FDA.reportPublic FDA data

NDC 50580-198-01 - Motrin Infants

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
50580-198
Requested NDC
50580-198-01
Package NDCs from labels
50580-198-50, 50580-198-51, 50580-198-52, 50580-198-05, 50580-198-01
Manufacturer
Kenvue Brands LLC
Effective date
2026-05-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Motrin Infants - Kenvue Brands LLCKenvue Brands LLC2026-05-12HUMAN OTC DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-11Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50580-198-502024-01-30C16284748780-11030e365-3a5b-111a-e063-dadaa90a10e2Motrin ® Infants'
50580-198-512024-01-30C16284748780-11030e365-3a5b-111a-e063-dadaa90a10e2Motrin ® Infants'
50580-198-522024-01-30C16284748780-11030e365-3a5b-111a-e063-dadaa90a10e2Motrin ® Infants'

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-198-05MotrinInfants1 in 1 CARTONSUSPENSION/ DROPS117
50580-198-05MotrinInfants15 mL in 1 BOTTLESUSPENSION/ DROPS1517
50580-198-50MotrinInfants1 in 1 CARTONSUSPENSION/ DROPS117
50580-198-50MotrinInfants30 mL in 1 BOTTLESUSPENSION/ DROPS3017
50580-198-51MotrinInfants1 in 1 CARTONSUSPENSION/ DROPS117
50580-198-51MotrinInfants15 mL in 1 BOTTLESUSPENSION/ DROPS1517
50580-198-52MotrinInfants1 in 1 CARTONSUSPENSION/ DROPS117
50580-198-52MotrinInfants2 in 1 PACKAGESUSPENSION/ DROPS217

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-198MOTRIN INFANTS (IBUPROFEN) SUSPENSION/ DROPS [KENVUE BRANDS LLC]16Current NDC, Legacy NDC, 8 package rows20250124_c57f6ded-c0bd-45ae-823a-4c02ce334d98.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-198-01ML - Milliliter50580-198d1eaf9e2-d545-46c8-9cc4-a48ea0d1e84012013-02-11
50580-198-15ML - Milliliter50580-198c0d5db24-6cad-4ad9-8a71-bdf15b809b2412013-02-11
50580-198-50ML - Milliliter50580-1986d73a606-d026-4d75-9745-635c94729bae12015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IbuprofenACTIVE INGREDIENTWK2XYI10QMMOTRIN INFANTS (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]3
IbuprofenACTIVE MOIETYWK2XYI10QMMOTRIN INFANTS (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]3
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLMOTRIN INFANTS (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]3
caramelINACTIVE INGREDIENTT9D99G2B1RMOTRIN INFANTS (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]3
glycerinINACTIVE INGREDIENTPDC6A3C0OXMOTRIN INFANTS (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]3
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HMOTRIN INFANTS (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]3
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUMOTRIN INFANTS (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]3
sorbitolINACTIVE INGREDIENT506T60A25RMOTRIN INFANTS (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]3
sucroseINACTIVE INGREDIENTC151H8M554MOTRIN INFANTS (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]3
waterINACTIVE INGREDIENT059QF0KO0RMOTRIN INFANTS (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]3
xanthan gumINACTIVE INGREDIENTTTV12P4NEEMOTRIN INFANTS (IBUPROFEN) SUSPENSION/ DROPS [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]3

