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Product NDC

55316-335

11-digit product format

553160335

Labeler code

55316

Product ID

55316-335_9e6810bb-464d-456f-b899-d950aca8d6ce

Type

HUMAN OTC DRUG

Nonproprietary name

Acetaminophen, Dextromethorphan HBr, Doxylamine succinate

Dosage form

SOLUTION

Route

ORAL

Labeler

DZA Brands LLC

Application

part341

Marketing category

OTC MONOGRAPH FINAL

Marketing start

2011-09-22

Marketing end

0000-00-00

Substance

ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE

Active strength

650 mg/30mL; mg/30mL; mg/30mL

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record