FDA.reportPublic FDA data

DM Max

Product NDC
53942-518
11-digit product format
539420518
Labeler code
53942
Product ID
53942-518_624db239-5bb9-43a0-af86-50865bf7718c
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTROMETHORPHAN HBR, GUAIFENESIN
Dosage form
SOLUTION
Route
ORAL
Labeler
DeMoulas Market Basket
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DM Max
Brand name suffix
CONGESTION and COUGH
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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53942-518-25DM MaxCONGESTION and COUGH177 mL in 1 BOTTLESOLUTION1772

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSNb12e26b2-79e4-45a5-9a90-4630f92457d02
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDb12e26b2-79e4-45a5-9a90-4630f92457d02
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSYb12e26b2-79e4-45a5-9a90-4630f92457d02
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYb12e26b2-79e4-45a5-9a90-4630f92457d02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53942-518-2553942051825177 mL in 1 BOTTLE (53942-518-25) 177 ml2026-01-01NoNoHistorical