Home NDC 85231-100 LIDOGUARD
Product NDC 85231-100
11-digit product format 852310100
Labeler code 85231
Product ID 85231-100_4dd75a34-1b69-c67d-e063-6394a90a1007
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine 4%
Dosage form PATCH
Route TOPICAL
Labeler ViolaCare, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-06-01
Substance LIDOCAINE
Active strength 4 g/100g
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 LIDOGUARD
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE 4 g/100g
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1737778 Internal RxNorm lookup 2717286 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 85231-100-15 LIDOGUARD 1 in 1 POUCH PATCH 1 3 85231-100-15 LIDOGUARD 15 in 1 BOX PATCH 15 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85231-100 LIDOGUARD (LIDOCAINE 4%) PATCH [VIOLACARE, INC.] 1 Current NDC, 2 package rows 20250515_d8b021b6-cf71-4f7e-9d27-92d0982bd34f.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 85231-100-15 85231010015 15 POUCH in 1 BOX (85231-100-15) / 1 PATCH in 1 POUCH / 4 g in 1 PATCH 15 pouch 2025-05-01 No No Current