childrens motrin

Generic: ibuprofen

Labeler: kenvue brands llc
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name childrens motrin
Generic Name ibuprofen
Labeler kenvue brands llc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

ibuprofen 100 mg/5mL

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-601
Product ID 50580-601_22ebcf8b-8b39-47f7-e063-6394a90a735b
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA020516
Listing Expiration 2026-12-31
Marketing Start 1995-09-01

Pharmacologic Class

Established (EPC)
nonsteroidal anti-inflammatory drug [epc]
Mechanism of Action
cyclooxygenase inhibitors [moa]
Chemical Structure
anti-inflammatory agents, non-steroidal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50580601
Hyphenated Format 50580-601

Supplemental Identifiers

RxCUI
197803 544393
UPC
0300450192011
UNII
WK2XYI10QM
NUI
N0000000160 M0001335 N0000175722

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name childrens motrin (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number NDA020516 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 2 CARTON in 1 PACKAGE (50580-601-08) / 1 BOTTLE, PLASTIC in 1 CARTON (50580-601-04) / 120 mL in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (50580-601-20) / 120 mL in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (50580-601-21) / 120 mL in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (50580-601-22) / 30 mL in 1 BOTTLE, PLASTIC
  • 2 CARTON in 1 PACKAGE (50580-601-25) / 1 BOTTLE, PLASTIC in 1 CARTON / 120 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (5)

50580-601-08 2 CARTON in 1 PACKAGE (50580-601-08) / 1 BOTTLE, PLASTIC in 1 CARTON (50580-601-04) / 120 mL in 1 BOTTLE, PLASTIC 50580-601-20 1 BOTTLE, PLASTIC in 1 CARTON (50580-601-20) / 120 mL in 1 BOTTLE, PLASTIC 50580-601-21 1 BOTTLE, PLASTIC in 1 CARTON (50580-601-21) / 120 mL in 1 BOTTLE, PLASTIC 50580-601-22 1 BOTTLE, PLASTIC in 1 CARTON (50580-601-22) / 30 mL in 1 BOTTLE, PLASTIC 50580-601-25 2 CARTON in 1 PACKAGE (50580-601-25) / 1 BOTTLE, PLASTIC in 1 CARTON / 120 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

ibuprofen (100 mg/5mL)

Linked Drug Pages (1)

Childrens MOTRIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "22ebcf8b-8b39-47f7-e063-6394a90a735b", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0300450192011"], "unii": ["WK2XYI10QM"], "rxcui": ["197803", "544393"], "spl_set_id": ["f2609308-17bf-4bcb-84b2-d17f3fd35958"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 CARTON in 1 PACKAGE (50580-601-08)  / 1 BOTTLE, PLASTIC in 1 CARTON (50580-601-04)  / 120 mL in 1 BOTTLE, PLASTIC", "package_ndc": "50580-601-08", "marketing_start_date": "20020130"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (50580-601-20)  / 120 mL in 1 BOTTLE, PLASTIC", "package_ndc": "50580-601-20", "marketing_start_date": "20120301"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (50580-601-21)  / 120 mL in 1 BOTTLE, PLASTIC", "package_ndc": "50580-601-21", "marketing_start_date": "20120301"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (50580-601-22)  / 30 mL in 1 BOTTLE, PLASTIC", "package_ndc": "50580-601-22", "marketing_start_date": "20120301"}, {"sample": false, "description": "2 CARTON in 1 PACKAGE (50580-601-25)  / 1 BOTTLE, PLASTIC in 1 CARTON / 120 mL in 1 BOTTLE, PLASTIC", "package_ndc": "50580-601-25", "marketing_start_date": "20120710"}], "brand_name": "Childrens MOTRIN", "product_id": "50580-601_22ebcf8b-8b39-47f7-e063-6394a90a735b", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "50580-601", "generic_name": "Ibuprofen", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens MOTRIN", "active_ingredients": [{"name": "IBUPROFEN", "strength": "100 mg/5mL"}], "application_number": "NDA020516", "marketing_category": "NDA", "marketing_start_date": "19950901", "listing_expiration_date": "20261231"}