Home NDC 83324-324 Tussin DM
Product NDC 83324-324
11-digit product format 833240324
Labeler code 83324
Product ID 83324-324_869af78f-24e1-4ff3-bfaf-e27a0e6213ed
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Guaifenesin
Dosage form SOLUTION
Route ORAL
Labeler Chain Drug Marketing Association, Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-09-04
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 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 DM
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 20 mg/20mL GUAIFENESIN 400 mg/20mL
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 1020138 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 83324-324-04 Tussin DM 118 mL in 1 BOTTLE, PLASTIC SOLUTION 118 2 83324-324-04 Tussin DM 1 in 1 CARTON SOLUTION 1 2 83324-324-08 Tussin DM 237 mL in 1 BOTTLE, PLASTIC SOLUTION 237 2 83324-324-08 Tussin DM 1 in 1 CARTON SOLUTION 1 2
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 73 of 178 · 3,551 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 83324-324-04 83324032404 1 BOTTLE, PLASTIC in 1 CARTON (83324-324-04) / 118 mL in 1 BOTTLE, PLASTIC 2025-09-04 No No Current 83324-324-08 83324032408 1 BOTTLE, PLASTIC in 1 CARTON (83324-324-08) / 237 mL in 1 BOTTLE, PLASTIC 2025-09-04 No No Current