CareOne Cough DM

Product NDC
41520-384
11-digit product format
415200384
Labeler code
41520
Product ID
41520-384_ee23d1e6-bf24-4943-8d82-305b05a691e5
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan polistirex
Dosage form
SUSPENSION
Route
ORAL
Labeler
American Sales Company
Application
ANDA091135
Marketing category
ANDA
Marketing start
2012-08-30
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
CareOne 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
41520-384-21CareOne Cough DM89 mL in 1 BOTTLESUSPENSION895
41520-384-21CareOne Cough DM1 in 1 CARTONSUSPENSION15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCAREONE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [AMERICAN SALES COMPANY]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCAREONE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [AMERICAN SALES COMPANY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCAREONE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [AMERICAN SALES COMPANY]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SCAREONE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [AMERICAN SALES COMPANY]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCAREONE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [AMERICAN SALES COMPANY]1
POLISTIREXINACTIVE INGREDIENT5H9W9GTW27CAREONE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [AMERICAN SALES COMPANY]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCAREONE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [AMERICAN SALES COMPANY]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ECAREONE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [AMERICAN SALES COMPANY]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCAREONE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [AMERICAN SALES COMPANY]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CCAREONE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [AMERICAN SALES COMPANY]1
SODIUM POLYSTYRENE SULFONATEINACTIVE INGREDIENT1699G8679ZCAREONE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [AMERICAN SALES COMPANY]1
SUCROSEINACTIVE INGREDIENTC151H8M554CAREONE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [AMERICAN SALES COMPANY]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HCAREONE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [AMERICAN SALES COMPANY]1
TRAGACANTHINACTIVE INGREDIENT2944357O2OCAREONE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [AMERICAN SALES COMPANY]1
TRIACETININACTIVE INGREDIENTXHX3C3X673CAREONE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [AMERICAN SALES COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RCAREONE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [AMERICAN SALES COMPANY]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECAREONE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [AMERICAN SALES COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-384CAREONE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [AMERICAN SALES COMPANY]5Current NDC, Legacy NDC, 2 package rows20200703_2543912b-e6dd-46ca-8f0e-12603f6c28a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSN2543912b-e6dd-46ca-8f0e-12603f6c28a75
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCD2543912b-e6dd-46ca-8f0e-12603f6c28a75
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSY2543912b-e6dd-46ca-8f0e-12603f6c28a75
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSY2543912b-e6dd-46ca-8f0e-12603f6c28a75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-384-21415200384211 BOTTLE in 1 CARTON (41520-384-21) / 89 mL in 1 BOTTLE1 bottle2012-08-300000-00-00NoNoCurrent