Home NDC 51316-305 Cough and Chest Congestion DM
Product NDC 51316-305
11-digit product format 513160305
Labeler code 51316
Product ID 51316-305_6240de4a-e200-4b0f-b5d2-c38b4e2c1401
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Guaifenesin
Dosage form SOLUTION
Route ORAL
Labeler CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-02-25
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 Cough and Chest Congestion DM
Brand name suffix Daytime
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 51316-305-19 Cough and Chest Congestion DMDaytime 1 in 1 CARTON SOLUTION 1 2 51316-305-19 Cough and Chest Congestion DMDaytime 237 mL in 1 BOTTLE, PLASTIC SOLUTION 237 2 51316-305-36 Cough and Chest Congestion DMDaytime 1 in 1 CARTON SOLUTION 1 2 51316-305-36 Cough and Chest Congestion DMDaytime 118 mL in 1 BOTTLE, PLASTIC SOLUTION 118 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 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 51316-305-19 51316030519 1 BOTTLE, PLASTIC in 1 CARTON (51316-305-19) / 237 mL in 1 BOTTLE, PLASTIC 2026-02-25 No No Current 51316-305-36 51316030536 1 BOTTLE, PLASTIC in 1 CARTON (51316-305-36) / 118 mL in 1 BOTTLE, PLASTIC 2026-02-25 No No Current