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 85 of 89 · 1,769 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Migraine ReliefIBUPROFENBionpharma Inc.662ae0e0-bd44-4db4-8083-fc2e11d49abe2021-08-24WarningsExact identifier
unii: WK2XYI10QM
basic care childrens ibuprofenIBUPROFENAmazon.com Services LLCb17b0aac-55d2-4917-a722-b8587ad643bc2021-08-13WarningsExact identifier
unii: WK2XYI10QM
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
dg health childrens ibuprofenIBUPROFENDolgencorp, LLCad8475b3-ace1-4a05-b927-3286a8139cb42021-05-26WarningsExact identifier
unii: WK2XYI10QM
IBUIBUPROFENAphena Pharma Solutions - Tennessee, LLCb0f03994-b744-4d66-95b7-8c86217882bc2021-05-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
basic care infants ibuprofenIBUPROFENAmazon.com Services LLC581dca08-a4a4-476a-a7cf-fa0f8630c7772021-05-04WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENAphena Pharma Solutions - Tennessee, LLC77adb094-869c-44b4-8a4e-b739ac9cd7012021-04-20Exact identifier
unii: WK2XYI10QM
IBUIBUPROFENAphena Pharma Solutions - Tennessee, LLC3e45f971-b6f7-4ec5-9d8e-1b9127b6c0bd2021-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ibuprofenIBUPROFENProficient Rx LP924d2dd0-3b7d-42ec-b617-86729dba2b952021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENProficient Rx LPe23eb275-ce0c-40ec-b809-a48c5e46c7ec2021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Food AdditivesIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,Newton Laboratories, Inc.9a61f1ae-d3a4-68d7-e053-2a95a90a43332020-12-03WarningsExact identifier
unii: C151H8M554
IbuprofenIBUPROFENProficient Rx LP8813a8a4-ebbd-4204-88a3-600a92ea91702020-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Food AdditivesIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,Newton Laboratories, Inc.9aefc830-329c-5e35-e053-2a95a90a6ffe2020-11-30WarningsExact identifier
unii: C151H8M554
Food AdditivesIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,Newton Laboratories, Inc.9af2d6f4-baa8-5da9-e053-2995a90a3dac2020-11-30WarningsExact identifier
unii: C151H8M554
Childrens IbuprofenIBUPROFENCVS Pharmacy60fd517d-608b-473e-8a44-eb98424599972020-10-22WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen IBIBUPROFENWINCO FOODS, LLC9d78644d-83c7-46d1-8156-0d76acb7c2992020-09-17WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen IBIBUPROFENWINCO FOODS, LLCee867519-227f-44ba-ba8b-2dbefcc9fc672020-09-17WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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