Home NDC 69676-0070 Childrens Cough and Chest Congestion
Product NDC 69676-0070
11-digit product format 696760070
Labeler code 69676
Product ID 69676-0070_2d95d5a4-34dd-e195-e063-6394a90a39da
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 2022-09-01
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 5; 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 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 Childrens Cough and Chest Congestion
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 5 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 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 69676-0070-9 Childrens Cough and Chest Congestion 118 mL in 1 BOTTLE SUSPENSION 118 1 69676-0070-9 Childrens Cough and Chest Congestion 1 in 1 CARTON SUSPENSION 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69676-0070 CHILDRENS COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HBR, GUAIFENESIN) SUSPENSION [GENEXA INC.] 1 Current NDC, 2 package rows 20250210_2d95d5a4-34dc-e195-e063-6394a90a39da.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 177 · 3,534 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69676-0070-9 69676007009 1 BOTTLE in 1 CARTON (69676-0070-9) / 118 mL in 1 BOTTLE 1 bottle 2022-09-01 No No Current