FDA.reportPublic FDA data

Motrin

Product NDC
50580-198
11-digit product format
505800198
Labeler code
50580
Product ID
50580-198_519a1a5f-e816-0d56-e063-6294a90a337d
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION/ DROPS
Route
ORAL
Labeler
Kenvue Brands LLC
Application
NDA020603
Marketing category
NDA
Marketing start
2001-09-01
Substance
IBUPROFEN
Active strength
50 mg/1.25mL
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Motrin
Brand name suffix
Infants
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN50 mg/1.25mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui204442, 854762

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204442ibuprofen 50 MG in 1.25 mL Oral SuspensionPSNc57f6ded-c0bd-45ae-823a-4c02ce334d9817
854762Motrin Infant Drops Concentrated 50 MG in 1.25 mL Oral SuspensionPSNc57f6ded-c0bd-45ae-823a-4c02ce334d9817
854762ibuprofen 40 MG/ML Oral Suspension [Motrin]SBDc57f6ded-c0bd-45ae-823a-4c02ce334d9817
204442ibuprofen 40 MG/ML Oral SuspensionSCDc57f6ded-c0bd-45ae-823a-4c02ce334d9817
204442ibuprofen 50 MG per 1.25 ML Oral SuspensionSYc57f6ded-c0bd-45ae-823a-4c02ce334d9817
204442ibuprofen 50 MG per 1.25 ML Oral Suspension DropsSYc57f6ded-c0bd-45ae-823a-4c02ce334d9817
854762Infants' Motrin 40 MG/ML Oral SuspensionSYc57f6ded-c0bd-45ae-823a-4c02ce334d9817
854762Motrin 40 MG/ML Oral SuspensionSYc57f6ded-c0bd-45ae-823a-4c02ce334d9817
854762Motrin Infant Drops 50 MG per 1.25 ML Oral SuspensionSYc57f6ded-c0bd-45ae-823a-4c02ce334d9817

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-198-05505800198051 BOTTLE in 1 CARTON (50580-198-05) / 15 mL in 1 BOTTLE1 bottle2026-06-080Current
50580-198-50505800198501 BOTTLE in 1 CARTON (50580-198-50) / 30 mL in 1 BOTTLE1 bottle2012-06-080000-00-00NoNoCurrent
50580-198-51505800198511 BOTTLE in 1 CARTON (50580-198-51) > 15 mL in 1 BOTTLE1 bottle2012-06-080000-00-00NoNoCurrent
50580-198-52505800198522 CARTON in 1 PACKAGE (50580-198-52) > 1 BOTTLE in 1 CARTON > 30 mL in 1 BOTTLE2 carton2012-06-080000-00-00NoNoCurrent