FDA.reportPublic FDA data

good sense cough dm

Product NDC
0113-0384
11-digit product format
001130384
Labeler code
0113
Product ID
0113-0384_5b3da5de-abd3-4bb7-8649-3d6e7d020308
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan polistirex
Dosage form
SUSPENSION
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA091135
Marketing category
ANDA
Marketing start
2013-02-01
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
good sense 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
0113-0384-21good sense cough dm1 in 1 CARTONSUSPENSION18
0113-0384-21good sense cough dm89 mL in 1 BOTTLESUSPENSION898
0113-0384-28good sense cough dm1 in 1 CARTONSUSPENSION18
0113-0384-28good sense cough dm148 mL in 1 BOTTLESUSPENSION1488

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0384GOOD SENSE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [L. PERRIGO COMPANY]7Current NDC, Legacy NDC, 4 package rows20240229_1b11b25b-2716-45f9-830f-ddf622366e60.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSN1b11b25b-2716-45f9-830f-ddf622366e608
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCD1b11b25b-2716-45f9-830f-ddf622366e608
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSY1b11b25b-2716-45f9-830f-ddf622366e608
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSY1b11b25b-2716-45f9-830f-ddf622366e608

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0384-21001130384211 BOTTLE in 1 CARTON (0113-0384-21) > 89 mL in 1 BOTTLE1 bottle2013-02-010000-00-00NoNoCurrent
0113-0384-28001130384281 BOTTLE in 1 CARTON (0113-0384-28) / 148 mL in 1 BOTTLE1 bottle2013-07-250000-00-00NoNoCurrent