dual action pain reliever

Generic: acetaminophen and ibuprofen

Labeler: bionpharma inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dual action pain reliever
Generic Name acetaminophen and ibuprofen
Labeler bionpharma inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

acetaminophen 250 mg/1, ibuprofen 125 mg/1

Manufacturer
Bionpharma Inc.

Identifiers & Regulatory

Product NDC 69452-446
Product ID 69452-446_1f470b1b-81aa-e59c-e063-6394a90a4055
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA216999
Listing Expiration 2026-12-31
Marketing Start 2024-08-09

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 69452446
Hyphenated Format 69452-446

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 dual action pain reliever (source: ndc)
Generic Name acetaminophen and ibuprofen (source: ndc)
Application Number ANDA216999 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
  • 125 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (69452-446-23) / 144 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (1)

69452-446-23 1 BOTTLE in 1 CARTON (69452-446-23) / 144 TABLET, FILM COATED in 1 BOTTLE

Ingredients (2)

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

Linked Drug Pages (1)

dual action pain reliever ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1f470b1b-81aa-e59c-e063-6394a90a4055", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["362O9ITL9D", "WK2XYI10QM"], "rxcui": ["2387532"], "spl_set_id": ["1f470b1b-81a9-e59c-e063-6394a90a4055"], "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": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (69452-446-23)  / 144 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "69452-446-23", "marketing_start_date": "20240809"}], "brand_name": "dual action pain reliever", "product_id": "69452-446_1f470b1b-81aa-e59c-e063-6394a90a4055", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "69452-446", "generic_name": "Acetaminophen and Ibuprofen", "labeler_name": "Bionpharma Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "dual action pain reliever", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "250 mg/1"}, {"name": "IBUPROFEN", "strength": "125 mg/1"}], "application_number": "ANDA216999", "marketing_category": "ANDA", "marketing_start_date": "20240809", "listing_expiration_date": "20261231"}