Home NDC 65852-009 Giltuss Diabetic
Product NDC 65852-009
11-digit product format 658520009
Labeler code 65852
Product ID 65852-009_40806093-e562-0be7-e063-6294a90a949c
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan hydrobromide, Guaifenesin
Dosage form SOLUTION
Route ORAL
Labeler Dextrum Laboratories, Inc
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-10-17
Substance DEXTROMETHORPHAN HYDROCHLORIDE; GUAIFENESIN
Active strength 20; 200 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 Giltuss Diabetic
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROCHLORIDE 20 mg/10mL GUAIFENESIN 200 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 351KFH969D 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 65852-009-04 Giltuss Diabetic 1 in 1 CARTON SOLUTION 1 2 65852-009-04 Giltuss Diabetic 118 mL in 1 BOTTLE, PLASTIC SOLUTION 118 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 73 of 178 · 3,551 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 65852-009-04 65852000904 1 BOTTLE, PLASTIC in 1 CARTON (65852-009-04) / 118 mL in 1 BOTTLE, PLASTIC 2018-10-17 No No Current