FDA.reportPublic FDA data

Tussin DM

Product NDC
83324-324
11-digit product format
833240324
Labeler code
83324
Product ID
83324-324_11c5d1e4-2253-4b57-bb14-4e9ed77e7426
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
Chain Drug Marketing Association, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-09-04
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
Tussin DM
Listing expiration
2027-12-31

Active Ingredients#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-324-04Tussin DM118 mL in 1 BOTTLE, PLASTICSOLUTION1182
83324-324-04Tussin DM1 in 1 CARTONSOLUTION12
83324-324-08Tussin DM237 mL in 1 BOTTLE, PLASTICSOLUTION2372
83324-324-08Tussin DM1 in 1 CARTONSOLUTION12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSNb0d38db9-22a9-4dd8-8e0f-dd81805e724b2
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDb0d38db9-22a9-4dd8-8e0f-dd81805e724b2
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSYb0d38db9-22a9-4dd8-8e0f-dd81805e724b2
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYb0d38db9-22a9-4dd8-8e0f-dd81805e724b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83324-324-04833240324041 BOTTLE, PLASTIC in 1 CARTON (83324-324-04) / 118 mL in 1 BOTTLE, PLASTIC2025-09-04NoNoHistorical
83324-324-08833240324081 BOTTLE, PLASTIC in 1 CARTON (83324-324-08) / 237 mL in 1 BOTTLE, PLASTIC2025-09-04NoNoHistorical