Home NDC 85722-0002 DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN
Product NDC 85722-0002
11-digit product format 857220002
Labeler code 85722
Product ID 85722-0002_9cb5da4e-9175-4339-83da-fc22448b2e80
Type HUMAN OTC DRUG
Nonproprietary name DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN
Dosage form SYRUP
Route ORAL
Labeler KJD Pharma Private Limited
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-02-01
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 20; 300 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 DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 20 mg/5mL GUAIFENESIN 300 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 1117394 Internal RxNorm 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 85722-0002-4 DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN 118 mL in 1 BOTTLE SYRUP 118 2 85722-0002-6 DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN 473 mL in 1 BOTTLE SYRUP 473 2 85722-0002-8 DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN 236 mL in 1 BOTTLE SYRUP 236 2
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 98 of 178 · 3,551 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85722-0002-4 85722000204 118 mL in 1 BOTTLE (85722-0002-4) 118 ml 2021-02-01 No No Current 85722-0002-6 85722000206 473 mL in 1 BOTTLE (85722-0002-6) 473 ml 2021-02-01 No No Current 85722-0002-8 85722000208 236 mL in 1 BOTTLE (85722-0002-8) 236 ml 2021-02-01 No No Current