Home NDC 76281-503 TUSSIN COUGH
Product NDC 76281-503
11-digit product format 762810503
Labeler code 76281
Product ID 76281-503_5b440237-78c8-458a-b365-8b77ae10fdd3
Type HUMAN OTC DRUG
Nonproprietary name DEXTROMETHORPHAN HYDROBROMIDE
Dosage form LIQUID
Route ORAL
Labeler AptaPharma Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-09-30
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 10; 100 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 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 COUGH
Brand name suffix EXPECTORANT COUGH SUPRESSANT DM
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5mL GUAIFENESIN 100 mg/5mL
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76281-503-24 TUSSIN COUGHEXPECTORANT COUGH SUPRESSANT DM 118 mL in 1 BOTTLE LIQUID 118 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76281-503 TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM (DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [APTAPHARMA INC.] 5 Current NDC, Legacy NDC, 1 package rows 20231231_8a4c55d0-c472-4e89-9fdb-17ecf0af4856.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 76281-503-24 76281050324 118 mL in 1 BOTTLE (76281-503-24) 118 ml 2020-09-30 0000-00-00 No No Current