Tussin Cough Sugar Free

Product NDC
49580-0834
11-digit product format
495800834
Labeler code
49580
Product ID
49580-0834_e47f5029-661a-497e-aa8e-55520700b8d4
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
P & L Development, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-31
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 200 mg/10mL; mg/10mL
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
9D2RTI9KYHDEXTROMETHORPHAN HYDROBROMIDE6700-34-1DEXTROMETHORPHAN HYDROBROMIDE
495W7451VQGUAIFENESIN93-14-1GUAIFENESIN

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
49580-0834-4495800834041 BOTTLE, PLASTIC in 1 BOX (49580-0834-4) / 118 mL in 1 BOTTLE, PLASTIC2024-07-31NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Drug FactsP & L Development, LLC2024-05-09HUMAN OTC DRUG LABEL2