FDA.reportPublic FDA data

Childrens Motrin

Product NDC
50580-184
11-digit product format
505800184
Labeler code
50580
Product ID
50580-184_21d440bd-8a6a-5109-e063-6394a90a0e8f
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Kenvue Brands LLC
Application
NDA020516
Marketing category
NDA
Marketing start
2001-09-01
Substance
IBUPROFEN
Active strength
100 mg/5mL
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Childrens Motrin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197803, 544393

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-184-01Childrens Motrin1 in 1 CARTONSUSPENSION116
50580-184-01Childrens Motrin240 mL in 1 BOTTLE, PLASTICSUSPENSION24016
50580-184-50Childrens Motrin120 mL in 1 BOTTLE, PLASTICSUSPENSION12016
50580-184-50Childrens Motrin1 in 1 CARTONSUSPENSION116
50580-184-51Childrens Motrin2 in 1 PACKAGESUSPENSION216
50580-184-51Childrens Motrin1 in 1 CARTONSUSPENSION116
50580-184-52Childrens Motrin1 in 1 CARTONSUSPENSION116
50580-184-52Childrens Motrin3 in 1 PACKAGESUSPENSION316

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-184-01ML - Milliliter50580-184caaf1f42-8d81-4ba5-881b-9388970c167f12024-04-05
50580-184-04ML - Milliliter50580-184ffebdb3b-7bbe-4eb8-9c01-a2d86a8a610812012-07-24
50580-184-50ML - Milliliter50580-18472ff8340-92b0-45d3-9bdf-86e42ec9772612014-06-03
50580-184-51ML - Milliliter50580-18485e8878f-8320-4267-8558-e42651140b3f12021-08-05
50580-184-52ML - Milliliter50580-1847da964f5-ec53-4b7a-b389-5df2eaa7bf4b12021-09-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IbuprofenACTIVE INGREDIENTWK2XYI10QMCHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
IbuprofenACTIVE MOIETYWK2XYI10QMCHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
acesulfame potassiumINACTIVE INGREDIENT23OV73Q5G9CHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLCHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXCHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HCHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUCHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
sucroseINACTIVE INGREDIENTC151H8M554CHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
waterINACTIVE INGREDIENT059QF0KO0RCHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
xanthan gumINACTIVE INGREDIENTTTV12P4NEECHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-184CHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [KENVUE BRANDS LLC]16Current NDC, Legacy NDC, 8 package rows20241103_9e1cdef7-921f-4163-869c-6c062e31c5bb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN9e1cdef7-921f-4163-869c-6c062e31c5bb16
544393Motrin Children 100 MG in 5 mL Oral SuspensionPSN9e1cdef7-921f-4163-869c-6c062e31c5bb16
544393ibuprofen 20 MG/ML Oral Suspension [Motrin]SBD9e1cdef7-921f-4163-869c-6c062e31c5bb16
197803ibuprofen 20 MG/ML Oral SuspensionSCD9e1cdef7-921f-4163-869c-6c062e31c5bb16
544393Children's Motrin 100 MG per 5 ML Oral SuspensionSY9e1cdef7-921f-4163-869c-6c062e31c5bb16
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY9e1cdef7-921f-4163-869c-6c062e31c5bb16
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY9e1cdef7-921f-4163-869c-6c062e31c5bb16
544393Motrin 20 MG/ML Oral SuspensionSY9e1cdef7-921f-4163-869c-6c062e31c5bb16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-184-01505800184011 BOTTLE, PLASTIC in 1 CARTON (50580-184-01) / 240 mL in 1 BOTTLE, PLASTIC2021-12-270000-00-00NoNoCurrent
50580-184-50505800184501 BOTTLE, PLASTIC in 1 CARTON (50580-184-50) / 120 mL in 1 BOTTLE, PLASTIC2012-02-280000-00-00NoNoCurrent
50580-184-51505800184512 CARTON in 1 PACKAGE (50580-184-51) > 1 BOTTLE, PLASTIC in 1 CARTON > 120 mL in 1 BOTTLE, PLASTIC2 carton2019-02-040000-00-00NoNoCurrent
50580-184-52505800184523 CARTON in 1 PACKAGE (50580-184-52) / 1 BOTTLE, PLASTIC in 1 CARTON / 120 mL in 1 BOTTLE, PLASTIC3 carton2021-05-030000-00-00NoNoCurrent