Pediatric Cough and Cold Medicine

Product NDC
54838-115
11-digit product format
548380115
Labeler code
54838
Product ID
54838-115_2e6126c9-4fb1-4cd7-b5e3-449123620bbc
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorpheniramine maleate and Pseudoephedrine hydrochloride and Dextromethorphan hydrobromide
Dosage form
LIQUID
Route
ORAL
Labeler
Lannett Company, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1997-01-05
Marketing end
0000-00-00
Substance
CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
1 mg/5mL; mg/5mL; mg/5mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54838-115-40ML - Milliliter54838-1151152ae5a-56ee-4cee-a697-5da6ac3c4e9d12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54838-115-4054838011540120 mL in 1 BOTTLE, PLASTIC (54838-115-40) 120 ml1997-01-050000-00-00NoNoCurrent