Cold Preparation

Product NDC

11868-311

11-digit product format

118680311

Labeler code

11868

Product ID

11868-311_4cf509b4-c1e2-4e71-ab1f-3009ca4be3d8

Type

HUMAN OTC DRUG

Nonproprietary name

Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride

Dosage form

LIQUID

Route

ORAL

Labeler

New Genesis/Monticello Drug LLC

Application

part341

Marketing category

OTC MONOGRAPH FINAL

Marketing start

2014-08-31

Marketing end

2020-01-01

Substance

ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE

Active strength

325 mg/15mL; mg/15mL; mg/15mL

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record