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 53 of 89 · 1,769 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
equate ibuprofenIBUPROFENWal-Mart Stores Inc2daee8c1-d05e-406b-af65-b81bbbaa244d2025-03-03WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENPadagis Israel Pharmaceuticals Ltd02889717-204c-463b-8506-4c5cf18c77d32025-03-03WarningsExact identifier
unii: WK2XYI10QM
Clear Eyes Maximum Redness ReliefNAPHAZOLINE HYDROCHLORIDE AND GLYCERINPrestige Brands Holdings, Inc.c3b0e344-68dd-4c35-bf46-744e612a5b152025-02-28WarningsExact identifier
unii: PDC6A3C0OX
Ibuprofen and Pseudoephedrine hydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEOhm Laboratories Inc.65ec0f85-7ca3-4adc-b152-a0ae2fd0692f2025-02-27WarningsExact identifier
unii: WK2XYI10QM
AlcostatTARAXACUM OFFICINALE, AVENA SATIVA, PASSIFLORA INCARNATA, AURUM METALLICUM, CAPSICUM ANNUUM, CHELIDONIUM MAJUS, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NOX VOMICA, QUERCUS GLANDIUM SPIRITUS, SULPHURICUM ACIDUM, ETHYLICUM, CARCINOSIN, SACCHARUM OFFICINALEEnergique, Inc.77daea02-3c32-4ba3-a7a8-af79b13ddc062025-02-27WarningsExact identifier
unii: C151H8M554
AeroTab IbuprofenIBUPROFEN TABLETAero Healthcareddd0f7fb-ae4b-c584-e053-2a95a90a09842025-02-26WarningsExact identifier
unii: WK2XYI10QM
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
Blink Nourish Dry EyeGLYCERINBausch & Lomb Incorporatedcf2b4e19-af0a-472e-9a2d-9b4fa3e9c9a42025-02-25WarningsExact identifier
unii: PDC6A3C0OX
Childrens IbuprofenIBUPROFENDiscount Drug Mart, Inc2d58d1c4-b864-6bb8-e063-6394a90a71172025-02-24WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen OralIBUPROFEN ORALStrategic Sourcing Services863f7ce3-b7b9-4c66-b351-5b95dd23dcb42025-02-20WarningsExact identifier
unii: WK2XYI10QM
Bestmade Natural Products BM164ACID PHOS, ARUM TRYPH, BALSAMUM PERU, CAUSTICUM, EQUISETUM, GLYCERINUM, HELONIAS DIOBestmade Natural Products2e6e49aa-278e-5499-e063-6394a90a999c2025-02-18WarningsExact identifier
unii: PDC6A3C0OX
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R
SODIUM PHENYLACETATE and SODIUM BENZOATESODIUM PHENYLACETATE AND SODIUM BENZOATEOmnivium Pharmaceuticals LLC9067c301-74f9-457a-9b0f-b7e9b06a35082025-02-15Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
Hydropure Lubricating Eye DropsGLYCERINOTE North America17f5b6e5-dc14-45c7-e063-6294a90af43d2025-02-14WarningsExact identifier
unii: PDC6A3C0OX
IbuprofenIBUPROFENAurobindo Pharma Limited00872852-680a-41b3-901b-b991b12a176d2025-02-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Dye Free Childrens IbuprofenIBUPROFENPrecision Dose Inc.eccee4c6-aa94-468a-aebd-265d7a9efb6d2025-02-12WarningsExact identifier
unii: WK2XYI10QM
Equate IbuprofenIBUPROFENWal-Mart Stores Inc01e9b5b9-cb49-4bfa-9a90-ece8940bf7682025-02-11WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBrisk Pharmaceuticals2dcbe4bb-fb24-e827-e063-6394a90acf9f2025-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R
Tyson 2.0 Mike Red Eye Drops For Dry High EyesGLYCERIN, NAPHAZOLINE HCLJbrands Pharma L.L.C.288e9c85-0562-89bf-e063-6394a90a110d2025-02-07WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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