advil cold and sinus

Generic: ibuprofen, 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, pseudoephedrine hydrochloride
Labeler haleon us holdings llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

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

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0573-0184
Product ID 0573-0184_3e883935-a6b2-f5fc-e063-6294a90a7789
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA021374
Listing Expiration 2026-12-31
Marketing Start 2002-05-30

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 05730184
Hyphenated Format 0573-0184

Supplemental Identifiers

RxCUI
1299018
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, pseudoephedrine hydrochloride (source: ndc)
Application Number NDA021374 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
  • 30 mg/1
source: ndc
Packaging
  • 16 BLISTER PACK in 1 CARTON (0573-0184-16) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
  • 32 BLISTER PACK in 1 CARTON (0573-0184-32) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (2)

Ingredients (2)

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

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "3e883935-a6b2-f5fc-e063-6294a90a7789", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM", "6V9V2RYJ8N"], "rxcui": ["1299018"], "spl_set_id": ["0da9ed22-bfb4-d61b-110b-0c7760332a98"], "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": "16 BLISTER PACK in 1 CARTON (0573-0184-16)  / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "0573-0184-16", "marketing_start_date": "20020530"}, {"sample": false, "description": "32 BLISTER PACK in 1 CARTON (0573-0184-32)  / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "0573-0184-32", "marketing_start_date": "20020530"}], "brand_name": "ADVIL COLD AND SINUS", "product_id": "0573-0184_3e883935-a6b2-f5fc-e063-6294a90a7789", "dosage_form": "CAPSULE, LIQUID FILLED", "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": "0573-0184", "generic_name": "ibuprofen, 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": "NDA021374", "marketing_category": "NDA", "marketing_start_date": "20020530", "listing_expiration_date": "20261231"}