FDA.reportPublic FDA data

Sound Body Tussin DM

Product NDC
50594-021
11-digit product format
505940021
Labeler code
50594
Product ID
50594-021_56288bfc-6908-416f-9c3d-763e539c7da6
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
Big Lots Stores, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-09-19
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20 mg/10mL; mg/10mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50594-021DDiscontinued by firm2026-08-03
excluded packagepackage50594-02150594-021-26DDiscontinued by firm2026-08-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50594-021-26505940021261 BOTTLE in 1 CARTON (50594-021-26) > 118 mL in 1 BOTTLE1 bottle2016-09-190000-00-00NoNoCurrent