Home NDC 84209-400 Achelon Lidocaine Patch
Product NDC 84209-400
11-digit product format 842090400
Labeler code 84209
Product ID 84209-400_31408e34-cb94-3252-e063-6394a90a99a9
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine Patch 4%
Dosage form PATCH
Route TOPICAL
Labeler Achelon, Inc
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-03-26
Substance LIDOCAINE
Active strength 7.54 mg/60.81cm2
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 Achelon Lidocaine Patch
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE 7.54 mg/60.81cm2
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 84209-400-01 Achelon Lidocaine Patch 60.81 cm2 in 1 POUCH PATCH 60.81 1 84209-400-03 Achelon Lidocaine Patch 3 in 1 BOX PATCH 3 1 84209-400-03 Achelon Lidocaine Patch 20.27 cm2 in 1 POUCH PATCH 20.27 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84209-400 ACHELON LIDOCAINE PATCH (LIDOCAINE PATCH 4%) PATCH [ACHELON, INC] 1 Current NDC, 1 package rows 20250330_31408e21-e58d-6db5-e063-6294a90aa4bc.zip 84209-400 ACHELON LIDOCAINE PATCH (LIDOCAINE PATCH 4%) PATCH [ACHELON, INC] 1 Current NDC, 2 package rows 20250330_3143bb72-2969-d66e-e063-6294a90a4604.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 84209-400-01 84209040001 60.81 cm2 in 1 POUCH (84209-400-01) 60.81 cm2 2025-03-26 No No Current 84209-400-03 84209040003 3 POUCH in 1 BOX (84209-400-03) / 20.27 cm2 in 1 POUCH 3 pouch 2025-03-26 No No Current