DayTime Cold and Flu

Product NDC

53345-004

11-digit product format

533450004

Labeler code

53345

Product ID

53345-004_2752d028-7e6a-bcdc-e063-6394a90a26eb

Type

HUMAN OTC DRUG

Nonproprietary name

acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride

Dosage form

CAPSULE, LIQUID FILLED

Route

ORAL

Labeler

Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.

Application

M012

Marketing category

OTC MONOGRAPH DRUG

Marketing start

2013-06-15

Substance

ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE

Active strength

325; 10; 5 mg/1; mg/1; mg/1

Pharmacologic classes

Adrenergic alpha1-Agonists [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