FDA.reportPublic FDA data

NDC 50580-601-04 - Childrens MOTRIN

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
50580-601
Requested NDC
50580-601-04
Package NDCs from labels
50580-601-04, 50580-601-08, 50580-601-21, 50580-601-22, 50580-601-20, 50580-601-25
Manufacturer
Kenvue Brands LLC
Effective date
2024-11-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Childrens MOTRIN - Kenvue Brands LLCKenvue Brands LLC2024-11-01HUMAN OTC DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50580-601-082024-02-06Children's MOTRIN
50580-601-202024-02-06Children's MOTRIN
50580-601-212024-02-06Children's MOTRIN
50580-601-222024-02-06Children's MOTRIN
50580-601-252024-02-06Children's MOTRIN
50580-601-082024-01-30Children's MOTRIN
50580-601-202024-01-30Children's MOTRIN
50580-601-212024-01-30Children's MOTRIN
50580-601-222024-01-30Children's MOTRIN
50580-601-252024-01-30Children's MOTRIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-601-04Childrens MOTRIN120 mL in 1 BOTTLE, PLASTICSUSPENSION12016
50580-601-04Childrens MOTRIN1 in 1 CARTONSUSPENSION116
50580-601-08Childrens MOTRIN2 in 1 PACKAGESUSPENSION216
50580-601-20Childrens MOTRIN1 in 1 CARTONSUSPENSION116
50580-601-20Childrens MOTRIN120 mL in 1 BOTTLE, PLASTICSUSPENSION12016
50580-601-21Childrens MOTRIN1 in 1 CARTONSUSPENSION116
50580-601-21Childrens MOTRIN120 mL in 1 BOTTLE, PLASTICSUSPENSION12016
50580-601-22Childrens MOTRIN30 mL in 1 BOTTLE, PLASTICSUSPENSION3016
50580-601-22Childrens MOTRIN1 in 1 CARTONSUSPENSION116
50580-601-25Childrens MOTRIN2 in 1 PACKAGESUSPENSION216
50580-601-25Childrens MOTRIN1 in 1 CARTONSUSPENSION116

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-601CHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [KENVUE BRANDS LLC]16Current NDC, Legacy NDC, 11 package rows20241103_f2609308-17bf-4bcb-84b2-d17f3fd35958.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-601-02ML - Milliliter50580-60142731c07-20ff-472c-8853-3f36b0bfceef12012-07-24
50580-601-04ML - Milliliter50580-601cf7d0d9a-3bb6-48e5-b268-751d68acde5112012-07-24
50580-601-08ML - Milliliter50580-60115da2c10-1fbc-41d3-8de3-74f24d8e33a112012-07-24
50580-601-20ML - Milliliter50580-601f2880dc1-37a2-4bfb-bf72-d9956f8f76c312012-07-24
50580-601-21ML - Milliliter50580-601477aaf3e-399a-4e4d-baae-7b3694b88bb012013-03-03
50580-601-22ML - Milliliter50580-6016cfb1465-d497-40d2-8252-f05ba72a9fd312016-06-14
50580-601-50ML - Milliliter50580-601983ed4a0-bf23-439a-a289-734fe98b01e512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IbuprofenACTIVE INGREDIENTWK2XYI10QMCHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]3
IbuprofenACTIVE MOIETYWK2XYI10QMCHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]3
acesulfame potassiumINACTIVE INGREDIENT23OV73Q5G9CHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]3
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLCHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]3
D&C yellow no. 10INACTIVE INGREDIENT35SW5USQ3GCHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]3
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOACHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]3
glycerinINACTIVE INGREDIENTPDC6A3C0OXCHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]3
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HCHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]3
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUCHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]3
sucroseINACTIVE INGREDIENTC151H8M554CHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]3
waterINACTIVE INGREDIENT059QF0KO0RCHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]3
xanthan gumINACTIVE INGREDIENTTTV12P4NEECHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [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 1 of 90 · 1,781 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dual actionACETAMINOPHEN, IBUPROFENRite Aid Corporation54b08d24-d5e9-4111-9d97-329896e8309d2026-09-09WarningsExact identifier
unii: WK2XYI10QM
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
IbuprofenIBUPROFENLidl US LLC0ca02f8b-4413-4e7c-a67b-8c67c53e13432026-09-09WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENGOODSENSE596a1007-08ea-00ec-e063-6394a90a5eb22026-09-09WarningsExact identifier
unii: WK2XYI10QM
ibuprofen childrensIBUPROFENRite Aid Corporationc6e68886-edcb-414d-9cba-0d97772ef8b62026-09-09WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
Ibuprofen minisIBUPROFENThe Kroger Co.15709fa7-114b-453c-b63d-f1c4f28f0f952026-09-08WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.2144eff0-d7ab-486d-b116-a4ff3ae2afe22026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
unii: PDC6A3C0OX
IbuprofenIBUPROFENThe Kroger Co.a7789f7f-3356-463b-9fd7-2d7f7eba27992026-09-08WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENAmazon.com Services LLC90659e83-d989-46a5-9680-3a4f616125112026-09-04WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENDirect_Rx40071818-5bf0-095b-e063-6294a90ad58a2026-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
unii: PDC6A3C0OX
IbuprofenIBUPROFENChain Drug Marketing Association, Inc.8d518a08-486a-4d11-b042-27fc1e6060c92026-09-03WarningsExact identifier
unii: WK2XYI10QM
IBUPROFEN Immediate ReleaseIBUPROFENStrides Pharma Inca5dd275f-f388-44ec-8297-74430a742d522026-09-02Boxed warning, WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.0fa4cd66-66ad-4ec9-b38c-6b5840df39df2026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Ibuprofen Immediate ReleaseIBUPROFENStrides Pharma Incebcc4da3-d0f6-4e40-99b5-e88310ea4a5b2026-09-02Boxed warning, WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.99730c4a-d2ee-46f5-91f4-a15cbaace40d2026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.3a38add6-a114-4e18-836c-3bfc727db2312026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.404df13d-4ada-4324-9eed-e21f5d5043a42026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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