FDA.reportPublic FDA data

LEADER TUSSIN CF

Product NDC
70000-0739
11-digit product format
700000739
Labeler code
70000
Product ID
70000-0739_b8bbcafc-ef05-4fe1-b3bd-91f3d84f67aa
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, dextromethorphan hydrobromide, guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
Cardinal Health 110, LLC. dba Leader
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-09-30
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
650; 20; 400 mg/20mL; 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 CF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/20mL
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL
GUAIFENESIN400 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9D2RTI9KYH, 495W7451VQ
Rxcui2680300

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0739-1LEADER TUSSIN CF118 mL in 1 BOTTLESOLUTION1182
70000-0739-1LEADER TUSSIN CF1 in 1 CARTONSOLUTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0739-1ML - Milliliter70000-0739758b92ed-5b52-4de4-93a4-7ff30d55ab5512026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2680300acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSNf4ffe87b-0a62-44ac-b84a-08cf77cda7f52
2680300acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDf4ffe87b-0a62-44ac-b84a-08cf77cda7f52
2680300acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSYf4ffe87b-0a62-44ac-b84a-08cf77cda7f52
2680300APAP 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSYf4ffe87b-0a62-44ac-b84a-08cf77cda7f52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70000-0739-1700000739011 BOTTLE in 1 CARTON (70000-0739-1) / 118 mL in 1 BOTTLE1 bottle2025-09-30NoNoHistorical