advil allergy and congestion relief

Generic: chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride

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

Drug Facts

Product Profile

Brand Name advil allergy and congestion relief
Generic Name chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride
Labeler haleon us holdings llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

chlorpheniramine maleate 4 mg/1, ibuprofen 200 mg/1, phenylephrine hydrochloride 10 mg/1

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0573-0196
Product ID 0573-0196_ac233de1-41cf-4ef0-a7b4-30f395c88c1a
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA022113
Listing Expiration 2026-12-31
Marketing Start 2012-07-23

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 05730196
Hyphenated Format 0573-0196

Supplemental Identifiers

RxCUI
1310503
UNII
WK2XYI10QM 04JA59TNSJ V1Q0O9OJ9Z
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 allergy and congestion relief (source: ndc)
Generic Name chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride (source: ndc)
Application Number NDA022113 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
  • 200 mg/1
  • 10 mg/1
source: ndc
Packaging
  • 50 PACKET in 1 TRAY (0573-0196-01) / 1 TABLET, COATED in 1 PACKET
  • 2 PACKET in 1 CARTON (0573-0196-02) / 1 TABLET, COATED in 1 PACKET
  • 1 BLISTER PACK in 1 CARTON (0573-0196-10) / 10 TABLET, COATED in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (0573-0196-20) / 10 TABLET, COATED in 1 BLISTER PACK
source: ndc

Packages (4)

0573-0196-01 50 PACKET in 1 TRAY (0573-0196-01) / 1 TABLET, COATED in 1 PACKET 0573-0196-02 2 PACKET in 1 CARTON (0573-0196-02) / 1 TABLET, COATED in 1 PACKET 0573-0196-10 1 BLISTER PACK in 1 CARTON (0573-0196-10) / 10 TABLET, COATED in 1 BLISTER PACK 0573-0196-20 2 BLISTER PACK in 1 CARTON (0573-0196-20) / 10 TABLET, COATED in 1 BLISTER PACK

Ingredients (3)

chlorpheniramine maleate (4 mg/1) ibuprofen (200 mg/1) phenylephrine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Advil Allergy and Congestion Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ac233de1-41cf-4ef0-a7b4-30f395c88c1a", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM", "04JA59TNSJ", "V1Q0O9OJ9Z"], "rxcui": ["1310503"], "spl_set_id": ["a6cc97d8-252a-4527-a470-6d9e356342fd"], "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": "50 PACKET in 1 TRAY (0573-0196-01)  / 1 TABLET, COATED in 1 PACKET", "package_ndc": "0573-0196-01", "marketing_start_date": "20120723"}, {"sample": false, "description": "2 PACKET in 1 CARTON (0573-0196-02)  / 1 TABLET, COATED in 1 PACKET", "package_ndc": "0573-0196-02", "marketing_start_date": "20191001"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (0573-0196-10)  / 10 TABLET, COATED in 1 BLISTER PACK", "package_ndc": "0573-0196-10", "marketing_start_date": "20120723"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (0573-0196-20)  / 10 TABLET, COATED in 1 BLISTER PACK", "package_ndc": "0573-0196-20", "marketing_start_date": "20120723"}], "brand_name": "Advil Allergy and Congestion Relief", "product_id": "0573-0196_ac233de1-41cf-4ef0-a7b4-30f395c88c1a", "dosage_form": "TABLET, COATED", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "Nonsteroidal Anti-inflammatory Drug [EPC]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "0573-0196", "generic_name": "chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Advil Allergy and Congestion Relief", "active_ingredients": [{"name": "CHLORPHENIRAMINE MALEATE", "strength": "4 mg/1"}, {"name": "IBUPROFEN", "strength": "200 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "NDA022113", "marketing_category": "NDA", "marketing_start_date": "20120723", "listing_expiration_date": "20261231"}