Home NDC 81923-197 INTIMALE Maximum Strength Delay
Product NDC 81923-197
11-digit product format 819230197
Labeler code 81923
Product ID 81923-197_09e2a350-7cd3-0898-e063-6394a90ad3dc
Type HUMAN OTC DRUG
Nonproprietary name LIDOCAINE HYDROCHLORIDE
Dosage form SOLUTION
Route TOPICAL
Labeler SKINS SEXUAL HEALTH LIMITED
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-05-25
Substance LIDOCAINE HYDROCHLORIDE
Active strength 10 mg/mL
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
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 Maximum Strength Delay
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V13007Z41A 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 81923-197-00 INTIMALE Maximum Strength Delay 1 in 1 BOX SOLUTION 1 2 81923-197-00 INTIMALE Maximum Strength Delay 15 mL in 1 CYLINDER SOLUTION 15 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81923-197 INTIMALE MAXIMUM STRENGTH DELAY (LIDOCAINE HYDROCHLORIDE) SOLUTION [SKINS SEXUAL HEALTH LIMITED] 2 Current NDC, Legacy NDC, 2 package rows 20231112_25b9ade3-72b0-4b86-8c48-90310a26806f.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 18 of 153 · 3,057 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 81923-197-00 81923019700 1 CYLINDER in 1 BOX (81923-197-00) / 15 mL in 1 CYLINDER 1 cylinder 2021-05-25 0000-00-00 No No Current