Home NDC 0404-0018 Benzo Jel
Product NDC 0404-0018
11-digit product format 004040018
Labeler code 0404
Product ID 0404-0018_1172e39c-cc41-33c5-e063-6294a90a8d4b
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine
Dosage form SPRAY, METERED
Route DENTAL
Labeler Henry Schein Inc.
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-02-01
Substance BENZOCAINE
Active strength 11.4 g/57g
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [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 Benzo Jel
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 11.4 g/57g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3RSY48JW5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 360348 Internal RxNorm lookup 1742420 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0404-0018-35 Benzo Jel 57 g in 1 BOTTLE, SPRAY SPRAY, METERED 57 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0404-0018 BENZO JEL (BENZOCAINE) SPRAY, METERED [HENRY SCHEIN INC.] 6 Current NDC, Legacy NDC, 1 package rows 20240217_2cd571fc-30ee-40da-a2c7-25adb7d4b5c3.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 31 of 55 · 1,088 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0404-0018-35 00404001835 57 g in 1 BOTTLE, SPRAY (0404-0018-35) 57 g 2016-02-01 0000-00-00 No No Current