Home NDC 65852-010 Giltuss D
Product NDC 65852-010
11-digit product format 658520010
Labeler code 65852
Product ID 65852-010_3f17eefb-b626-b0f2-e063-6294a90afd4d
Type HUMAN OTC DRUG
Nonproprietary name Giltuss D
Dosage form SYRUP
Route ORAL
Labeler Dextrum Laboratories Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-04-11
Substance PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE
Active strength 10; 3.5 mg/10mL; mg/10mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
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 D
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENYLEPHRINE HYDROCHLORIDE 10 mg/10mL CHLORPHENIRAMINE MALEATE 3.5 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 04JA59TNSJ Internal UNII lookup V1Q0O9OJ9Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2724415 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 65852-010-04 Giltuss D 1 in 1 CARTON SYRUP 1 1 65852-010-04 Giltuss D 118 mL in 1 BOTTLE, PLASTIC SYRUP 118 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 123 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 65852-010-04 65852001004 1 BOTTLE, PLASTIC in 1 CARTON (65852-010-04) / 118 mL in 1 BOTTLE, PLASTIC 2024-04-11 No No Current