Home NDC 72189-621 Lidothol Gel
Product NDC 72189-621
11-digit product format 721890621
Labeler code 72189
Product ID 72189-621_4d3a4f73-0e3f-76f6-e063-6394a90aee8b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidothol Gel
Dosage form GEL
Route CUTANEOUS
Labeler Direct_Rx
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2025-05-12
Substance LIDOCAINE HYDROCHLORIDE; MENTHOL
Active strength 4.5; 5 g/100g; g/100g
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
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 Lidothol Gel
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 4.5 g/100g MENTHOL 5 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V13007Z41A Internal UNII lookup L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2257313 Internal RxNorm 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 72189-621-35 Lidothol Gel 1 g in 1 BOX GEL 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72189-621 LIDOTHOL GEL GEL [DIRECT_RX] 1 Current NDC, 1 package rows 20250523_34f15ceb-87c1-526d-e063-6294a90a3789.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 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72189-621-35 72189062135 1 g in 1 BOX (72189-621-35) 1 g 2025-05-12 No No Current