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 18 of 89 · 1,769 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dolex FlexIBUPROFENPharmadel LLC0543420d-a250-065d-e063-6294a90a005e2026-03-20WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENWestminster Pharmaceuticals, LLC6f7e255f-48c9-4366-8725-7f8cbe1bb75a2026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENNuCare Pharmaceuticals, Inc.2e0f74a5-b8f3-fc81-e063-6394a90a647a2026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
DUAL ACTION BACK PAIN RELIEVERACETAMINOPHEN, IBUPROFENMeijer, Inc.8d9a0c56-ef22-45a6-8b1d-d2b2f32472102026-03-19WarningsExact identifier
unii: WK2XYI10QM
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
IbuprofenIBUPROFENNorthStar Rx LLCaeee629b-255c-40d8-8e95-779aec00f7232026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
AMAZON BASIC CARE IBUPROFEN PMIBUPROFEN AND DIPHENHYDRAMINE CITRATEAmazon.com Services LLC10ec6386-db13-a9dd-e063-6294a90a82612026-03-18WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENGrocery Outlet, Inc.44660e1d-79c2-34ce-e063-6294a90ade3f2026-03-17WarningsExact identifier
unii: WK2XYI10QM
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
CounterAct IBIBUPROFENMelaleuca, Inc7fafc13e-3fee-ace3-e053-2a91aa0ac2ea2026-03-17Boxed warning, WarningsExact identifier
unii: WK2XYI10QM
up and up ibuprofen pmDIPHENHYDRAMINE CITRATE AND IBUPROFENTarget Corporation0c764683-f3c9-4382-96be-d34b7a582aee2026-03-16WarningsExact identifier
unii: WK2XYI10QM
Drop20FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE)Pick Enterprises Corpbaa96813-dc95-472e-a834-880a0cd484a72026-03-13WarningsExact identifier
unii: C151H8M554
Appetrol 20FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE)Carbalor LLCd66234a3-2477-42be-8f7b-283e3a5f87ed2026-03-12WarningsExact identifier
unii: C151H8M554
CHILDRENS IBUPROFENIBUPROFENAdvagen Pharma Ltd.4b8b06f3-8557-4645-af27-c0819e163b792026-03-12WarningsExact identifier
unii: WK2XYI10QM
ADVILIBUPROFENHaleon US Holdings LLC1a665e64-9f30-be37-4a83-38789f1f1e892026-03-12WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENWalgreen Company86818ad6-fd45-4635-9ce8-eac986f008aa2026-03-11WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENDiscount Drug Martd0ebf2a7-551b-4acd-be60-2d0b936dd7032026-03-11WarningsExact identifier
unii: WK2XYI10QM
Optimel Manuka Dry Eye DropsGLYCERINMelcare Biomedical Pty Ltd88c5e2f0-9f7e-62d1-e053-2995a90a90142026-03-11WarningsExact identifier
unii: PDC6A3C0OX
Optimel Manuka Forte Eye GelGLYCERINMelcare Biomedical Pty Ltd8e0ed6e8-51fc-7c5b-e053-2a95a90a35a92026-03-11WarningsExact identifier
unii: PDC6A3C0OX
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLHEB3fb6c1e5-f877-2cd0-e063-6294a90ae6542026-03-11WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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