FDA.reportPublic FDA data

Lidocaine Patch 4%

Manufacturer
Medcore LLC
Effective date
2025-04-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:01:11

Label at a glance#

ProductLidocaine Patch 4%
Active ingredientLIDOCAINE
Label structure9 sections

Indications and uses

For temporary relief of pain

Dosage and administration

Adult and children 12 years of age and over : clean and dry affected area apply 1 patch at a time to affected area,not more than 3 to 4 times daily remove patch from the skin after at most 8-hour application Children under 12 years of age : consult a doctor

Storage and handling

Store at room temperature 15°–30°C (59°–86°F) Avoid storing product in direct sunlight and protect product from excessive moisture.

Label contents#

Full prescribing information#

​

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pain

Warnings

WARNINGS SECTION

(​For external use only)

Do not use

OTC - DO NOT USE SECTION

  • more than 1 patch at a time
  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of this product

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • condition worsen
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

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

Adult and children 12 years of age and over:

  • clean and dry affected area
  • apply 1 patch at a time to affected area,not more than 3 to 4 times daily
  • remove patch from the skin after at most 8-hour application

Children under 12 years of age: consult a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin, edetate disodium, tartaric acid. povidone K90. polysorbate80, propylene glycol, carboxymethylcellulose sodium, kaolin, carbomer, sodium polyacrylate,purified water. phenoxyethanol.

Other information

STORAGE AND HANDLING SECTION

Store at room temperature 15°–30°C (59°–86°F)
Avoid storing product in direct sunlight and protect product from excessive moisture.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 82461-416-30

Medcore LLC

Lidocaine Patch 4%

Pain Relieving Hydrogel Technology

Contains:

30 Patches

Manufactured for: Medcore LLC 3048 Valley Rd Basking Ridge, NJ 07920

Store in a dry, cool place for Comments or Questions, call 908-280-2269

LidocaineLidocaine

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82461-416-30Lidocaine Patch 4%6 in 1 BOXPATCH61
82461-416-30Lidocaine Patch 4%5 g in 1 POUCHPATCH51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82461-416LIDOCAINE PATCH 4% (LIDOCAINE 4%) PATCH [MEDCORE LLC]1Current NDC, 2 package rows20250519_b961906c-fe66-466b-af2c-072781fa098b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82461-416-30EA - Each82461-416dda3a8e4-8997-4d5b-9458-cb37466dfb4212025-06-13

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82461-41682461-416-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
KAOLIN24H4NWX5COIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
TARTARIC ACIDW4888I119HIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT
METHYLPARABENA2I8C7HI9TIACT

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine Patch 4%LIDOCAINE 4%Medcore LLCb961906c-fe66-466b-af2c-072781fa098b2025-04-28WarningsExact identifier
ndc (package): 82461-416-30
ndc (product): 82461-416
ndc11 (package): 82461041630
spl id: bf38c2df-2b08-430e-8272-c9975d2e8e38
spl set id: b961906c-fe66-466b-af2c-072781fa098b

Reported adverse events (FAERS/openFDA)#

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