Cold Preparation

Product NDC
11868-466
11-digit product format
118680466
Labeler code
11868
Product ID
11868-466_58cc3e36-c26c-49ed-b0bc-344ca2926ac4
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
New Genesis/Monticello Drug LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-06-30
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
11868-466-0811868046608236 mL in 1 BOTTLE, PLASTIC (11868-466-08) 236 ml2015-06-302021-12-30NoNoCurrent
11868-466-1211868046612355 mL in 1 BOTTLE, PLASTIC (11868-466-12) 355 ml2015-06-302021-12-30NoNoCurrent