Home NDC 65852-008 Giltuss EX Expectorant
Product NDC 65852-008
11-digit product format 658520008
Labeler code 65852
Product ID 65852-008_3f67ac3d-1504-3418-e063-6394a90a938f
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin
Dosage form SOLUTION
Route ORAL
Labeler Dextrum Laboratories Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-06-22
Substance GUAIFENESIN
Active strength 400 mg/10mL
Pharmacologic classes Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
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 EX Expectorant
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 400 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 310625 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 65852-008-04 Giltuss EX Expectorant 118 mL in 1 BOTTLE, PLASTIC SOLUTION 118 1 65852-008-04 Giltuss EX Expectorant 1 in 1 CARTON SOLUTION 1 1
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 65852-008-04 65852000804 1 BOTTLE, PLASTIC in 1 CARTON (65852-008-04) / 118 mL in 1 BOTTLE, PLASTIC 2020-06-22 No No Current