FDA.reportPublic FDA data

Tussin DM Max

Product NDC
49035-930
11-digit product format
490350930
Labeler code
49035
Product ID
49035-930_66b4aaf2-4b23-452d-a264-d5f6c70f07c9
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-08-15
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tussin DM Max
Listing expiration
2027-12-31

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
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
49035-930-00Tussin DM Max237 mL in 1 BOTTLE, PLASTICSOLUTION23715
49035-930-19Tussin DM Max1 in 1 CARTONSOLUTION115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-930-19ML - Milliliter49035-930ce5d42b2-194f-46a3-b2a9-b4180ea4073412024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-930TUSSIN DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [WAL-MART STORES INC]13Current NDC, Legacy NDC, 2 package rows20250116_cc77f3a6-48ce-41b5-bf4e-5ed7d8c69e2c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSNcc77f3a6-48ce-41b5-bf4e-5ed7d8c69e2c15
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDcc77f3a6-48ce-41b5-bf4e-5ed7d8c69e2c15
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSYcc77f3a6-48ce-41b5-bf4e-5ed7d8c69e2c15
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYcc77f3a6-48ce-41b5-bf4e-5ed7d8c69e2c15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-930-0049035093000237 mL in 1 BOTTLE, PLASTIC237 mlHistorical
49035-930-19490350930191 BOTTLE, PLASTIC in 1 CARTON (49035-930-19) / 237 mL in 1 BOTTLE, PLASTIC (49035-930-00) 2018-08-150000-00-00NoNoCurrent