Night Time Severe Cold and Cough

Product NDC
55315-004
11-digit product format
553150004
Labeler code
55315
Product ID
55315-004_6cf6d7a6-d38d-44fe-9841-932c7d6c8438
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl
Dosage form
SYRUP
Route
ORAL
Labeler
Fred's, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-06-09
Marketing end
2022-08-01
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
650 mg/30mL; mg/30mL; mg/30mL
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55315-004-3355315000433245.5 mL in 1 BOTTLE (55315-004-33) 245.5 ml2016-06-092022-08-01NoNoCurrent