Home NDC 58657-504 Guaifenesin and Dextromethorphan Hydrobromide
Product NDC 58657-504
11-digit product format 586570504
Labeler code 58657
Product ID 58657-504_41b4eb73-e463-24b0-e063-6394a90a6cc0
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin and Dextromethorphan Hydrobromide
Dosage form SYRUP
Route ORAL
Labeler Method Pharmaceuticals
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-04-01
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 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 Guaifenesin and Dextromethorphan Hydrobromide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 10 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 996520 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 58657-504-08 Guaifenesin and Dextromethorphan Hydrobromide 237 mL in 1 BOTTLE, PLASTIC SYRUP 237 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58657-504 GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [METHOD PHARMACEUTICALS] 2 Current NDC, 1 package rows 20240509_1538bf63-d020-3ba2-e063-6294a90aecc5.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 74 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 Sample Exclude flag Status 58657-504-08 58657050408 237 mL in 1 BOTTLE, PLASTIC (58657-504-08) 237 ml 2024-04-01 No No Current