FDA.reportPublic FDA data

TopCare Cough DM

Product NDC
36800-494
11-digit product format
368000494
Labeler code
36800
Product ID
36800-494_2dabf072-f553-4228-8990-58af55f66b32
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan polistirex
Dosage form
SUSPENSION, EXTENDED RELEASE
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA091135
Marketing category
ANDA
Marketing start
2015-07-30
Substance
DEXTROMETHORPHAN HYDROBROMIDE
Active strength
30 mg/5mL
Pharmacologic classes
Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TopCare Cough DM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH
Rxcui1373045

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
a90f088a-9578-47a2-8f6e-0a9d32aafec6Product name120181030
f6c90bdc-1674-455a-aadd-1b1b59e5edebProduct name220181030
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-494-21TopCare Cough DM1 in 1 CARTONSUSPENSION, EXTENDED RELEASE18
36800-494-21TopCare Cough DM89 mL in 1 BOTTLESUSPENSION, EXTENDED RELEASE898
36800-494-28TopCare Cough DM1 in 1 CARTONSUSPENSION, EXTENDED RELEASE18
36800-494-28TopCare Cough DM148 mL in 1 BOTTLESUSPENSION, EXTENDED RELEASE1488

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-494TOPCARE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [TOPCO ASSOCIATES LLC]7Current NDC, Legacy NDC, 4 package rows20240815_490f695c-e60f-43db-b3f3-a9ffbb2906dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSN490f695c-e60f-43db-b3f3-a9ffbb2906dd8
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCD490f695c-e60f-43db-b3f3-a9ffbb2906dd8
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSY490f695c-e60f-43db-b3f3-a9ffbb2906dd8
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSY490f695c-e60f-43db-b3f3-a9ffbb2906dd8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-494-21368000494211 BOTTLE in 1 CARTON (36800-494-21) / 89 mL in 1 BOTTLE1 bottle2015-07-300000-00-00NoNoCurrent
36800-494-28368000494281 BOTTLE in 1 CARTON (36800-494-28) / 148 mL in 1 BOTTLE1 bottle2024-08-08NoNoCurrent