Home NDC 73564-802 Guaifed DM
Product NDC 73564-802
11-digit product format 735640802
Labeler code 73564
Product ID 73564-802_58b4e715-186f-6cc6-e063-6294a90af150
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan, Guaifenesin
Dosage form LIQUID
Route ORAL
Labeler Aldama Pharmaceuticals, Inc
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-06-01
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 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 Guaifed DM
Listing expiration 2027-12-31 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 73564-802-04 Guaifed DM 118 mL in 1 BOTTLE LIQUID 118 4 73564-802-08 Guaifed DM 237 mL in 1 BOTTLE LIQUID 237 4 73564-802-16 Guaifed DM 473 mL in 1 BOTTLE LIQUID 473 4
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 73564-802-04 73564080204 118 mL in 1 BOTTLE (73564-802-04) 118 ml 2026-06-01 No No Current 73564-802-08 73564080208 237 mL in 1 BOTTLE 237 ml Historical 73564-802-16 73564080216 473 mL in 1 BOTTLE 473 ml Historical