Home NDC 0904-7513 Guaifenesin and Dextromethorphan
Product NDC 0904-7513
11-digit product format 009047513
Labeler code 0904
Product ID 0904-7513_f4e2de93-edd9-4f0f-ab5c-305bf82ca380
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin and Dextromethorphan
Dosage form SYRUP
Route ORAL
Labeler Major Pharmaceuticals
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-02-10
Substance GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 200; 20 mg/10mL; mg/10mL
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
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 200 mg/10mL DEXTROMETHORPHAN HYDROBROMIDE 20 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 495W7451VQ Internal UNII lookup 9D2RTI9KYH 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 0904-7513-66 Guaifenesin and Dextromethorphan 10 mL in 1 CUP, UNIT-DOSE SYRUP 10 3 0904-7513-72 Guaifenesin and Dextromethorphan 10 in 1 CASE SYRUP 10 3 0904-7513-72 Guaifenesin and Dextromethorphan 10 in 1 TRAY SYRUP 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-7513 GUAIFENESIN AND DEXTROMETHORPHAN SYRUP [MAJOR PHARMACEUTICALS] 3 Current NDC, 3 package rows 20250211_51e48201-bb62-4e89-85eb-e4a416f93522.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 0904-7513-66 00904751366 10 mL in 1 CUP, UNIT-DOSE 10 ml Historical 0904-7513-72 00904751372 10 TRAY in 1 CASE (0904-7513-72) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0904-7513-66) 10 tray 2025-02-10 No No Current