Home NDC 53045-147 Avant
Product NDC 53045-147
11-digit product format 530450147
Labeler code 53045
Product ID 53045-147_060fda3c-b1f4-41b0-bb18-d276f9975924
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine
Dosage form GEL
Route DENTAL
Labeler Dharma Research, Inc.
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-01-22
Substance BENZOCAINE
Active strength 6.4 g/100g
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 Avant
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 6.4 g/100g
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 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 53045-147-30 Avant 32 g in 1 BOTTLE GEL 32 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53045-147 AVANT (BENZOCAINE) GEL [DHARMA RESEARCH, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20231012_e10c45e6-d37f-4650-b3e5-07719cc0ea49.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 26 of 39 · 774 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53045-147-30 53045014730 32 g in 1 BOTTLE (53045-147-30) 32 g 2021-01-22 0000-00-00 No No Current