Home NDC 58552-135 Giltuss Bucalsep
Product NDC 58552-135
11-digit product format 585520135
Labeler code 58552
Product ID 58552-135_40b86bd0-283d-5043-e063-6394a90ada9c
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine, Menthol, Zinc chloride
Dosage form SPRAY
Route ORAL; TOPICAL
Labeler Gil Pharmaceutical Corp
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-07-26
Substance BENZOCAINE; MENTHOL; ZINC CHLORIDE
Active strength 6.5; .1; .12 g/100mL; g/100mL; g/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 BENZOCAINE 6.5 g/100mL MENTHOL .1 g/100mL ZINC CHLORIDE .12 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3RSY48JW5 Internal UNII lookup L7T10EIP3A Internal UNII lookup 86Q357L16B Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2170427 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58552-135-01 Giltuss Bucalsep 1 in 1 CARTON SPRAY 1 6 58552-135-01 Giltuss Bucalsep 30 mL in 1 BOTTLE, SPRAY SPRAY 30 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58552-135 GILTUSS BUCALSEP (BENZOCAINE, MENTHOL, ZINC CHLORIDE) SPRAY [GIL PHARMACEUTICAL CORP] 5 Current NDC, Legacy NDC, 2 package rows 20241027_85053391-8d71-ab4f-e053-2991aa0a7e08.zip
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 9 of 40 · 786 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 58552-135-01 58552013501 1 BOTTLE, SPRAY in 1 CARTON (58552-135-01) / 30 mL in 1 BOTTLE, SPRAY 2018-07-26 0000-00-00 No No Current