Home NDC 71205-715 Lidozen Gel
Product NDC 71205-715
11-digit product format 712050715
Labeler code 71205
Product ID 71205-715_aad2d2f0-c755-4506-9f59-81a6c3439094
Type HUMAN OTC DRUG
Nonproprietary name LIDOCAINE HYDROCHLORIDE, MENTHOL
Dosage form GEL
Route TOPICAL
Labeler Proficient Rx LP
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-09-01
Substance LIDOCAINE HYDROCHLORIDE; MENTHOL, UNSPECIFIED FORM
Active strength 40; 10 mg/mL; mg/mL
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 Lidozen Gel
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 40 mg/mL MENTHOL, UNSPECIFIED FORM 10 mg/mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1373137 Internal RxNorm lookup 1939340 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 71205-715-72 Lidozen Gel 120 mL in 1 BOTTLE GEL 120 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71205-715 LIDOZEN GEL (LIDOCAINE HYDROCHLORIDE, MENTHOL) GEL [PROFICIENT RX LP] 2 Current NDC, Legacy NDC, 1 package rows 20231207_7c300dec-cefd-4b79-a948-a917b7708a04.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.
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 71205-715-72 71205071572 120 mL in 1 BOTTLE (71205-715-72) 120 ml 2022-11-11 0000-00-00 No No Current