TopCare Cough DM

Product NDC
36800-899
11-digit product format
368000899
Labeler code
36800
Product ID
36800-899_dde54df7-f8ab-437d-bb92-9e274723893f
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan polistirex
Dosage form
SUSPENSION
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA091135
Marketing category
ANDA
Marketing start
2015-07-30
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE
Active strength
30 mg/5mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHTOPCARE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [TOPCO ASSOCIATES LLC]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSTOPCARE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [TOPCO ASSOCIATES LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTOPCARE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [TOPCO ASSOCIATES LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTOPCARE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [TOPCO ASSOCIATES LLC]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6STOPCARE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [TOPCO ASSOCIATES LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TTOPCARE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [TOPCO ASSOCIATES LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTOPCARE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [TOPCO ASSOCIATES LLC]1
POLYVINYL ACETATEINACTIVE INGREDIENT32K497ZK2UTOPCARE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [TOPCO ASSOCIATES LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ETOPCARE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [TOPCO ASSOCIATES LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHTOPCARE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [TOPCO ASSOCIATES LLC]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CTOPCARE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [TOPCO ASSOCIATES LLC]1
SODIUM POLYSTYRENE SULFONATEINACTIVE INGREDIENT1699G8679ZTOPCARE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [TOPCO ASSOCIATES LLC]1
SUCROSEINACTIVE INGREDIENTC151H8M554TOPCARE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [TOPCO ASSOCIATES LLC]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HTOPCARE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [TOPCO ASSOCIATES LLC]1
TRAGACANTHINACTIVE INGREDIENT2944357O2OTOPCARE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [TOPCO ASSOCIATES LLC]1
TRIACETININACTIVE INGREDIENTXHX3C3X673TOPCARE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [TOPCO ASSOCIATES LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RTOPCARE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [TOPCO ASSOCIATES LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEETOPCARE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [TOPCO ASSOCIATES LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-899TOPCARE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [TOPCO ASSOCIATES LLC]4Legacy NDC20200711_65a01786-974b-42ab-964e-4017e72c3095.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-899-21368000899211 BOTTLE in 1 CARTON (36800-899-21) > 89 mL in 1 BOTTLE1 bottle2015-07-300000-00-00NoNoCurrent