Home NDC 21130-583 Tussin DM Cough and Chest Congestion
Product NDC 21130-583
11-digit product format 211300583
Labeler code 21130
Product ID 21130-583_e3534cc1-edf9-482f-8462-8d08d36790f3
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Guaifenesin
Dosage form LIQUID
Route ORAL
Labeler Safeway, Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-12-01
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 DM Cough and Chest Congestion
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 21130-583-04 Tussin DM Cough and Chest Congestion 118 mL in 1 BOTTLE, PLASTIC LIQUID 118 1 21130-583-04 Tussin DM Cough and Chest Congestion 1 in 1 BOX LIQUID 1 1 21130-583-08 Tussin DM Cough and Chest Congestion 237 mL in 1 BOTTLE, PLASTIC LIQUID 237 1 21130-583-08 Tussin DM Cough and Chest Congestion 1 in 1 BOX LIQUID 1 1
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 21130-583-04 21130058304 1 BOTTLE, PLASTIC in 1 BOX (21130-583-04) / 118 mL in 1 BOTTLE, PLASTIC 2025-12-01 No No Current 21130-583-08 21130058308 1 BOTTLE, PLASTIC in 1 BOX (21130-583-08) / 237 mL in 1 BOTTLE, PLASTIC 2025-12-01 No No Current