advil cold and sinus

Generic: ibuprofen and pseudoephedrine hydrochloride

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

Drug Facts

Product Profile

Brand Name advil cold and sinus
Generic Name ibuprofen and pseudoephedrine hydrochloride
Labeler haleon us holdings llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

ibuprofen 200 mg/1, pseudoephedrine hydrochloride 30 mg/1

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0573-2160
Product ID 0573-2160_cec76100-19bc-49c3-8805-7badb2a8bf28
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA019771
Listing Expiration 2026-12-31
Marketing Start 2018-01-01

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 05732160
Hyphenated Format 0573-2160

Supplemental Identifiers

RxCUI
1299021
UNII
WK2XYI10QM 6V9V2RYJ8N
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 cold and sinus (source: ndc)
Generic Name ibuprofen and pseudoephedrine hydrochloride (source: ndc)
Application Number NDA019771 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
  • 30 mg/1
source: ndc
Packaging
  • 2 CARTON in 1 PACKAGE (0573-2160-74) / 4 BLISTER PACK in 1 CARTON / 10 TABLET, COATED in 1 BLISTER PACK
source: ndc

Packages (1)

0573-2160-74 2 CARTON in 1 PACKAGE (0573-2160-74) / 4 BLISTER PACK in 1 CARTON / 10 TABLET, COATED in 1 BLISTER PACK

Ingredients (2)

ibuprofen (200 mg/1) pseudoephedrine hydrochloride (30 mg/1)

Linked Drug Pages (1)

ADVIL COLD AND SINUS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "cec76100-19bc-49c3-8805-7badb2a8bf28", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM", "6V9V2RYJ8N"], "rxcui": ["1299021"], "spl_set_id": ["fac22a47-f0de-4505-fd8a-768430cda0c1"], "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 CARTON in 1 PACKAGE (0573-2160-74)  / 4 BLISTER PACK in 1 CARTON / 10 TABLET, COATED in 1 BLISTER PACK", "package_ndc": "0573-2160-74", "marketing_start_date": "20180101"}], "brand_name": "ADVIL COLD AND SINUS", "product_id": "0573-2160_cec76100-19bc-49c3-8805-7badb2a8bf28", "dosage_form": "TABLET, COATED", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "0573-2160", "generic_name": "ibuprofen and pseudoephedrine hydrochloride", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ADVIL COLD AND SINUS", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "NDA019771", "marketing_category": "NDA", "marketing_start_date": "20180101", "listing_expiration_date": "20261231"}