FDA.reportPublic FDA data

cough dm

Product NDC
30142-494
11-digit product format
301420494
Labeler code
30142
Product ID
30142-494_edcbf3b1-819e-4873-b954-c6af366a5a06
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan polistirex
Dosage form
SUSPENSION, EXTENDED RELEASE
Route
ORAL
Labeler
Kroger Company
Application
ANDA091135
Marketing category
ANDA
Marketing start
2018-06-28
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
30142-494-21cough dm89 mL in 1 BOTTLESUSPENSION, EXTENDED RELEASE894
30142-494-21cough dm1 in 1 CARTONSUSPENSION, EXTENDED RELEASE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-494COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [KROGER COMPANY]4Current NDC, Legacy NDC, 2 package rows20200910_d98aa017-88db-4fe6-a260-ad6f3d8e23ea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSNd98aa017-88db-4fe6-a260-ad6f3d8e23ea4
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCDd98aa017-88db-4fe6-a260-ad6f3d8e23ea4
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSYd98aa017-88db-4fe6-a260-ad6f3d8e23ea4
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSYd98aa017-88db-4fe6-a260-ad6f3d8e23ea4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-494-21301420494211 BOTTLE in 1 CARTON (30142-494-21) / 89 mL in 1 BOTTLE1 bottle2018-06-280000-00-00NoNoCurrent