Home NDC 70000-0628 Tussin DM
Product NDC 70000-0628
11-digit product format 700000628
Labeler code 70000
Product ID 70000-0628_fdd29509-3ad8-4f32-8705-d97931093228
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Guaifenesin
Dosage form SOLUTION
Route ORAL
Labeler Cardinal Health 110, LLC. DBA Leader
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-03-16
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
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70000-0628-1 Tussin DM 1 in 1 CARTON SOLUTION 1 7 70000-0628-1 Tussin DM 118 mL in 1 BOTTLE, PLASTIC SOLUTION 118 7 70000-0628-2 Tussin DM 1 in 1 CARTON SOLUTION 1 7 70000-0628-2 Tussin DM 237 mL in 1 BOTTLE, PLASTIC SOLUTION 237 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70000-0628 TUSSIN DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [CARDINAL HEALTH 110, LLC. DBA LEADER] 5 Current NDC, 4 package rows 20240702_c63ef4a0-bbc2-4e6f-9354-225e494314bc.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 97 of 178 · 3,550 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 70000-0628-1 70000062801 1 BOTTLE, PLASTIC in 1 CARTON (70000-0628-1) / 118 mL in 1 BOTTLE, PLASTIC 2023-03-16 No No Current 70000-0628-2 70000062802 1 BOTTLE, PLASTIC in 1 CARTON (70000-0628-2) / 237 mL in 1 BOTTLE, PLASTIC 2023-03-16 No No Current