Home NDC 69676-0077 Cough and Chest Congestion Maximum Strength
Product NDC 69676-0077
11-digit product format 696760077
Labeler code 69676
Product ID 69676-0077_3857582e-3b04-90e9-e063-6294a90ab3d9
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Guaifenesin
Dosage form SUSPENSION
Route ORAL
Labeler Genexa Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-02-12
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 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Cough and Chest Congestion Maximum Strength
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 20 mg/20mL GUAIFENESIN 400 mg/20mL
Harmonized Identifiers# Field, Values table Field Values Unii 9D2RTI9KYH, 495W7451VQ
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 69676-0077-9 Cough and Chest Congestion Maximum Strength 177 mL in 1 BOTTLE, PLASTIC SUSPENSION 177 7 69676-0077-9 Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack 177 mL in 1 BOTTLE, PLASTIC SUSPENSION 177 mL 400 mg in 20mL 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69676-0077 COUGH AND CHEST CONGESTION MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN) SUSPENSION [GENEXA INC.] 6 Current NDC, Legacy NDC, 1 package rows 20250212_e920b700-30d3-3266-e053-2a95a90a0639.zip 69676-0077 MAXIMUM STRENGTH COUGH AND CHEST CONGESTION AND NIGHTTIME SEVERE COLD AND FLU COMBO PACK (DEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN, DOXYLAMINE SUCCINATE) KIT [GENEXA INC.] 1 Current NDC, Legacy NDC 20240905_18835205-a9e3-15c2-e063-6394a90a8107.zip
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 69676-0077-9 69676007709 177 mL in 1 BOTTLE, PLASTIC (69676-0077-9) 177 ml 2024-02-12 0000-00-00 No No Current