Home NDC 0404-0035 Benzo-Jel
Product NDC 0404-0035
11-digit product format 004040035
Labeler code 0404
Product ID 0404-0035_2ad009bc-29cd-0ba6-e063-6294a90a7580
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine
Dosage form GEL
Route DENTAL
Labeler Henry Schein Inc.
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-05-01
Substance BENZOCAINE
Active strength 200 mg/g
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 200 mg/g
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 238910 Internal RxNorm lookup 1053444 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 0404-0035-30 Benzo-Jel 30 g in 1 JAR GEL 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0404-0035 BENZO-JEL (BENZOCAINE) GEL [HENRY SCHEIN INC.] 4 Current NDC, Legacy NDC, 1 package rows 20250105_84e8d5c8-2a35-4179-9a9c-9a4a52c2cae6.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 Units Marketing start Marketing end Sample Exclude flag Status 0404-0035-30 00404003530 30 g in 1 JAR (0404-0035-30) 30 g 2018-06-01 0000-00-00 No No Current