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 2 of 88 · 1,749 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENGobrands, Inc. (Goodnow)04e1b176-b74a-413e-a8e1-dd3764b9aa8b2026-09-01WarningsExact identifier
unii: WK2XYI10QM
equaline dual action pain relieverACETAMINOPHEN, IBUPROFENUnited Natural Foods, Inc. dba UNFIae0dc3f1-ee6f-4347-af5d-70f45dd68bdb2026-08-27WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.2572ed69-d5a7-4513-a202-aca3230e7ec52026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
foster and thrive dual actionACETAMINOPHEN, IBUPROFENStrategic Sourcing Services LLCf970d423-1d92-40c0-8358-91d1f963505c2026-08-26WarningsExact identifier
unii: WK2XYI10QM
Pain RelieverACETAMINOPHEN, IBUPROFENCVS Pharmacy9126e680-d5ff-4189-9f9a-d797822ce6702026-08-26WarningsExact identifier
unii: WK2XYI10QM
Leader Dual Action Pain RelieverACETAMINOPHEN, IBUPROFENCardinal Health 110, LLC. dba Leader2bb1f616-48af-4fe1-9aa9-32fcb2dba50c2026-08-26WarningsExact identifier
unii: WK2XYI10QM
dual pain relieverACETAMINOPHEN, IBUPROFENWalgreen Company5cb3b0b4-5b47-4ed4-a5e3-f14dbbcb46df2026-08-26WarningsExact identifier
unii: WK2XYI10QM
Infants IbuprofenIBUPROFENWalgreens3bbbe142-a00c-404b-a116-81ad730ea1302026-08-25WarningsExact identifier
rxcui: 204442
unii: WK2XYI10QM
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
IbuprofenIBUPROFENMajor Pharmaceuticalsba86e936-ef72-43e5-aebf-f2c788fe22662026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
CombogesicACETAMINOPHEN AND IBUPROFENPreferred Pharmaceuticals Inc.f3cee991-19ef-4a1c-bb14-cbc8b6f327762026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENSafeway, Inc.57f06daf-690d-44a7-95a5-4687329497502026-08-19WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENNuCare Pharmaceuticals,Inc.59554a62-3a9a-c0f3-e063-6294a90ad3fd2026-08-18WarningsExact identifier
unii: WK2XYI10QM
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: PDC6A3C0OX
CHILDRENS IBUPROFENIBUPROFENAmazon.com Services LLC0865fe8a-df81-4ae4-8bed-29a022ba164f2026-08-17WarningsExact identifier
unii: WK2XYI10QM
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
BM BM164 DROPSARUM TRYPH, CAUSTICUM, BALSAMUM PERU, HELONIAS DIO, ACID PHOS, GLYCERINUM, EQUISETUMBM Private Limited5902770f-eb01-d099-e063-6394a90ad3eb2026-08-14WarningsExact identifier
unii: PDC6A3C0OX
CHILDRENS IBUPROFENIBUPROFENAmazon.com Services LLC5ba08c30-7eb9-433b-b763-9288f4dd10122026-08-12WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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