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 3 of 88 · 1,749 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ibuprofen PMDIPHENHYDRAMINE CITRATE, IBUPROFENWALMART INC. (see also Equate)d86151b6-d5c5-4d93-9cfd-43ab7ad0443a2026-08-12WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAiPing Pharmaceutical, Inc.3e131710-2579-446e-8076-f602ecea813f2026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
AdaptopathADENOSINUM CYCLOPHOSPHORICUM, ALPHA-LIPOICUM ACIDUM, ARGENTUM METALLICUM, AVENA SATIVA, CAPSICUM ANNUUM, CITRICUM ACIDUM, COENZYME A, CUPRUM METALLICUM, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYPOTHALAMUS (BOVINE), IODIUM, LEDUM PALUSTRE, MANGANUM ACETICUM, NADIDUM, NATRUM CARBONICUM, OLEUM MORRHUAE, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, RIBOFLAVINUM, SELENIUM METALLICUM SEPIA, SILICEA, THIAMINUM HYDROCHLORICUM, THYROIDINUM (BOVINE), VANADIUM METALLICUMEnergetix Corporation41234598-0cb5-41c2-bfbe-1c15ee9bf5022026-08-11WarningsExact identifier
unii: XF417D3PSL
Aller-Chord AALFALFA, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, BRYONIA (ALBA), CITRICUM ACIDUM, COUMARINUM, EUPHRASIA OFFICINALIS, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, JUNIPERUS COMMUNIS, MUCOSA NASALIS SUIS, NATRUM SULPHURICUM, PHOSPHORUS, POTHOS FOETIDUS, PULSATILLA (VULGARIS), SOLIDAGO VIRGAUREA, SULPHUR, TANACETUM VULGARE, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSEEnergetix Corporation09e89c92-112d-4320-9df5-b9f938bb90952026-08-11WarningsExact identifier
unii: XF417D3PSL
Hepatic-ToneCARDUUS MARIANUS, CEANOTHUS AMERICANUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CITRICUM ACIDUM, CYSTEINUM, HEPAR SUIS, LEPTANDRA VIRGINICA, MAGNESIA MURIATICA, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, QUASSIA (AMARA), TARAXACUM OFFICINALEEnergetix Corporationd5f61f13-7e9f-4e46-8ad8-0336f36288df2026-08-11WarningsExact identifier
unii: XF417D3PSL
Isopathic Phenolic RingsHOMEOPATHIC LIQUIDEnergetix Corporation98a7ca26-ccb7-43c7-bd65-892fcbacc8822026-08-11WarningsExact identifier
unii: C151H8M554
unii: XF417D3PSL
Lipo-ChordACETICUM AC, ACETYLSAL AC, ADRENOCORTICOTROPHIN, ALUMINA, ARSENICUM ALB, BORAGO, CEANOTHUS, CHELIDONIUM MAJ, CHIONANTHUS, CHLORAMPHENICOLUM, CHLORPROMAZINUM, CHOLESTERINUM, CORTISONE ACETICUM, DAMIANA, FOLLICULINUM, FUMARICUM AC, KALI IOD, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, OLEUM MORRHUAE, PETROLEUM, PHENACETINUM, PHOSPHORICUM AC, PHOSPHORUS, PLUMB MET, SACCHARUM OFF, SILICEA, TARAXACUM, THYROIDINUM.Energetix Corporation5c83cbd5-46fb-48a0-a739-ff9c81e7129c2026-08-11WarningsExact identifier
unii: C151H8M554
MetabopathADENOSINUM CYCLOPHOSPHORICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, BERBERIS VULGARIS, CITRICUM ACIDUM, COENZYME A, DNA, FUMARICUM ACIDUM, GLYCYRRHIZA GLABRA, HEPAR SULPHURIS CALCAREUM, LAPPA MAJOR, MAGNESIA PHOSPHORICA, MANGANUM ACETICUM, NADIDUM, NATRUM MURIATICUM, NATRUM OXALACETICUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PULSATILLA, PYRIDOXINUM HYDROCHLORICUM, RHAMNUS PURSHIANA, RIBOFLAVINUM, RNA, SILICEA, SUCCINICUM ACIDUM, SULPHUR, THIAMINUM HYDROCHLORICUM,Energetix Corporation58bfe670-d308-45a2-8046-7897b62214522026-08-11WarningsExact identifier
unii: XF417D3PSL
INFANTS IBUPROFENIBUPROFENAmazon.com Services LLC8588617a-d4b8-4ab5-8b87-30e6f1121cc32026-08-10WarningsExact identifier
rxcui: 204442
unii: WK2XYI10QM
IbuprofenIBUPROFENShield Pharmaceuticals Corp22102461-0196-4ef0-aef4-66997d74d1182026-08-10WarningsExact identifier
unii: WK2XYI10QM
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Ibuprofen minisIBUPROFENWalgreens6d1d131d-0741-4a75-8383-9322f4f3faab2026-08-06WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENShield Pharmaceuticals Corp216e5600-56b4-44b0-88b7-69adfb2458022026-08-06WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCOSTCO WHOLESALE CORPORATION4b8ad98e-de76-4f49-3b89-01e9dd5cde162026-08-06WarningsExact identifier
unii: WK2XYI10QM
Dye Free IbuprofenIBUPROFENWalgreen Companyd3d093f9-207a-40d4-a7be-c6b5a544a0a72026-08-06WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENP & L Development, LLC159b68b7-54e5-4f83-b632-f49e7b4b14a52026-08-05WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENWalgreen Companyc118b290-f821-4e73-906e-8a93edaf34e42026-08-05WarningsExact identifier
unii: WK2XYI10QM
Dye Free IbuprofenIBUPROFENWalgreen Company8944a0e8-2928-4494-915f-d1e0a6d4bf5c2026-08-04WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.560e4e05-21e0-4b2a-ab2f-872b5dbb39012026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
CVS GlycerinGLYCERIN SUPPOISITORYCVS Pharmacy, Incca6d13db-60e8-4fcc-b7b3-3eb280b8c4352026-08-04WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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