Home NDC 65923-094 Iodent Oral Analgesic
Product NDC 65923-094
11-digit product format 659230094
Labeler code 65923
Product ID 65923-094_4262e1af-6041-bc2d-e063-6294a90a006f
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine
Dosage form GEL
Route TOPICAL
Labeler United Exchange Corp.
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-01-02
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 Iodent Oral Analgesic
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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65923-094-11 Iodent Oral Analgesic 11.9 g in 1 TUBE GEL 11.9 8 65923-094-11 Iodent Oral Analgesic 1 in 1 CARTON GEL 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65923-094 IODENT ORAL ANALGESIC (BENZOCAINE) GEL [UNITED EXCHANGE CORP.] 7 Current NDC, Legacy NDC, 2 package rows 20241215_63902125-f8dc-0ada-e053-2991aa0a7ce5.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 65923-094-11 65923009411 1 TUBE in 1 CARTON (65923-094-11) / 11.9 g in 1 TUBE 1 tube 2018-01-02 0000-00-00 No No Current