ADVIL COLD AND SINUS

Product NDC
0573-2160
11-digit product format
005732160
Labeler code
0573
Product ID
0573-2160_cec76100-19bc-49c3-8805-7badb2a8bf28
Type
HUMAN OTC DRUG
Nonproprietary name
ibuprofen and pseudoephedrine hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
NDA019771
Marketing category
NDA
Marketing start
2018-01-01
Substance
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
200; 30 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
WK2XYI10QMIBUPROFEN15687-27-1IBUPROFEN
6V9V2RYJ8NPSEUDOEPHEDRINE HYDROCHLORIDE345-78-8PSEUDOEPHEDRINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0573-2160-74005732160742 CARTON in 1 PACKAGE (0573-2160-74) / 4 BLISTER PACK in 1 CARTON / 10 TABLET, COATED in 1 BLISTER PACK2 carton2018-01-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Drug FactsHaleon US Holdings LLC2025-06-13HUMAN OTC DRUG LABEL16