FDA.reportPublic FDA data

tussin dm max

Product NDC
30142-843
11-digit product format
301420843
Labeler code
30142
Product ID
30142-843_a25493e2-4202-49b6-90cb-d5293c29088e
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
Kroger Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-06-28
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
30142-843-26tussin dm max1 in 1 CARTONSOLUTION15
30142-843-26tussin dm max118 mL in 1 BOTTLESOLUTION1185

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-843TUSSIN DM MAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [KROGER COMPANY]4Current NDC, Legacy NDC, 2 package rows20241106_be9aaf66-6c59-4042-88e2-acd920dcf992.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSNbe9aaf66-6c59-4042-88e2-acd920dcf9925
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDbe9aaf66-6c59-4042-88e2-acd920dcf9925
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSYbe9aaf66-6c59-4042-88e2-acd920dcf9925
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYbe9aaf66-6c59-4042-88e2-acd920dcf9925

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-843-26301420843261 BOTTLE in 1 CARTON (30142-843-26) / 118 mL in 1 BOTTLE1 bottle2018-06-280000-00-00NoNoCurrent