Healthy Accents Mucus Relief DM

Product NDC
55316-735
11-digit product format
553160735
Labeler code
55316
Product ID
55316-735_a8d4c975-fd97-4f13-8a13-82a1db73b405
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
DZA Brands LLC
Application
ANDA091070
Marketing category
ANDA
Marketing start
2016-08-11
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
60 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record