FDA.reportPublic FDA data

Good Sense Cough DM

Product NDC
0113-0958
11-digit product format
001130958
Labeler code
0113
Product ID
0113-0958_79797a69-3564-46c2-b358-3aba1f986334
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan polistirex
Dosage form
SUSPENSION
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA091135
Marketing category
ANDA
Marketing start
2013-06-20
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
0113-0958-21Good Sense Cough DM89 mL in 1 BOTTLESUSPENSION894
0113-0958-21Good Sense Cough DM1 in 1 CARTONSUSPENSION14
0113-0958-28Good Sense Cough DM1 in 1 CARTONSUSPENSION14
0113-0958-28Good Sense Cough DM148 mL in 1 BOTTLESUSPENSION1484

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0958-21ML - Milliliter0113-09583ae8c6e9-c1a1-41cf-96e2-2a81136361a812018-02-20
0113-0958-28ML - Milliliter0113-09586e0711de-295c-4a1c-83c8-3d3b61e9f8cd12018-02-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHGOOD SENSE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [L. PERRIGO COMPANY]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSGOOD SENSE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [L. PERRIGO COMPANY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXGOOD SENSE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [L. PERRIGO COMPANY]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SGOOD SENSE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [L. PERRIGO COMPANY]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGOOD SENSE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [L. PERRIGO COMPANY]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGOOD SENSE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [L. PERRIGO COMPANY]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EGOOD SENSE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [L. PERRIGO COMPANY]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHGOOD SENSE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [L. PERRIGO COMPANY]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CGOOD SENSE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [L. PERRIGO COMPANY]1
SODIUM POLYSTYRENE SULFONATEINACTIVE INGREDIENT1699G8679ZGOOD SENSE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [L. PERRIGO COMPANY]1
SUCROSEINACTIVE INGREDIENTC151H8M554GOOD SENSE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [L. PERRIGO COMPANY]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HGOOD SENSE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [L. PERRIGO COMPANY]1
TRAGACANTHINACTIVE INGREDIENT2944357O2OGOOD SENSE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [L. PERRIGO COMPANY]1
TRIACETININACTIVE INGREDIENTXHX3C3X673GOOD SENSE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [L. PERRIGO COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RGOOD SENSE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [L. PERRIGO COMPANY]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEGOOD SENSE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [L. PERRIGO COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0958GOOD SENSE COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [L. PERRIGO COMPANY]4Current NDC, Legacy NDC, 4 package rows20200723_5a2e9bef-42cb-4b72-9a26-c3ae71dcb4ea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSN5a2e9bef-42cb-4b72-9a26-c3ae71dcb4ea4
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCD5a2e9bef-42cb-4b72-9a26-c3ae71dcb4ea4
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSY5a2e9bef-42cb-4b72-9a26-c3ae71dcb4ea4
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSY5a2e9bef-42cb-4b72-9a26-c3ae71dcb4ea4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0958-21001130958211 BOTTLE in 1 CARTON (0113-0958-21) / 89 mL in 1 BOTTLE1 bottle2013-06-200000-00-00NoNoCurrent
0113-0958-28001130958281 BOTTLE in 1 CARTON (0113-0958-28) / 148 mL in 1 BOTTLE1 bottle2013-07-250000-00-00NoNoCurrent