Home NDC 61787-515 Diabetic Tussin DM Maximum Strength
Product NDC 61787-515
11-digit product format 617870515
Labeler code 61787
Product ID 61787-515_e60166fa-5c2e-4449-9633-97607116cbe5
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan Hydrobromide and Guaifenesin
Dosage form LIQUID
Route ORAL
Labeler MEDTECH PRODUCTS INC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-02-01
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 20; 400 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 Diabetic Tussin DM Maximum Strength
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 20 mg/10mL GUAIFENESIN 400 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 1046631 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61787-515-04 Diabetic Tussin DM Maximum Strength 1 in 1 BOX LIQUID 1 5 61787-515-04 Diabetic Tussin DM Maximum Strength 118 mL in 1 BOTTLE LIQUID 118 5 61787-515-08 Diabetic Tussin DM Maximum Strength 237 mL in 1 BOTTLE LIQUID 237 5 61787-515-08 Diabetic Tussin DM Maximum Strength 1 in 1 BOX LIQUID 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61787-515 DIABETIC TUSSIN DM MAXIMUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [MEDTECH PRODUCTS INC] 4 Current NDC, Legacy NDC, 4 package rows 20240704_a10a3b33-7503-4334-8ed7-2bb881df4327.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 Units Marketing start Marketing end Sample Exclude flag Status 61787-515-04 61787051504 1 BOTTLE in 1 BOX (61787-515-04) / 118 mL in 1 BOTTLE 1 bottle 2020-02-01 0000-00-00 No No Current 61787-515-08 61787051508 1 BOTTLE in 1 BOX (61787-515-08) / 237 mL in 1 BOTTLE 1 bottle 2020-02-01 0000-00-00 No No Current