advil dual action with acetaminophen back pain

Generic: ibuprofen, acetaminophen

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

Drug Facts

Product Profile

Brand Name advil dual action with acetaminophen back pain
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 0573-0145
Product ID 0573-0145_9c2623fc-aba0-4ae6-bb1e-e1e52f47b09c
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA211733
Listing Expiration 2026-12-31
Marketing Start 2023-01-16

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 05730145
Hyphenated Format 0573-0145

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 back pain (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
  • 2 TABLET, FILM COATED in 1 POUCH (0573-0145-02)
  • 1 BOTTLE in 1 CARTON (0573-0145-18) / 18 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0573-0145-72) / 72 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0573-0145-89) / 144 TABLET, FILM COATED in 1 BOTTLE
  • 3000 POUCH in 1 CASE (0573-0145-99) / 2 TABLET, FILM COATED in 1 POUCH
source: ndc

Packages (5)

0573-0145-02 2 TABLET, FILM COATED in 1 POUCH (0573-0145-02) 0573-0145-18 1 BOTTLE in 1 CARTON (0573-0145-18) / 18 TABLET, FILM COATED in 1 BOTTLE 0573-0145-72 1 BOTTLE in 1 CARTON (0573-0145-72) / 72 TABLET, FILM COATED in 1 BOTTLE 0573-0145-89 1 BOTTLE in 1 CARTON (0573-0145-89) / 144 TABLET, FILM COATED in 1 BOTTLE 0573-0145-99 3000 POUCH in 1 CASE (0573-0145-99) / 2 TABLET, FILM COATED in 1 POUCH

Ingredients (2)

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

Linked Drug Pages (1)

ADVIL DUAL ACTION WITH ACETAMINOPHEN Back Pain ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9c2623fc-aba0-4ae6-bb1e-e1e52f47b09c", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["362O9ITL9D", "WK2XYI10QM"], "rxcui": ["2387532"], "spl_set_id": ["acaa9806-e552-44f2-a680-b8bb64c49e1f"], "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": "2 TABLET, FILM COATED in 1 POUCH (0573-0145-02)", "package_ndc": "0573-0145-02", "marketing_start_date": "20230116"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0573-0145-18)  / 18 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0573-0145-18", "marketing_start_date": "20230116"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0573-0145-72)  / 72 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0573-0145-72", "marketing_start_date": "20230116"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0573-0145-89)  / 144 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0573-0145-89", "marketing_start_date": "20230116"}, {"sample": false, "description": "3000 POUCH in 1 CASE (0573-0145-99)  / 2 TABLET, FILM COATED in 1 POUCH", "package_ndc": "0573-0145-99", "marketing_start_date": "20230116"}], "brand_name": "ADVIL DUAL ACTION WITH ACETAMINOPHEN Back Pain", "product_id": "0573-0145_9c2623fc-aba0-4ae6-bb1e-e1e52f47b09c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "0573-0145", "generic_name": "Ibuprofen, Acetaminophen", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ADVIL DUAL ACTION WITH ACETAMINOPHEN", "brand_name_suffix": "Back Pain", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "250 mg/1"}, {"name": "IBUPROFEN", "strength": "125 mg/1"}], "application_number": "NDA211733", "marketing_category": "NDA", "marketing_start_date": "20230116", "listing_expiration_date": "20261231"}