FDA.reportPublic FDA data

Achelon Lidocaine Patch

Manufacturer
Achelon, Inc | Akron Coating & Adhesives
Effective date
2025-03-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:58:00

Label at a glance#

ProductAchelon Lidocaine Patch
Active ingredientLIDOCAINE
Label structure13 sections

Indications and uses

For the temporary relief of pain.

Dosage and administration

Adults and children 2 years of age or older: Apply the patch to clean dry skin 60 minutes before procedure Immediately prior to procedure, remove the center of the patch, leaving ring in place to outline treated area Follow usual needle procedure steps Remove ring after procedure Children under 2 years of age: Consult a doctor prior to use

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

Do not use

  • on raw or blistered skin
  • on the eyes
  • if alergic to lidocaine or any ingredient in the patch
  • more than 4 daily
  • with a heating pad

When using this product

OTC - WHEN USING SECTION

  • Use only as directed
  • Do not inject through any patch material

Stop use or ask a doctor if

OTC - STOP USE SECTION

If you develop a rash or skin irritation

If pregnant or breast feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children and pets

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age or older:

  • Apply the patch to clean dry skin 60 minutes before procedure
  • Immediately prior to procedure, remove the center of the patch, leaving ring in place to outline treated area
  • Follow usual needle procedure steps
  • Remove ring after procedure

Children under 2 years of age:

Consult a doctor prior to use

Other information

OTHER SAFETY INFORMATION

  • store at 68 o - 77 o F (20 o - 25 o C)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Acrylic adhesive, Polyethylene film, Mylar release liner, Polyethylene Glycol, Levulinic acid, BrijL4LQ, Isopropyl Palmitate

Achelon Lidocaine 4%, One Patch in Indivdual Pouch

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Achelon FrontAchelon Front

Drug Facts PanelDrug Facts Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1737778lidocaine 4 % Medicated PatchPSN1
1737778lidocaine 0.04 MG/MG Medicated PatchSCD1
1737778lidocaine 4 % Medicated PatchSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84209-400-01Achelon Lidocaine Patch60.81 cm2 in 1 POUCHPATCH60.811

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84209-400ACHELON LIDOCAINE PATCH (LIDOCAINE PATCH 4%) PATCH [ACHELON, INC]1Current NDC, 1 package rows20250330_31408e21-e58d-6db5-e063-6294a90aa4bc.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84209-40084209-400-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
LEVULINIC ACIDRYX5QG61EIIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S)1PEZ3NLY6IIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT

Source Document#

Source XML

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Achelon Lidocaine PatchLIDOCAINE PATCH 4%Achelon, Inc31408e21-e58d-6db5-e063-6294a90aa4bc2025-03-26WarningsExact identifier
ndc (package): 84209-400-01
ndc (product): 84209-400
ndc11 (package): 84209040001
spl id: 31408e34-cb94-3252-e063-6394a90a99a9
spl set id: 31408e21-e58d-6db5-e063-6294a90aa4bc
Achelon Lidocaine PatchLIDOCAINE PATCH 4%Achelon, Inc3143bb72-2969-d66e-e063-6294a90a46042025-03-26WarningsExact identifier
ndc (product): 84209-400

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.