advil dual action with acetaminophen (0573-0147)

Drug Facts

Product Profile

Brand Name advil dual action with acetaminophen

Generic Name ibuprofen, acetaminophen

Labeler haleon us holdings llc

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

acetaminophen 250 mg/1, ibuprofen 125 mg/1

Manufacturer

Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0573-0147

Product ID 0573-0147_440b1444-9b6d-44c2-8ec4-dbb66ebb5025

Product Type HUMAN OTC DRUG

Marketing Category NDA

Application Number NDA211733

Listing Expiration 2026-12-31

Marketing Start 2020-07-27

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 05730147

Hyphenated Format 0573-0147

Supplemental Identifiers

RxCUI

2387532

UNII

362O9ITL9D 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 advil dual action with acetaminophen (source: ndc)

Generic Name ibuprofen, acetaminophen (source: ndc)

Application Number NDA211733 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

250 mg/1
125 mg/1

source: ndc

Packaging

8 TABLET, FILM COATED in 1 BOTTLE (0573-0147-09)
1 BOTTLE in 1 CARTON (0573-0147-18) / 18 TABLET, FILM COATED in 1 BOTTLE
1 BOTTLE in 1 CARTON (0573-0147-24) / 24 TABLET, FILM COATED in 1 BOTTLE
1 BOTTLE in 1 CARTON (0573-0147-36) / 36 TABLET, FILM COATED in 1 BOTTLE
1 BOTTLE in 1 CARTON (0573-0147-72) / 72 TABLET, FILM COATED in 1 BOTTLE
1 BOTTLE in 1 CARTON (0573-0147-86) / 216 TABLET, FILM COATED in 1 BOTTLE
1 BOTTLE in 1 CARTON (0573-0147-90) / 90 TABLET, FILM COATED in 1 BOTTLE
3000 POUCH in 1 CASE (0573-0147-91) / 2 TABLET, FILM COATED in 1 POUCH
1 BOTTLE in 1 CARTON (0573-0147-93) / 162 TABLET, FILM COATED in 1 BOTTLE
1 BOTTLE in 1 CARTON (0573-0147-94) / 144 TABLET, FILM COATED in 1 BOTTLE
50 POUCH in 1 CARTON (0573-0147-95) / 2 TABLET, FILM COATED in 1 POUCH
240 TABLET, FILM COATED in 1 BOTTLE (0573-0147-97)

source: ndc

Packages (12)

Ingredients (2)

acetaminophen (250 mg/1) ibuprofen (125 mg/1)

Linked Drug Pages (1)

ADVIL DUAL ACTION WITH ACETAMINOPHEN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "440b1444-9b6d-44c2-8ec4-dbb66ebb5025", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["362O9ITL9D", "WK2XYI10QM"], "rxcui": ["2387532"], "spl_set_id": ["f5ea858e-76d9-4777-b3dc-5d614f66d485"], "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": "8 TABLET, FILM COATED in 1 BOTTLE (0573-0147-09)", "package_ndc": "0573-0147-09", "marketing_start_date": "20230515"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0573-0147-18)  / 18 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0573-0147-18", "marketing_start_date": "20200727"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0573-0147-24)  / 24 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0573-0147-24", "marketing_start_date": "20210906"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0573-0147-36)  / 36 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0573-0147-36", "marketing_start_date": "20200727"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0573-0147-72)  / 72 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0573-0147-72", "marketing_start_date": "20200727"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0573-0147-86)  / 216 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0573-0147-86", "marketing_start_date": "20200727"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0573-0147-90)  / 90 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0573-0147-90", "marketing_start_date": "20240408"}, {"sample": false, "description": "3000 POUCH in 1 CASE (0573-0147-91)  / 2 TABLET, FILM COATED in 1 POUCH", "package_ndc": "0573-0147-91", "marketing_start_date": "20230515"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0573-0147-93)  / 162 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0573-0147-93", "marketing_start_date": "20240409"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0573-0147-94)  / 144 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0573-0147-94", "marketing_start_date": "20200727"}, {"sample": false, "description": "50 POUCH in 1 CARTON (0573-0147-95)  / 2 TABLET, FILM COATED in 1 POUCH", "package_ndc": "0573-0147-95", "marketing_start_date": "20200727"}, {"sample": false, "description": "240 TABLET, FILM COATED in 1 BOTTLE (0573-0147-97)", "package_ndc": "0573-0147-97", "marketing_start_date": "20250315"}], "brand_name": "ADVIL DUAL ACTION WITH ACETAMINOPHEN", "product_id": "0573-0147_440b1444-9b6d-44c2-8ec4-dbb66ebb5025", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "0573-0147", "generic_name": "Ibuprofen, Acetaminophen", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ADVIL DUAL ACTION WITH ACETAMINOPHEN", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "250 mg/1"}, {"name": "IBUPROFEN", "strength": "125 mg/1"}], "application_number": "NDA211733", "marketing_category": "NDA", "marketing_start_date": "20200727", "listing_expiration_date": "20261231"}