FDA.reportPublic FDA data

Childrens Motrin

Product NDC
50580-603
11-digit product format
505800603
Labeler code
50580
Product ID
50580-603_22ec9b80-0022-6006-e063-6394a90a80af
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Kenvue Brands LLC
Application
NDA020516
Marketing category
NDA
Marketing start
2016-01-25
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020516-001CHILDREN'S MOTRINIBUPROFEN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-16

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-16a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens MotrinIBUPROFENKenvue Brands LLC4f664479-f68c-464a-956d-25bb9f39c4cc2024-11-08WarningsExact identifier
application applno (NDA): 020516
application number: NDA020516
ndc (product): 50580-603
Childrens MotrinIBUPROFENKenvue Brands LLC152189e5-391c-42d3-a03b-c8364e2de6bf2024-11-08WarningsExact identifier
application applno (NDA): 020516
application number: NDA020516
Childrens MotrinIBUPROFENKenvue Brands LLC9e1cdef7-921f-4163-869c-6c062e31c5bb2024-11-01WarningsExact identifier
application applno (NDA): 020516
application number: NDA020516
Childrens MOTRINIBUPROFENKenvue Brands LLCf2609308-17bf-4bcb-84b2-d17f3fd359582024-11-01WarningsExact identifier
application applno (NDA): 020516
application number: NDA020516

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WK2XYI10QMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197803Internal RxNorm lookup
544393Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4f664479-f68c-464a-956d-25bb9f39c4ccAvailable on FDA.report

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
50580-603-04Childrens Motrin1 in 1 CARTONSUSPENSION110
50580-603-04Childrens Motrin120 mL in 1 BOTTLESUSPENSION12010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-603-04ML - Milliliter50580-603f2f8b9d9-b632-4fd8-b1a1-27e34171622612013-04-01

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-603CHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [KENVUE BRANDS LLC]10Current NDC, Legacy NDC, 2 package rows20241109_4f664479-f68c-464a-956d-25bb9f39c4cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN4f664479-f68c-464a-956d-25bb9f39c4cc10
544393Motrin Children 100 MG in 5 mL Oral SuspensionPSN4f664479-f68c-464a-956d-25bb9f39c4cc10
544393ibuprofen 20 MG/ML Oral Suspension [Motrin]SBD4f664479-f68c-464a-956d-25bb9f39c4cc10
197803ibuprofen 20 MG/ML Oral SuspensionSCD4f664479-f68c-464a-956d-25bb9f39c4cc10
544393Children's Motrin 100 MG per 5 ML Oral SuspensionSY4f664479-f68c-464a-956d-25bb9f39c4cc10
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY4f664479-f68c-464a-956d-25bb9f39c4cc10
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY4f664479-f68c-464a-956d-25bb9f39c4cc10
544393Motrin 20 MG/ML Oral SuspensionSY4f664479-f68c-464a-956d-25bb9f39c4cc10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-603-04505800603041 BOTTLE in 1 CARTON (50580-603-04) / 120 mL in 1 BOTTLE1 bottle2016-01-250000-00-00NoNoCurrent