Home NDC 80425-0560 Lidocaine and Menthol
Product NDC 80425-0560
11-digit product format 804250560
Labeler code 80425
Product ID 80425-0560_44840256-4718-a719-e063-6394a90a5a14
Type HUMAN OTC DRUG
Nonproprietary name lidocaine and menthol
Dosage form PATCH
Route TRANSDERMAL
Labeler Advanced Rx of Tennessee, LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-06-12
Substance LIDOCAINE; MENTHOL
Active strength .04; .01 g/g; g/g
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 Lidocaine and Menthol
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE .04 g/g MENTHOL .01 g/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 98PI200987 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 1249758 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 Sample Exclude flag Status 80425-0560-1 80425056001 30 POUCH in 1 CARTON (80425-0560-1) / 1 PATCH in 1 POUCH / 10 g in 1 PATCH 30 pouch 2026-06-12 No No Current