advil sinus congestion and pain

Generic: ibuprofen, phenylephrine hydrochloride

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

Drug Facts

Product Profile

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

ibuprofen 200 mg/1, phenylephrine hydrochloride 10 mg/1

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0573-0199
Product ID 0573-0199_3a894971-32f7-0c16-e063-6294a90aa8d9
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA022565
Listing Expiration 2026-12-31
Marketing Start 2015-07-01

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 05730199
Hyphenated Format 0573-0199

Supplemental Identifiers

RxCUI
1369775
UNII
WK2XYI10QM 04JA59TNSJ
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 sinus congestion and pain (source: ndc)
Generic Name ibuprofen, phenylephrine hydrochloride (source: ndc)
Application Number NDA022565 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
  • 10 mg/1
source: ndc
Packaging
  • 50 POUCH in 1 TRAY (0573-0199-01) / 1 TABLET, COATED in 1 POUCH
  • 3000 POUCH in 1 CARTON (0573-0199-03) / 1 TABLET, COATED in 1 POUCH
  • 10 BLISTER PACK in 1 CARTON (0573-0199-11) / 1 TABLET, COATED in 1 BLISTER PACK
  • 20 BLISTER PACK in 1 CARTON (0573-0199-21) / 1 TABLET, COATED in 1 BLISTER PACK
  • 30 BLISTER PACK in 1 CARTON (0573-0199-22) / 1 TABLET, COATED in 1 BLISTER PACK
source: ndc

Packages (5)

0573-0199-01 50 POUCH in 1 TRAY (0573-0199-01) / 1 TABLET, COATED in 1 POUCH 0573-0199-03 3000 POUCH in 1 CARTON (0573-0199-03) / 1 TABLET, COATED in 1 POUCH 0573-0199-11 10 BLISTER PACK in 1 CARTON (0573-0199-11) / 1 TABLET, COATED in 1 BLISTER PACK 0573-0199-21 20 BLISTER PACK in 1 CARTON (0573-0199-21) / 1 TABLET, COATED in 1 BLISTER PACK 0573-0199-22 30 BLISTER PACK in 1 CARTON (0573-0199-22) / 1 TABLET, COATED in 1 BLISTER PACK

Ingredients (2)

ibuprofen (200 mg/1) phenylephrine hydrochloride (10 mg/1)

Linked Drug Pages (1)

ADVIL SINUS CONGESTION AND PAIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3a894971-32f7-0c16-e063-6294a90aa8d9", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM", "04JA59TNSJ"], "rxcui": ["1369775"], "spl_set_id": ["b1e29c19-fe03-4d2b-b966-0adf4eb4b4cf"], "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 POUCH in 1 TRAY (0573-0199-01)  / 1 TABLET, COATED in 1 POUCH", "package_ndc": "0573-0199-01", "marketing_start_date": "20150701"}, {"sample": false, "description": "3000 POUCH in 1 CARTON (0573-0199-03)  / 1 TABLET, COATED in 1 POUCH", "package_ndc": "0573-0199-03", "marketing_start_date": "20150701"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (0573-0199-11)  / 1 TABLET, COATED in 1 BLISTER PACK", "package_ndc": "0573-0199-11", "marketing_start_date": "20150701"}, {"sample": false, "description": "20 BLISTER PACK in 1 CARTON (0573-0199-21)  / 1 TABLET, COATED in 1 BLISTER PACK", "package_ndc": "0573-0199-21", "marketing_start_date": "20150701"}, {"sample": false, "description": "30 BLISTER PACK in 1 CARTON (0573-0199-22)  / 1 TABLET, COATED in 1 BLISTER PACK", "package_ndc": "0573-0199-22", "marketing_start_date": "20151102"}], "brand_name": "ADVIL SINUS CONGESTION AND PAIN", "product_id": "0573-0199_3a894971-32f7-0c16-e063-6294a90aa8d9", "dosage_form": "TABLET, COATED", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "0573-0199", "generic_name": "ibuprofen, phenylephrine hydrochloride", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ADVIL SINUS CONGESTION AND PAIN", "active_ingredients": [{"name": "IBUPROFEN", "strength": "200 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "NDA022565", "marketing_category": "NDA", "marketing_start_date": "20150701", "listing_expiration_date": "20261231"}