Home NDC 65852-015 Giltuss Bucalsep
Product NDC 65852-015
11-digit product format 658520015
Labeler code 65852
Product ID 65852-015_3fa233dc-156d-1e95-e063-6294a90a8bbd
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine, Menthol, Zinc chloride
Dosage form SPRAY
Route ORAL; TOPICAL
Labeler Dextrum Laboratories Inc.
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-07-26
Substance ZINC CATION; BENZOCAINE; MENTHOL
Active strength .12; 6.5; .1 mg/100mL; mg/100mL; mg/100mL
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [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 Bucalsep
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC CATION .12 mg/100mL BENZOCAINE 6.5 mg/100mL MENTHOL .1 mg/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 13S1S8SF37 Internal UNII lookup U3RSY48JW5 Internal UNII lookup L7T10EIP3A Internal UNII 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 65852-015-01 Giltuss Bucalsep 1 in 1 CARTON SPRAY 1 1 65852-015-01 Giltuss Bucalsep 30 mL in 1 BOTTLE, PLASTIC SPRAY 30 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 15 of 40 · 786 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 65852-015-01 65852001501 1 BOTTLE, PLASTIC in 1 CARTON (65852-015-01) / 30 mL in 1 BOTTLE, PLASTIC 2018-07-26 No No Current