Home NDC 71363-101 Astra-dent Topical Anesthetic Gel
Product NDC 71363-101
11-digit product format 713630101
Labeler code 71363
Product ID 71363-101_2b4801fa-2b9b-9b91-e063-6294a90a7ebf
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine
Dosage form GEL
Route DENTAL
Labeler Zag Usa Inc
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-07-01
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 Astra-dent Topical Anesthetic Gel
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 71363-101-30 Astra-dent Topical Anesthetic Gel 28 g in 1 JAR GEL 28 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71363-101 ASTRA-DENT TOPICAL ANESTHETIC GEL (BENZOCAINE) GEL [ZAG USA INC] 4 Current NDC, Legacy NDC, 1 package rows 20250112_56185c5f-6f6c-4976-bf18-540b076d90a6.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 41 · 818 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 71363-101-30 71363010130 28 g in 1 JAR (71363-101-30) 28 g 2018-08-01 0000-00-00 No No Current