Drugplain

Lidocaine Patch 4 g/100g

LIDOCAINE 4% MAXIMUM STRENGTH 24 HR · PATCH · AARNA USA INC.

7 Recalls on RecordCurrently in Shortage
Plain English

Lidocaine Patch is a patch containing lidocaine 4% maximum strength 24 hr at 4 g/100g, taken topical. Manufactured by AARNA USA INC..

Key Facts

Brand Name
Lidocaine Patch
Generic Name
LIDOCAINE 4% MAXIMUM STRENGTH 24 HR
NDC Code (Product)
82568-0042
Manufacturer
AARNA USA INC.
Strength
4 g/100g
Dosage Form
PATCH
Route
TOPICAL
Marketing Status
Application #
M017
Drug Class
Amide Local Anesthetic [EPC]; Antiarrhythmic [EPC]
Marketing Start
08/18/2025

Recall History

7 Recalls on Record
Class II10/24/2024

Unexo Life Sciences Private Limited

cGMP Deviations

TerminatedVoluntary: Firm initiated
Class III04/30/2018

Teva Pharmaceuticals USA

Failed Stability Specifications

TerminatedVoluntary: Firm initiated
Class II07/14/2020

Teva Pharmaceuticals USA

Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton.

TerminatedVoluntary: Firm initiated
Class III04/20/2023

Bryant Ranch Prepack, Inc.

Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains.

OngoingVoluntary: Firm initiated
Class II04/13/2022

Mckesson Medical-Surgical Inc. Corporate Office

cGMP deviations: Temperature abuse

TerminatedVoluntary: Firm initiated
Class II04/13/2022

Mckesson Medical-Surgical Inc. Corporate Office

cGMP deviations: Temperature abuse

TerminatedVoluntary: Firm initiated
Class II04/13/2022

Mckesson Medical-Surgical Inc. Corporate Office

cGMP deviations: Temperature abuse

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective4,054 reports
off label use3,932 reports
product adhesion issue3,425 reports
pain3,345 reports
product quality issue3,163 reports
fatigue3,015 reports
nausea3,004 reports
headache2,794 reports
dyspnoea2,127 reports
pneumonia1,959 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses For the temporary relief of pain

Dosage & Administration

Directions adults/children Clean and dry affected area Peel patch off plastic liner and place patch on affected area for no more than 12 hours Wash hands after applying patch Under age 12, consult a physician before use For easier removal of the patch, apply rubbing alcohol or baby oil to adhesive edge while gently peeling. Store new and used patch away from children and pets.

Warnings

Warnings For external use only. The adhesoin properties of this patch may cause an extended period of redness. Please visit www.re-lieved.com for more information.

Frequently Asked Questions

What is Lidocaine Patch used for?

Lidocaine Patch contains LIDOCAINE 4% MAXIMUM STRENGTH 24 HR. It is a patch taken topical. Consult your doctor for specific uses.

Is Lidocaine Patch a controlled substance?

Lidocaine Patch is not classified as a controlled substance by the DEA.

What is the generic name for Lidocaine Patch?

The generic name for Lidocaine Patch is LIDOCAINE 4% MAXIMUM STRENGTH 24 HR. There are no other listed brand versions of LIDOCAINE 4% MAXIMUM STRENGTH 24 HR.

What is the NDC code for Lidocaine Patch 4 g/100g?

The NDC (National Drug Code) for Lidocaine Patch 4 g/100g is 82568-0042, listed by AARNA USA INC..

Product NDC

82568-0042

Package NDC

82568-0042-3

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)