Home NDC 81877-725 LidoReal Patch
Product NDC 81877-725
11-digit product format 818770725
Labeler code 81877
Product ID 81877-725_241f2257-31e7-43ae-a181-243f5e97eeac
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine and Menthol
Dosage form PATCH
Route TOPICAL
Labeler FORREAL PHARMACEUTICALS LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-05-15
Substance LIDOCAINE; MENTHOL
Active strength 4; 1 mg/1; mg/1
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 LidoReal Patch
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE 4 mg/1 MENTHOL 1 mg/1
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 81877-725-15 LidoReal Patch 15 in 1 BOX PATCH 15 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81877-725 LIDOREAL PATCH (LIDOCAINE AND MENTHOL) PATCH [FORREAL PHARMACEUTICALS LLC] 2 Current NDC, 1 package rows 20240709_19f1c037-b4b8-47b0-b0f9-036691c1d307.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 Sample Exclude flag Status 81877-725-15 81877072515 15 PATCH in 1 BOX (81877-725-15) 15 patch 2024-05-15 No No Current