NIGHTTIME SEVERE COLD AND FLU

Product NDC

51316-477

11-digit product format

513160477

Labeler code

51316

Product ID

51316-477_7deea588-0213-4592-b56f-6db418bf8ff2

Type

HUMAN OTC DRUG

Nonproprietary name

Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl

Dosage form

SOLUTION

Route

ORAL

Labeler

CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Application

M012

Marketing category

OTC MONOGRAPH DRUG

Marketing start

2026-07-14

Substance

ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE

Active strength

650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL

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

2027-12-31

Current FDA listing

Yes