QUALITY CHOICE Maximum Strength Nighttime Cold and Flu

Product NDC
83324-224
11-digit product format
833240224
Labeler code
83324
Product ID
83324-224_e81cf587-fa09-4d01-8d63-ae8094cd7a0a
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Chain Drug Marketing Association, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-04
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 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
362O9ITL9DACETAMINOPHEN103-90-2ACETAMINOPHEN
9D2RTI9KYHDEXTROMETHORPHAN HYDROBROMIDE6700-34-1DEXTROMETHORPHAN HYDROBROMIDE
V9BI9B5YI2DOXYLAMINE SUCCINATE562-10-7DOXYLAMINE SUCCINATE
04JA59TNSJPHENYLEPHRINE HYDROCHLORIDE61-76-7PHENYLEPHRINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83324-224-24833240224242 BLISTER PACK in 1 CARTON (83324-224-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2025-11-04NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
QUALITY CHOICE ® Maximum Strength Nighttime Cold & Flu SoftgelsChain Drug Marketing Association, Inc.2025-11-04HUMAN OTC DRUG LABEL2