Home NDC 81923-369 INTIMALE Benzocaine Delay Gel
Product NDC 81923-369
11-digit product format 819230369
Labeler code 81923
Product ID 81923-369_0976eff9-48b9-1669-e063-6394a90a8240
Type HUMAN OTC DRUG
Nonproprietary name BENZOCAINE
Dosage form GEL
Route TOPICAL
Labeler SKINS SEXUAL HEALTH LIMITED
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-10-03
Substance BENZOCAINE
Active strength 50 mg/mL
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 INTIMALE Benzocaine Delay Gel
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 50 mg/mL
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 81923-369-00 INTIMALE Benzocaine Delay Gel 15 mL in 1 BOTTLE GEL 15 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81923-369 INTIMALE BENZOCAINE DELAY GEL (BENZOCAINE) GEL [SKINS SEXUAL HEALTH LIMITED] 2 Current NDC, Legacy NDC, 1 package rows 20231106_b845bfd5-ab73-495f-97ef-e959bc6311d9.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 48 of 152 · 3,029 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 81923-369-00 81923036900 15 mL in 1 BOTTLE (81923-369-00) 15 ml 2022-10-03 0000-00-00 No No Current