Home NDC 83655-109 LABOFLEX Lidocaine Pain Relieving Patch
Product NDC 83655-109
11-digit product format 836550109
Labeler code 83655
Product ID 83655-109_31995f54-889e-c027-e063-6294a90a3da3
Type HUMAN OTC DRUG
Nonproprietary name lidocaine 4%
Dosage form PATCH
Route TOPICAL
Labeler Laboflex, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-01-10
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 LABOFLEX Lidocaine Pain Relieving Patch
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 83655-109-15 LABOFLEX Lidocaine Pain Relieving Patch 5 in 1 BOX PATCH 5 1 83655-109-15 LABOFLEX Lidocaine Pain Relieving Patch 1 g in 1 POUCH PATCH 1 1 83655-109-25 LABOFLEX Lidocaine Pain Relieving Patch 1 g in 1 POUCH PATCH 1 1 83655-109-25 LABOFLEX Lidocaine Pain Relieving Patch 5 in 1 BOX PATCH 5 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83655-109 LABOFLEX LIDOCAINE PAIN RELIEVING PATCH (LIDOCAINE 4%) PATCH [LABOFLEX, INC.] 1 Current NDC, 2 package rows 20250402_31995f31-c272-afdb-e063-6294a90af3f9.zip 83655-109 LABOFLEX LIDOCAINE PAIN RELIEVING PATCH (LIDOCAINE 4%) PATCH [LABOFLEX, INC.] 1 Current NDC, 2 package rows 20250112_2a3c23ed-e850-1390-e063-6294a90a637f.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 83655-109-15 83655010915 5 POUCH in 1 BOX (83655-109-15) / 1 g in 1 POUCH 5 pouch 2025-01-10 No No Current 83655-109-25 83655010925 1 g in 1 POUCH 1 g Historical