Home NDC 84415-014 Dextromethorphan HBr. and Guaifenesin
Product NDC 84415-014
11-digit product format 844150014
Labeler code 84415
Product ID 84415-014_5cca83db-66f8-4029-e063-6394a90aa7a0
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr. and Guaifenesin
Dosage form SOLUTION
Route ORAL
Labeler Everpharm LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-01-16
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 Dextromethorphan HBr. and Guaifenesin
Listing expiration 2026-12-31 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 84415-014-01 Dextromethorphan HBr. and Guaifenesin 5 mL in 1 CUP, UNIT-DOSE SOLUTION 5 1 84415-014-01 Dextromethorphan HBr. and Guaifenesin 100 in 1 BOX, UNIT-DOSE SOLUTION 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84415-014 DEXTROMETHORPHAN HBR. AND GUAIFENESIN SOLUTION [EVERPHARM LLC] 1 Current NDC, 2 package rows 20250119_0c7cd5c4-459d-4e42-ae22-b94f2e29cffb.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 Marketing start Sample Exclude flag Status 84415-014-01 84415001401 100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (84415-014-01) / 5 mL in 1 CUP, UNIT-DOSE 2025-01-16 No No Current