equate cough dm

Product NDC
49035-899
11-digit product format
490350899
Labeler code
49035
Product ID
49035-899_5c36736b-ee13-4a7e-9c9e-ae14e4c72d52
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
2015-07-21
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
49035-899-28equate cough dm148 mL in 1 BOTTLESUSPENSION1484
49035-899-28equate cough dm1 in 1 CARTONSUSPENSION14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]1
POLYVINYL ACETATEINACTIVE INGREDIENT32K497ZK2UEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]1
SODIUM POLYSTYRENE SULFONATEINACTIVE INGREDIENT1699G8679ZEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]1
SUCROSEINACTIVE INGREDIENTC151H8M554EQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]1
TRAGACANTHINACTIVE INGREDIENT2944357O2OEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]1
TRIACETININACTIVE INGREDIENTXHX3C3X673EQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]1
WATERINACTIVE INGREDIENT059QF0KO0REQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEEQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-899EQUATE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [WAL-MART STORES INC]4Current NDC, Legacy NDC, 2 package rows20200711_5f72c4ad-1c30-41ea-b39c-7f4bb3deced6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSN5f72c4ad-1c30-41ea-b39c-7f4bb3deced64
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCD5f72c4ad-1c30-41ea-b39c-7f4bb3deced64
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSY5f72c4ad-1c30-41ea-b39c-7f4bb3deced64
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSY5f72c4ad-1c30-41ea-b39c-7f4bb3deced64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-899-28490350899281 BOTTLE in 1 CARTON (49035-899-28) / 148 mL in 1 BOTTLE1 bottle2015-07-210000-00-00NoNoCurrent