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 70 of 89 · 1,769 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
signature care ibuprofenIBUPROFENSafeway95904b21-752d-48b4-a882-8d81d2384e1f2024-02-01WarningsExact identifier
unii: WK2XYI10QM
Sterile WaterWATERA-S Medication Solutionsdba87371-31d2-47c2-ab83-89aabce4b1842024-01-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Childrens FLANAX ORALIBUPROFENBelmora LLC9b9318cb-3bc7-40ca-bf8a-7495d93869b32024-01-30WarningsExact identifier
unii: WK2XYI10QM
good sense ibuprofenIBUPROFENA-S Medication Solutions57af05fc-30b9-4487-9a37-fb35dac4acf72024-01-29WarningsExact identifier
unii: WK2XYI10QM
PROPRINALIBUPROFEN CAPSULES 200 MGA-S Medication Solutions4723dd14-5d20-4a9a-b127-4237d5db59562024-01-29WarningsExact identifier
unii: WK2XYI10QM
No More ProductsGLYCERIN, KAOLIN, CALAMINE, MENTHOLSarati International, Inc102e7dbb-06dc-f4d1-e063-6394a90aa3eb2024-01-26WarningsExact identifier
unii: PDC6A3C0OX
Pranicura 5GLYCERIN, KAOLIN, CALAMINE, MENTHOLSarati International, Inc.0fe10710-ac59-4fc5-e063-6294a90a48fc2024-01-26WarningsExact identifier
unii: PDC6A3C0OX
IbuprofenIBUPROFENA-S Medication Solutionsfd691a4a-8010-45e6-b3da-b26374792f242024-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENHART Health1c1374e1-890f-48ab-8f93-e84da9d5bf842024-01-25WarningsExact identifier
unii: WK2XYI10QM
dg health Ibuprofen pmDIPHENHYDRAMINE CITRATE AND IBUPROFENDolgencorp Inc4bbe40de-0957-4705-893d-fcb4191885c92024-01-22WarningsExact identifier
unii: WK2XYI10QM
GENTEAL TEARSDEXTRAN 70, GLYCERIN, HYPROMELLOSEA-S Medication Solutionsa2b715e9-332d-4f0b-b8e5-ebc0006815862024-01-21WarningsExact identifier
unii: PDC6A3C0OX
unii: 3NXW29V3WO
Hydro GelGLYCERIN 20%Trifecta Pharmaceuticals USA LLC02e8e5d0-7844-39fe-e063-6394a90a57e12024-01-19WarningsExact identifier
unii: PDC6A3C0OX
Ibuprofen OralIBUPROFEN ORALBryant Ranch Prepack6dc47070-4185-404f-94b0-5252a78ea6fe2024-01-18WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen OralIBUPROFEN ORALBryant Ranch Prepacke4e778f3-97f9-4fd7-8eb8-9ceb5bc9ee7d2024-01-18WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen OralIBUPROFEN ORALBryant Ranch Prepack3762ee9b-5811-46e2-83df-db5f6863e0552024-01-18WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBryant Ranch Prepacke90c573d-eb0f-45a5-94d1-efdd3d2b7a112024-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
A01 CELLULAR RECHARGEACETICUM ACIDUM, ARNICA MONTANA, AVENA SATIVA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CEANOTHUS AMERICANUS, CERATOSTIGMA ILLMOTTIANUM, CHININUM ARSENICOSUM, CITRICUM ACIDUM, ENGLISH ELM, EUROPEAN HORNBEAM, EUROPEAN OLIVE, GENTIANELLA AMARELLA, HYDROFLUORICUM ACIDUM, JUGLANS REGIA, LACTICUM ACIDUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SILICOFLUORICUM, NATRUM SULPHURICUM, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, SARCOLACTICUM ACIDUM, SOLIDAGO VIRGAUREAApex Energetics Inc.b932ebd3-afea-6a95-e053-2995a90a27352024-01-08WarningsExact identifier
unii: XF417D3PSL
A12 DTX-KIDNEYAPIS MELLIFICA, BERBERIS VULGARIS, BETULA PUBESCENS BARK, BETULA VERRUCOSA LEAF, BOS TAURUS KIDNEY, BOS TAURUS URINARY BLADDER, CITRICUM ACIDUM, CITRUS LIMONUM, FAGUS SYLVESTRIS FLOWER BUD, NATRUM MURIATICUM, PETROSELINUM SATIVUM, QUERCUS ROBUR FLOWER BUD, SINUSITISINUM, SOLIDAGO VIRGAUREAApex Energetics Inc.bf52e26f-aa27-87ca-e053-2995a90a23e72024-01-08WarningsExact identifier
unii: XF417D3PSL
A04 DEEP ANTITOXALLIUM CEPA, ALLIUM SATIVUM, ALOE SOCOTRINA, ARSENICUM IODATUM, ASTERIAS RUBENS, BAPTISIA TINCTORIA, CALCAREA IODATA, CANDIDA ALBICANS, CARBO VEGETABILIS, CHELIDONIUM MAJUS, CINA, CINCHONA OFFICINALIS, COLCHICUM AUTUMNALE, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, INDOLUM, LAC VACCINUM, LACTICUM ACIDUM, MILLEFOLIUM, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, SCROPHULARIA NODOSA, SKATOLUM, SOLIDAGO VIRGAUREA, SULPHUR, URICUM ACIDUMApex Energetics Inc.b9bbbddf-b822-4780-e053-2a95a90afbba2024-01-08WarningsExact identifier
unii: C151H8M554
B05 GLUCO BALANCEADRENALINUM, ARGENTUM NITRICUM, BOS TAURUS PITUITARUM POSTERIUM, GLYCERINUM, GLYCYRRHIZA GLABRA, KALI CARBONICUM, LACTICUM ACIDUM, MAGNESIA SULPHURICA, NICCOLUM METALLICUM, PANCREATINUM, PHOSPHORICUM ACIDUM, SACCHARINUM, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SYZYGIUM JAMBOLANUM, THYROIDINUM, ZINCUM METALLICUMApex Energetics Inc.bae9ff7e-eb69-c61d-e053-2995a90a26272024-01-08WarningsExact identifier
unii: C151H8M554
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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