Home NDC 57237-360 Mucolyte
Product NDC 57237-360
11-digit product format 572370360
Labeler code 57237
Product ID 57237-360_e0d8faa2-7ca9-49c9-bae0-138fea576c68
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin, Dextromethorphan HBr
Dosage form LIQUID
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-12-22
Substance GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 100; 10 mg/5mL; mg/5mL
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 Mucolyte
Brand name suffix DM
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 100 mg/5mL DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 495W7451VQ Internal UNII lookup 9D2RTI9KYH 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 57237-360-12 MucolyteDM 118 mL in 1 BOTTLE LIQUID 118 1 57237-360-16 MucolyteDM 473 mL in 1 BOTTLE LIQUID 473 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 98 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 Sample Exclude flag Status 57237-360-12 57237036012 118 mL in 1 BOTTLE (57237-360-12) 118 ml 2025-12-22 No No Current 57237-360-16 57237036016 473 mL in 1 BOTTLE (57237-360-16) 473 ml 2025-12-22 No No Current