Home NDC 82944-104-10 LIDOSYNC
Product NDC 82944-104
Requested package NDC 82944-104-10
11-digit product format 829440104
Labeler code 82944
Product ID 82944-104_556e3beb-c7f7-b0fc-e063-6294a90afe5b
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine 4%, Menthol 1%
Dosage form PATCH
Route TOPICAL
Labeler Ion Pharma, LLC
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-10-01
Substance LIDOCAINE; MENTHOL
Active strength 4; 1 g/1; g/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 LIDOSYNC
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE 4 g/1 MENTHOL 1 g/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 82944-104-10 LIDOSYNC 1 in 1 POUCH PATCH 1 4 82944-104-10 LIDOSYNC 10 in 1 BOX PATCH 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82944-104 LIDOSYNC (LIDOCAINE 4%, MENTHOL 1%) PATCH [ION PHARMA, LLC] 2 Current NDC, 2 package rows 20241020_11116755-885e-4cce-bc4c-d87a2baadda4.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 1 of 1 · 1 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 82944-104-10 82944010410 10 POUCH in 1 BOX (82944-104-10) / 1 PATCH in 1 POUCH 10 pouch 2023-10-01 No No Current