Home NDC 53113-515 Dr. SANA COUGH AND CHEST CONGESTION DM SUGAR FREE
Product NDC 53113-515
11-digit product format 531130515
Labeler code 53113
Product ID 53113-515_9ceb7b56-c0ce-49d6-abfe-cf07d08ed60c
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan Hydrobromide, Guaifenesin
Dosage form SYRUP
Route ORAL
Labeler GADAL Laboratories, Inc
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-04-14
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 20; 200 mg/30mL; mg/30mL
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 Dr. SANA COUGH AND CHEST CONGESTION DM SUGAR FREE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 20 mg/30mL GUAIFENESIN 200 mg/30mL
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 2719927 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 53113-515-06 Dr. SANA COUGH AND CHEST CONGESTION DM SUGAR FREE 1 in 1 BOX SYRUP 1 2 53113-515-06 Dr. SANA COUGH AND CHEST CONGESTION DM SUGAR FREE 180 mL in 1 BOTTLE SYRUP 180 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 Units Marketing start Sample Exclude flag Status 53113-515-06 53113051506 1 BOTTLE in 1 BOX (53113-515-06) / 180 mL in 1 BOTTLE 1 bottle 2025-04-14 No No Current