FDA.reportPublic FDA data

Good Sense Tussin DM Max

Product NDC
0113-0927
11-digit product format
001130927
Labeler code
0113
Product ID
0113-0927_5129c8fe-a209-476c-9bc0-2b362f7b5386
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
L. Perrigo Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-08-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 400 mg/20mL; mg/20mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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 Tussin DM Max
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL
GUAIFENESIN400 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1020138

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0113-0927-26Good Sense Tussin DM Max1 in 1 CARTONSOLUTION14
0113-0927-26Good Sense Tussin DM Max118 mL in 1 BOTTLESOLUTION1184
0113-0927-34Good Sense Tussin DM Max237 mL in 1 BOTTLESOLUTION2374
0113-0927-34Good Sense Tussin DM Max1 in 1 CARTONSOLUTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0927-26ML - Milliliter0113-09274f50659d-caac-4cc0-aaac-92c87733e78412022-04-06
0113-0927-34ML - Milliliter0113-0927d5cf41ad-bb5c-4ed9-90da-fe067c2ea3b712022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0927GOOD SENSE TUSSIN DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [L. PERRIGO COMPANY]4Current NDC, Legacy NDC, 4 package rows20241113_d2541ef0-a73c-43aa-91ff-fdbce2748c4f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSNd2541ef0-a73c-43aa-91ff-fdbce2748c4f4
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDd2541ef0-a73c-43aa-91ff-fdbce2748c4f4
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSYd2541ef0-a73c-43aa-91ff-fdbce2748c4f4
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYd2541ef0-a73c-43aa-91ff-fdbce2748c4f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0927-26001130927261 BOTTLE in 1 CARTON (0113-0927-26) / 118 mL in 1 BOTTLE1 bottle2018-08-060000-00-00NoNoCurrent
0113-0927-34001130927341 BOTTLE in 1 CARTON (0113-0927-34) / 237 mL in 1 BOTTLE1 bottle2018-08-010000-00-00NoNoCurrent