Home NDC 73564-804 Lidonex
Product NDC 73564-804
11-digit product format 735640804
Labeler code 73564
Product ID 73564-804_587aebb8-055f-b485-e063-6394a90acf8c
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine Hcl, Menthol
Dosage form LIQUID
Route TOPICAL
Labeler Aldama Pharmaceuticals, Inc
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-06-01
Substance MENTHOL; LIDOCAINE HYDROCHLORIDE
Active strength 5; 4 g/100mL; g/100mL
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 Lidonex
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 5 g/100mL LIDOCAINE HYDROCHLORIDE 4 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup V13007Z41A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2715395 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 73564-804-02 Lidonex 60 mL in 1 BOTTLE LIQUID 60 2
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 78 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 Sample Exclude flag Status 73564-804-02 73564080402 60 mL in 1 BOTTLE 60 ml Historical 73564-804-25 73564080425 74 mL in 1 BOTTLE (73564-804-25) 74 ml 2026-09-01 No No Current