Cough DM

Product NDC
0363-0384
11-digit product format
003630384
Labeler code
0363
Product ID
0363-0384_4d041b9d-4324-41d7-a5c7-c46d90af4157
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan polistirex
Dosage form
SUSPENSION
Route
ORAL
Labeler
Walgreen Company
Application
ANDA091135
Marketing category
ANDA
Marketing start
2012-08-28
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
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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
a90f088a-9578-47a2-8f6e-0a9d32aafec6Product name120181030
f6c90bdc-1674-455a-aadd-1b1b59e5edebProduct name220181030
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0384-21Cough DM89 mL in 1 BOTTLESUSPENSION897
0363-0384-21Cough DM1 in 1 CARTONSUSPENSION17
0363-0384-28Cough DM1 in 1 CARTONSUSPENSION17
0363-0384-28Cough DM148 mL in 1 BOTTLESUSPENSION1487

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0384-21ML - Milliliter0363-0384ecb7be4e-0e18-4a6c-8cac-c369b9c011b312014-02-04
0363-0384-28ML - Milliliter0363-0384175b4cc9-cacf-4fd4-a1eb-2d8aa46c8d7812015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WALGREEN COMPANY]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WALGREEN COMPANY]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WALGREEN COMPANY]2
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WALGREEN COMPANY]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WALGREEN COMPANY]2
POLISTIREXINACTIVE INGREDIENT5H9W9GTW27COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WALGREEN COMPANY]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WALGREEN COMPANY]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ECOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WALGREEN COMPANY]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WALGREEN COMPANY]2
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WALGREEN COMPANY]2
SODIUM POLYSTYRENE SULFONATEINACTIVE INGREDIENT1699G8679ZCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WALGREEN COMPANY]2
SUCROSEINACTIVE INGREDIENTC151H8M554COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WALGREEN COMPANY]2
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WALGREEN COMPANY]2
TRAGACANTHINACTIVE INGREDIENT2944357O2OCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WALGREEN COMPANY]2
TRIACETININACTIVE INGREDIENTXHX3C3X673COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WALGREEN COMPANY]2
WATERINACTIVE INGREDIENT059QF0KO0RCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WALGREEN COMPANY]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WALGREEN COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0384COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WALGREEN COMPANY]7Current NDC, Legacy NDC, 4 package rows20230523_c628923a-6771-4aba-9e2d-4795c9effb33.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSNc628923a-6771-4aba-9e2d-4795c9effb337
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCDc628923a-6771-4aba-9e2d-4795c9effb337
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSYc628923a-6771-4aba-9e2d-4795c9effb337
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSYc628923a-6771-4aba-9e2d-4795c9effb337

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0384-21003630384211 BOTTLE in 1 CARTON (0363-0384-21) / 89 mL in 1 BOTTLE1 bottle2012-08-280000-00-00NoNoCurrent
0363-0384-28003630384281 BOTTLE in 1 CARTON (0363-0384-28) / 148 mL in 1 BOTTLE1 bottle2013-07-160000-00-00NoNoCurrent