Home NDC 69729-035 DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN
Product NDC 69729-035
11-digit product format 697290035
Labeler code 69729
Product ID 69729-035_5d208b0e-4c1e-33a3-e063-6394a90a806d
Type HUMAN OTC DRUG
Nonproprietary name DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN
Dosage form SYRUP
Route ORAL
Labeler OPMX LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-02-01
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 DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5mL GUAIFENESIN 100 mg/5mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69729-035-04 DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN 118 mL in 1 BOTTLE SYRUP 118 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69729-035 DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN SYRUP [OPMX LLC] 6 Current NDC, Legacy NDC, 1 package rows 20250516_8bb85b23-e9f6-48c7-84b0-15e0e26df4c5.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 153 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 69729-035-04 69729003504 118 mL in 1 BOTTLE (69729-035-04) 118 ml 2021-02-01 0000-00-00 No No Current