infants motrin

Generic: ibuprofen

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

Drug Facts

Product Profile

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

ibuprofen 50 mg/1.25mL

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-100
Product ID 50580-100_2bcd0083-0ce4-1d04-e063-6294a90a8b97
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA020603
Listing Expiration 2026-12-31
Marketing Start 2004-06-01

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 50580100
Hyphenated Format 50580-100

Supplemental Identifiers

RxCUI
204442 854762
UPC
0300450524157
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 infants motrin (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number NDA020603 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1.25mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (50580-100-18) / 15 mL in 1 BOTTLE
source: ndc

Packages (1)

50580-100-18 1 BOTTLE in 1 CARTON (50580-100-18) / 15 mL in 1 BOTTLE

Ingredients (1)

ibuprofen (50 mg/1.25mL)

Linked Drug Pages (1)

Infants Motrin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2bcd0083-0ce4-1d04-e063-6294a90a8b97", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0300450524157"], "unii": ["WK2XYI10QM"], "rxcui": ["204442", "854762"], "spl_set_id": ["c2302bfe-b367-4867-b803-29f066a42dc7"], "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": "1 BOTTLE in 1 CARTON (50580-100-18)  / 15 mL in 1 BOTTLE", "package_ndc": "50580-100-18", "marketing_start_date": "20120515"}], "brand_name": "Infants Motrin", "product_id": "50580-100_2bcd0083-0ce4-1d04-e063-6294a90a8b97", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "50580-100", "generic_name": "Ibuprofen", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Infants Motrin", "active_ingredients": [{"name": "IBUPROFEN", "strength": "50 mg/1.25mL"}], "application_number": "NDA020603", "marketing_category": "NDA", "marketing_start_date": "20040601", "listing_expiration_date": "20261231"}