Home NDC 69498-003 iSmile Topical Anesthetic
Product NDC 69498-003
11-digit product format 694980003
Labeler code 69498
Product ID 69498-003_2b4cfd5e-bd83-534d-e063-6394a90a598c
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine
Dosage form GEL
Route DENTAL
Labeler iSmile Dental Products, Inc.
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-06-01
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 iSmile Topical Anesthetic
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 238910 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 69498-003-30 iSmile Topical Anesthetic 30 g in 1 JAR GEL 30 4
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69498-003 ISMILE TOPICAL ANESTHETIC (BENZOCAINE) GEL [ISMILE DENTAL PRODUCTS, INC.] 4 Current NDC, Legacy NDC, 1 package rows 20250112_1d6a1182-ab63-460a-ab91-8d4c2ae5d01e.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 29 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 69498-003-30 69498000330 30 g in 1 JAR (69498-003-30) 30 g 2018-06-01 0000-00-00 No No Current