Day Time Cold and Flu

Product NDC
53441-311
11-digit product format
534410311
Labeler code
53441
Product ID
53441-311_bb3ee1ad-0da9-41b3-8385-bc0cf1b9d711
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
National Distribution Network (Smart Choice)
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-06-30
Marketing end
2021-12-30
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53441-311-0653441031106177 mL in 1 BOTTLE (53441-311-06) 177 ml2014-06-302021-12-30NoNoCurrent
53441-311-0853441031108237 mL in 1 BOTTLE (53441-311-08) 237 ml2014-06-302021-12-30NoNoCurrent