.5e97c4d2-e41d-5bb6-e053-2a91aa0a31632025-10-24WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINCVS Pharmacy94e4a6f3-43d0-b2a5-e053-2a95a90aa1152025-10-24WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINChain Drug Marketing Association Inc.5e83d3ef-91c5-1c3a-e053-2a91aa0a93ed2025-10-24WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINRite Aid Corporation5da2ea79-f3bc-b82b-e053-2a91aa0af0af2025-10-24WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINRite Aid Corporation5da2ea79-f37a-b82b-e053-2a91aa0af0af2025-10-24WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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