FDA.reportPublic FDA data

leader tussin dm

Product NDC
70000-0596
11-digit product format
700000596
Labeler code
70000
Product ID
70000-0596_19e85362-406a-45fd-8efe-5e12cbbb610c
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan hydrobromide, guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
Cardinal Health 110, LLC. dba Leader
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-11-24
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 200 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
leader tussin dm
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL
GUAIFENESIN200 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1790650

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
70000-0596-1leader tussin dm118 mL in 1 BOTTLESOLUTION1182
70000-0596-1leader tussin dm1 in 1 CARTONSOLUTION12
70000-0596-2leader tussin dm237 mL in 1 BOTTLESOLUTION2372
70000-0596-2leader tussin dm1 in 1 CARTONSOLUTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0596-1ML - Milliliter70000-05969b2c7047-9805-4e30-92f8-6f5852a097e812025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0596LEADER TUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CARDINAL HEALTH 110, LLC. DBA LEADER]2Current NDC, Legacy NDC, 4 package rows20241112_b418c10c-528b-4395-944e-af959b639ec2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1790650dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 10 mL Oral SolutionPSNb418c10c-528b-4395-944e-af959b639ec22
1790650dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML Oral SolutionSCDb418c10c-528b-4395-944e-af959b639ec22
1790650dextromethorphan HBr 10 MG / guaifenesin 100 MG per 10 ML Oral SolutionSYb418c10c-528b-4395-944e-af959b639ec22
1790650dextromethorphan HBr 20 MG / guaifenesin 200 MG per 20 ML Oral SolutionSYb418c10c-528b-4395-944e-af959b639ec22
1790650dextromethorphan HBr 5 MG / guaifenesin 50 MG per 5 ML Oral SolutionSYb418c10c-528b-4395-944e-af959b639ec22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0596-1700000596011 BOTTLE in 1 CARTON (70000-0596-1) / 118 mL in 1 BOTTLE1 bottle2021-11-240000-00-00NoNoCurrent
70000-0596-2700000596021 BOTTLE in 1 CARTON (70000-0596-2) / 237 mL in 1 BOTTLE1 bottle2021-11-240000-00-00NoNoCurrent