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 GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 400; 20 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 Maximum Strength
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 400 mg/20mL DEXTROMETHORPHAN HYDROBROMIDE 20 mg/20mL
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 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 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
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 73 of 178 · 3,550 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 69676-0077-9 69676007709 177 mL in 1 BOTTLE, PLASTIC (69676-0077-9) 177 ml 2024-02-12 0000-00-00 No No Current