Home NDC 82461-416 Lidocaine Patch 4%
Product NDC 82461-416
11-digit product format 824610416
Labeler code 82461
Product ID 82461-416_bf38c2df-2b08-430e-8272-c9975d2e8e38
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine 4%
Dosage form PATCH
Route TRANSDERMAL
Labeler Medcore LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-05-18
Substance LIDOCAINE
Active strength 40 mg/g
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 Lidocaine Patch 4%
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE 40 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 98PI200987 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1737778 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 82461-416-30 Lidocaine Patch 4% 6 in 1 BOX PATCH 6 1 82461-416-30 Lidocaine Patch 4% 5 g in 1 POUCH PATCH 5 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82461-416 LIDOCAINE PATCH 4% (LIDOCAINE 4%) PATCH [MEDCORE LLC] 1 Current NDC, 2 package rows 20250519_b961906c-fe66-466b-af2c-072781fa098b.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 97 of 151 · 3,010 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 82461-416-30 82461041630 6 POUCH in 1 BOX (82461-416-30) / 5 g in 1 POUCH 6 pouch 2025-05-18 No No Current