Home NDC 53045-138 Iolite
Product NDC 53045-138
11-digit product format 530450138
Labeler code 53045
Product ID 53045-138_8e01b193-fdc4-4ea8-94a9-7f2b30fe806b
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine
Dosage form GEL
Route DENTAL; ORAL
Labeler Dharma Research, Inc.
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-07-23
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 Iolite
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 53045-138-30 Iolite 32 g in 1 BOTTLE GEL 32 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53045-138 IOLITE (BENZOCAINE) GEL [DHARMA RESEARCH, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20231011_414cbec9-94e2-4bca-908b-1e79f8db0b27.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53045-138-30 53045013830 32 g in 1 BOTTLE (53045-138-30) 32 g 2017-07-23 0000-00-00 No No Current