infants advil

Generic: ibuprofen

Labeler: haleon us holdings llc
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name infants advil
Generic Name ibuprofen
Labeler haleon us holdings llc
Dosage Form SUSPENSION/ DROPS
Routes
ORAL
Active Ingredients

ibuprofen 50 mg/1.25mL

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0573-0191
Product ID 0573-0191_9f156faa-6bf8-483c-837d-050e40ec0cc5
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA020812
Listing Expiration 2026-12-31
Marketing Start 1998-01-30

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 05730191
Hyphenated Format 0573-0191

Supplemental Identifiers

RxCUI
204442 731531
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 advil (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number NDA020812 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1.25mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (0573-0191-20) / 15 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (0573-0191-22) / 15 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (0573-0191-50) / 30 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (0573-0191-75) / 22.5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (4)

0573-0191-20 1 BOTTLE, DROPPER in 1 CARTON (0573-0191-20) / 15 mL in 1 BOTTLE, DROPPER 0573-0191-22 1 BOTTLE, DROPPER in 1 CARTON (0573-0191-22) / 15 mL in 1 BOTTLE, DROPPER 0573-0191-50 1 BOTTLE, DROPPER in 1 CARTON (0573-0191-50) / 30 mL in 1 BOTTLE, DROPPER 0573-0191-75 1 BOTTLE, DROPPER in 1 CARTON (0573-0191-75) / 22.5 mL in 1 BOTTLE, DROPPER

Ingredients (1)

ibuprofen (50 mg/1.25mL)

Linked Drug Pages (1)

INFANTS ADVIL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9f156faa-6bf8-483c-837d-050e40ec0cc5", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["204442", "731531"], "spl_set_id": ["db5ed801-7a7e-3c83-0172-77f914daaa5a"], "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": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0573-0191-20)  / 15 mL in 1 BOTTLE, DROPPER", "package_ndc": "0573-0191-20", "marketing_start_date": "19980130"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0573-0191-22)  / 15 mL in 1 BOTTLE, DROPPER", "package_ndc": "0573-0191-22", "marketing_start_date": "20140130"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0573-0191-50)  / 30 mL in 1 BOTTLE, DROPPER", "package_ndc": "0573-0191-50", "marketing_start_date": "19980130"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0573-0191-75)  / 22.5 mL in 1 BOTTLE, DROPPER", "package_ndc": "0573-0191-75", "marketing_start_date": "19980130"}], "brand_name": "INFANTS ADVIL", "product_id": "0573-0191_9f156faa-6bf8-483c-837d-050e40ec0cc5", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "0573-0191", "generic_name": "ibuprofen", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "INFANTS ADVIL", "active_ingredients": [{"name": "IBUPROFEN", "strength": "50 mg/1.25mL"}], "application_number": "NDA020812", "marketing_category": "NDA", "marketing_start_date": "19980130", "listing_expiration_date": "20261231"}