FDA.reportPublic FDA data

DG Health Cough DM

Product NDC
55910-384
11-digit product format
559100384
Labeler code
55910
Product ID
55910-384_d2d84599-172b-453b-b96c-163f8d4ce831
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan polistirex
Dosage form
SUSPENSION
Route
ORAL
Labeler
Dolgencorp Inc
Application
ANDA091135
Marketing category
ANDA
Marketing start
2013-07-02
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DG Health Cough DM
Listing expiration
2027-12-31

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
55910-384-21DG Health Cough DM89 mL in 1 BOTTLESUSPENSION896
55910-384-21DG Health Cough DM1 in 1 CARTONSUSPENSION16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHDG HEALTH COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [DOLGENCORP, LLC]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSDG HEALTH COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [DOLGENCORP, LLC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDG HEALTH COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [DOLGENCORP, LLC]2
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SDG HEALTH COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [DOLGENCORP, LLC]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDG HEALTH COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [DOLGENCORP, LLC]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDG HEALTH COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [DOLGENCORP, LLC]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EDG HEALTH COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [DOLGENCORP, LLC]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHDG HEALTH COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [DOLGENCORP, LLC]2
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CDG HEALTH COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [DOLGENCORP, LLC]2
SODIUM POLYSTYRENE SULFONATEINACTIVE INGREDIENT1699G8679ZDG HEALTH COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [DOLGENCORP, LLC]2
SUCROSEINACTIVE INGREDIENTC151H8M554DG HEALTH COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [DOLGENCORP, LLC]2
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HDG HEALTH COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [DOLGENCORP, LLC]2
TRAGACANTHINACTIVE INGREDIENT2944357O2ODG HEALTH COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [DOLGENCORP, LLC]2
TRIACETININACTIVE INGREDIENTXHX3C3X673DG HEALTH COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [DOLGENCORP, LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RDG HEALTH COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [DOLGENCORP, LLC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEDG HEALTH COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [DOLGENCORP, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-384DG HEALTH COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [DOLGENCORP, LLC]5Current NDC, Legacy NDC, 2 package rows20200702_648ca6b2-d31f-4941-baad-0f2accd30a9e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSN648ca6b2-d31f-4941-baad-0f2accd30a9e6
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCD648ca6b2-d31f-4941-baad-0f2accd30a9e6
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSY648ca6b2-d31f-4941-baad-0f2accd30a9e6
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSY648ca6b2-d31f-4941-baad-0f2accd30a9e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-384-21559100384211 BOTTLE in 1 CARTON (55910-384-21) / 89 mL in 1 BOTTLE1 bottle2013-07-020000-00-00NoNoCurrent