Home NDC 49580-0834 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 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Tussin Cough Sugar Free
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 20 mg/10mL GUAIFENESIN 200 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 495W7451VQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 996520 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49580-0834-4 Tussin Cough Sugar Free 1 in 1 BOX LIQUID 1 2 49580-0834-4 Tussin Cough Sugar Free 118 mL in 1 BOTTLE, PLASTIC LIQUID 118 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49580-0834 TUSSIN COUGH SUGAR FREE (DEXTROMETHORPHAN HBR GUAIFENESIN) LIQUID [P & L DEVELOPMENT, LLC] 2 Current NDC, 2 package rows 20240731_7ed2fe86-3346-4308-a9b6-6a264f879b02.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 49580-0834-4 49580083404 1 BOTTLE, PLASTIC in 1 BOX (49580-0834-4) / 118 mL in 1 BOTTLE, PLASTIC 2024-07-31 No No Current