Home NDC 70000-0713 Tussin DM
Product NDC 70000-0713
11-digit product format 700000713
Labeler code 70000
Product ID 70000-0713_411d98ca-c3e4-dce1-e063-6294a90a9b0a
Type HUMAN OTC DRUG
Nonproprietary name dextromethorphan hydrobromide and guaifenesin
Dosage form SOLUTION
Route ORAL
Labeler Cardinal Health 110, Inc. DBA LEADER
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-10-07
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 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
Brand name suffix Cough plus Chest Congestion
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 20 mg/20mL GUAIFENESIN 200 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 1790650 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 70000-0713-1 Tussin DMCough plus Chest Congestion 1 in 1 CARTON SOLUTION 1 3 70000-0713-1 Tussin DMCough plus Chest Congestion 237 mL in 1 BOTTLE SOLUTION 237 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70000-0713 TUSSIN DM COUGH PLUS CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SOLUTION [CARDINAL HEALTH 110, INC. DBA LEADER] 2 Current NDC, 2 package rows 20241122_9d11f443-c93d-44e8-b5a3-2677b7b11212.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 73 of 178 · 3,551 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70000-0713-1 70000071301 1 BOTTLE in 1 CARTON (70000-0713-1) / 237 mL in 1 BOTTLE 1 bottle 2024-10-07 No No Current