Daytime Relief Severe Cold and Flu

Product NDC
55315-359
11-digit product format
553150359
Labeler code
55315
Product ID
55315-359_cb78d3dc-6775-46d5-b801-b4fc0ff8b237
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, phenylephrine hcl, dextromethorphan hbr and guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
Fred's, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-06-26
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 mg/15mL; mg/15mL; mg/15mL; mg/15mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record