Home NDC 50580-601 Childrens MOTRIN
Product NDC 50580-601
11-digit product format 505800601
Labeler code 50580
Product ID 50580-601_22ebcf8b-8b39-47f7-e063-6394a90a735b
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form SUSPENSION
Route ORAL
Labeler Kenvue Brands LLC
Application NDA020516
Marketing category NDA
Marketing start 1995-09-01
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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020516-001 CHILDREN'S MOTRIN IBUPROFEN 100MG/5ML SUSPENSION / ORAL RLD, RS 1995-06-16
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N020516-001 CHILDREN'S MOTRIN 100MG/5ML SUSPENSION / ORAL RLD, RS 1995-06-16 a50c72e98297…
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.
Additional Listing Data#
Finished product Yes
Brand name base Childrens MOTRIN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 100 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WK2XYI10QM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197803 Internal RxNorm lookup 544393 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Ibuprofen ACTIVE INGREDIENT WK2XYI10QM CHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 3 Ibuprofen ACTIVE MOIETY WK2XYI10QM CHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 3 acesulfame potassium INACTIVE INGREDIENT 23OV73Q5G9 CHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 3 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL CHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 3 D&C yellow no. 10 INACTIVE INGREDIENT 35SW5USQ3G CHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 3 FD&C red no. 40 INACTIVE INGREDIENT WZB9127XOA CHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 3 glycerin INACTIVE INGREDIENT PDC6A3C0OX CHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 3 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H CHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 3 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU CHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 3 sucrose INACTIVE INGREDIENT C151H8M554 CHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 3 water INACTIVE INGREDIENT 059QF0KO0R CHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 3 xanthan gum INACTIVE INGREDIENT TTV12P4NEE CHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-601 CHILDRENS MOTRIN (IBUPROFEN) SUSPENSION [KENVUE BRANDS LLC] 16 Current NDC, Legacy NDC, 11 package rows 20241103_f2609308-17bf-4bcb-84b2-d17f3fd35958.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50580-601-04 50580060104 120 mL in 1 BOTTLE, PLASTIC 120 ml Historical 50580-601-08 50580060108 2 CARTON in 1 PACKAGE (50580-601-08) / 1 BOTTLE, PLASTIC in 1 CARTON (50580-601-04) / 120 mL in 1 BOTTLE, PLASTIC 2 carton 2002-01-30 0000-00-00 No No Current 50580-601-20 50580060120 1 BOTTLE, PLASTIC in 1 CARTON (50580-601-20) / 120 mL in 1 BOTTLE, PLASTIC 2012-03-01 0000-00-00 No No Current 50580-601-21 50580060121 1 BOTTLE, PLASTIC in 1 CARTON (50580-601-21) / 120 mL in 1 BOTTLE, PLASTIC 2012-03-01 0000-00-00 No No Current 50580-601-22 50580060122 1 BOTTLE, PLASTIC in 1 CARTON (50580-601-22) / 30 mL in 1 BOTTLE, PLASTIC 2012-03-01 0000-00-00 No No Current 50580-601-25 50580060125 2 CARTON in 1 PACKAGE (50580-601-25) / 1 BOTTLE, PLASTIC in 1 CARTON / 120 mL in 1 BOTTLE, PLASTIC 2 carton 2012-07-10 0000-00-00 No No Current