NDC 59368-003-01 - 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
Requested NDC
59368-003-01
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 67 of 88 · 1,758 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FleetGLYCERINC.B. Fleet Company, Inc.381f4179-0c3b-41f8-927c-c88534ebe06d2024-05-06WarningsExact identifier
unii: PDC6A3C0OX
REFL HSADENOSINUM TRIPHOSPHORICUM DINATRUM, NADIDUM, ARGENTUM NITRICUM, IPECACUANHA, ROBINIA PSEUDOACACIA, SULPHUR, ORIGANUM VULGARE, DUODENUM (SUIS), ESOPHAGUS (SUIS), FUNICULUS UMBILICALIS SUIS, STOMACH (SUIS), NUX VOMICA, COUMARINUM, ERYTHRAEA CENTAURIUM, PANCREAS SUIS, MURIATICUM ACIDUM, CITRICUM ACIDUM, FORMICUM ACIDUM, SARCOLACTICUM ACIDUM, COENZYME A, PROTEUS (MORGANI)Deseret Biologicals, Inc.83249aee-f58b-442d-9187-6de0cf070e4d2024-04-29WarningsExact identifier
unii: XF417D3PSL
GlucoregASCORBICUM ACIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SARCOLACTICUM ACIDUM, THIAMINUM HYDROCHLORICUM, DHEA (DEHYDROEPIANDROSTERONE), ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-LIPOICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, NADIDUM, PANTOTHENIC ACID, ACETALDEHYDE, INSULINUM (SUIS), INSULINUM (HUMAN), HEPAR SUIS, PANCREAS SUIS, PHLORIDZINUM, ALLOXANUM, BERBERIS VULGARIS, CARCINOSIN, LYCOPODIUM CLAVATUM, MOMORDICA BALSAMINA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SYZYGIUM JAMBOLANUM,Deseret Biologicals, Inc.c77d0682-a000-4783-a91c-d4e205c347742024-04-29WarningsExact identifier
unii: XF417D3PSL
IBUPROFEN 100IBUPROFENJHK Inc dba American Safety & First Aid218f6df9-dd04-45b6-8a45-3276691abee22024-04-25WarningsExact identifier
unii: WK2XYI10QM
ADVIL DUAL ACTION WITH ACETAMINOPHEN Back PainIBUPROFEN, ACETAMINOPHENHaleon US Holdings LLCacaa9806-e552-44f2-a680-b8bb64c49e1f2024-04-24WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen 200 mg and Diphenhydramine Citrate 38 mgIBUPROFEN, DIPHENHYDRAMINE CITRATEPLD Acquisitions LLC DBA Avma Pharma Solutionsa7d729bf-6d7a-415a-a414-cae0ba6d00632024-04-24WarningsExact identifier
unii: WK2XYI10QM
IBUPROFEN AND FAMOTIDINEIBUPROFEN AND FAMOTIDINEAdvanced Rx Pharmacy of Tennessee, LLC16c8b0db-37d0-99d9-e063-6394a90ac31b2024-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
GlyregACETICUM ACIDUM, CACAO, MAGNESIA SULPHURICA, NATRUM SULPHURICUM, VERBASCUM THAPSUS, GLANDULA SUPRARENALIS SUIS, PANCREAS SUIS, CORTISONE ACETICUM, THYROIDINUM (SUIS), IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, RANUNCULUS BULBOSUS, SACCHARUM OFFICINALE, VANADIUM METALLICUM, ZINCUM METALLICUM, CHROMIUM ACIDUM, CULEX MUSCADeseret Biologicals, Inc28e670ca-ed35-4256-af20-74c25dc180992024-04-23WarningsExact identifier
unii: C151H8M554
PEMF OptimizerAQUA SULIS, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, LAPIS ALBUS, MANGANUM METALLICUM VANADIUM METALLICUM VISCUM ALBUM, ZINCUM METALLICUMDeseret Biologicals, Inc.97d57469-4c5b-4d3f-9398-3a1a6617a6492024-04-23WarningsExact identifier
unii: 059QF0KO0R
JUNIOR STRENGTH ADVILIBUPROFENHaleon US Holdings LLC5ed0d404-c54d-b05f-578a-d2730e8a78ee2024-04-22WarningsExact identifier
unii: WK2XYI10QM
ADVIL DUAL ACTION WITH ACETAMINOPHENIBUPROFEN, ACETAMINOPHENNavajo Manufacturing Company Inc.bd0d7812-4e42-b533-e053-2995a90ae1f92024-04-15WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENKroger Companybc178013-ab2e-04f5-e053-2995a90a1ed42024-04-13WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFEN TABLETS USP, 200MGKROGER COMPANY0fbe42d0-b5f2-0780-e063-6394a90a4ecb2024-04-13WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENKROGER COMPANY0fbe42d0-b5f0-0780-e063-6394a90a4ecb2024-04-13WarningsExact identifier
unii: WK2XYI10QM
dg health ibuprofenIBUPROFENDolgencorp Incb514b589-d965-4a21-91b3-fab4019e9d962024-04-12WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENH E Be00acbc0-352e-4ba1-8433-18a3079f67432024-04-12WarningsExact identifier
unii: WK2XYI10QM
Sterile WaterWATERHikma Pharmaceuticals USA Inc.78ef7ad3-451d-43d0-a9b6-5cf0aadca0032024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Infants IbuprofenIBUPROFENAurohealth LLC2a48af51-23e2-4fec-a76b-eef1611750f52024-04-10WarningsExact identifier
unii: WK2XYI10QM
Sterile WaterWATERB. Braun Medical Inc.8fc8d87a-3951-4ac5-97df-c161ffc904752024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ADVIL PMDIPHENHYDRAMINE CITRATE AND IBUPROFENHaleon US Holdings LLC658fc201-47c9-6a6d-8af9-6208298d43b42024-04-08WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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