Equate Cough DM

Product NDC
49035-384
11-digit product format
490350384
Labeler code
49035
Product ID
49035-384_42e472a6-ea98-46f0-95c2-539f14942b26
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan polistirex
Dosage form
SUSPENSION
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
ANDA091135
Marketing category
ANDA
Marketing start
2012-08-29
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
Equate 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
49035-384-21Equate Cough DM1 in 1 CARTONSUSPENSION16
49035-384-21Equate Cough DM89 mL in 1 BOTTLESUSPENSION896
49035-384-28Equate Cough DM148 mL in 1 BOTTLESUSPENSION1486
49035-384-28Equate Cough DM1 in 1 CARTONSUSPENSION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-384-21ML - Milliliter49035-38487291d1e-9bf4-49cf-844f-2d161975746512013-06-04
49035-384-28ML - Milliliter49035-38412af079a-b930-407b-8cc8-ab5824da81ad12019-03-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]3
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]3
POLISTIREXINACTIVE INGREDIENT5H9W9GTW27EQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]3
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]3
SODIUM POLYSTYRENE SULFONATEINACTIVE INGREDIENT1699G8679ZEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]3
SUCROSEINACTIVE INGREDIENTC151H8M554EQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]3
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]3
TRAGACANTHINACTIVE INGREDIENT2944357O2OEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]3
TRIACETININACTIVE INGREDIENTXHX3C3X673EQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]3
WATERINACTIVE INGREDIENT059QF0KO0REQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-384EQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]6Current NDC, Legacy NDC, 4 package rows20200703_956fcc21-9e0f-41e3-9304-f379364a7d1c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSN956fcc21-9e0f-41e3-9304-f379364a7d1c6
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCD956fcc21-9e0f-41e3-9304-f379364a7d1c6
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSY956fcc21-9e0f-41e3-9304-f379364a7d1c6
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSY956fcc21-9e0f-41e3-9304-f379364a7d1c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-384-21490350384211 BOTTLE in 1 CARTON (49035-384-21) / 89 mL in 1 BOTTLE1 bottle2012-08-290000-00-00NoNoCurrent
49035-384-28490350384281 BOTTLE in 1 CARTON (49035-384-28) / 148 mL in 1 BOTTLE1 bottle2013-08-200000-00-00NoNoCurrent