FDA.reportPublic FDA data

Cough DM

Product NDC
0363-0494
11-digit product format
003630494
Labeler code
0363
Product ID
0363-0494_f3141d25-e1d7-4e53-a5f7-87145a9a8c82
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan polistirex
Dosage form
SUSPENSION, EXTENDED RELEASE
Route
ORAL
Labeler
Walgreen Company
Application
ANDA091135
Marketing category
ANDA
Marketing start
2015-07-01
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
0363-0494-21Cough DM89 mL in 1 BOTTLESUSPENSION, EXTENDED RELEASE897
0363-0494-21Cough DM1 in 1 CARTONSUSPENSION, EXTENDED RELEASE17
0363-0494-28Cough DM1 in 1 CARTONSUSPENSION, EXTENDED RELEASE17
0363-0494-28Cough DM148 mL in 1 BOTTLESUSPENSION, EXTENDED RELEASE1487

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0494-21ML - Milliliter0363-04941974365c-8380-479d-8860-2aa3a4f38a4612015-10-02
0363-0494-28ML - Milliliter0363-04948929bd42-4711-47bc-afe7-1b98ecb9775a12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [WALGREEN COMPANY]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [WALGREEN COMPANY]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [WALGREEN COMPANY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [WALGREEN COMPANY]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [WALGREEN COMPANY]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [WALGREEN COMPANY]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [WALGREEN COMPANY]1
POLYVINYL ACETATEINACTIVE INGREDIENT32K497ZK2UCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [WALGREEN COMPANY]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ECOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [WALGREEN COMPANY]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [WALGREEN COMPANY]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [WALGREEN COMPANY]1
SODIUM POLYSTYRENE SULFONATEINACTIVE INGREDIENT1699G8679ZCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [WALGREEN COMPANY]1
SUCROSEINACTIVE INGREDIENTC151H8M554COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [WALGREEN COMPANY]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [WALGREEN COMPANY]1
TRAGACANTHINACTIVE INGREDIENT2944357O2OCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [WALGREEN COMPANY]1
TRIACETININACTIVE INGREDIENTXHX3C3X673COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [WALGREEN COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RCOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [WALGREEN COMPANY]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECOUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [WALGREEN COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0494COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [WALGREEN COMPANY]7Current NDC, Legacy NDC, 4 package rows20230617_be67fb34-6ecb-4b45-9a67-3f78f4af8e36.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSNbe67fb34-6ecb-4b45-9a67-3f78f4af8e367
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCDbe67fb34-6ecb-4b45-9a67-3f78f4af8e367
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSYbe67fb34-6ecb-4b45-9a67-3f78f4af8e367
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSYbe67fb34-6ecb-4b45-9a67-3f78f4af8e367

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0494-21003630494211 BOTTLE in 1 CARTON (0363-0494-21) > 89 mL in 1 BOTTLE1 bottle2015-07-010000-00-00NoNoCurrent
0363-0494-28003630494281 BOTTLE in 1 CARTON (0363-0494-28) / 148 mL in 1 BOTTLE1 bottle2017-05-200000-00-00NoNoCurrent