Drugplain

Lidocaine cream 5 g/100g

DRS Lidocaine 5% Cream · CREAM · OL PHARMA TECH LLC. (Drs. Pharmacy)

9 Recalls on Record
Plain English

Lidocaine 5% cream is a topical anesthetic that numbs the skin and is available over-the-counter to help relieve pain and itching from minor skin irritations, insect bites, and small cuts or scrapes. It works by blocking nerve signals in the area where it's applied.

Key Facts

Brand Name
Lidocaine cream
Generic Name
DRS Lidocaine 5% Cream
NDC Code (Product)
80489-949
Manufacturer
OL PHARMA TECH LLC. (Drs. Pharmacy)
Strength
5 g/100g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
M017
Drug Class
Amide Local Anesthetic [EPC]; Antiarrhythmic [EPC]
Marketing Start
11/01/2025

Recall History

9 Recalls on Record
Class II02/18/2026

HTO Nevada Inc. dba Kirkman

Stability Data Does Not Support Expiry Date.

OngoingVoluntary: Firm initiated
Class II03/15/2022

Teligent Pharma, Inc.

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

TerminatedVoluntary: Firm initiated
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated
Class II08/09/2019

Ridge Properties, LLC

Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.

TerminatedVoluntary: Firm initiated
Class II02/18/2026

HTO Nevada Inc. dba Kirkman

Stability Data Does Not Support Expiry Date.

OngoingVoluntary: Firm initiated
Class II03/15/2022

Teligent Pharma, Inc.

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

TerminatedVoluntary: Firm initiated
Class II08/09/2019

Ridge Properties, LLC

Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.

TerminatedVoluntary: Firm initiated
Class II02/10/2017

Synergy Rx

Lack of Assurance of Sterility: There are also CGMP Deviations.

TerminatedVoluntary: Firm initiated
Class II08/09/2019

Ridge Properties, LLC

Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective3,945 reports
pain3,426 reports
nausea3,405 reports
fatigue3,295 reports
headache3,150 reports
off label use2,892 reports
dyspnoea2,492 reports
diarrhoea2,260 reports
pneumonia2,105 reports
vomiting2,049 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use temporarily relieves minor pain

Dosage & Administration

Directions adults and children over 12 years: apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period children 12 years or younger: ask a doctor

Warnings

Warnings For external use only. Avoid contact with eyes. Do not use on large areas of the body or on cut, irritated or swollen skin on puncture wounds for more than one week without consulting a doctor When using this product use only as directed. Read and follow all directions and warnings on this carton. do not allow contact with the eyes do not bandage or apply local heat (such as heating pads) to the area of use Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away.

Frequently Asked Questions

What is Lidocaine cream used for?

Lidocaine 5% cream is a topical anesthetic that numbs the skin and is available over-the-counter to help relieve pain and itching from minor skin irritations, insect bites, and small cuts or scrapes. It works by blocking nerve signals in the area where it's applied.

Is Lidocaine cream a controlled substance?

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

What is the generic name for Lidocaine cream?

The generic name for Lidocaine cream is DRS Lidocaine 5% Cream. There are no other listed brand versions of DRS Lidocaine 5% Cream.

What is the NDC code for Lidocaine cream 5 g/100g?

The NDC (National Drug Code) for Lidocaine cream 5 g/100g is 80489-949, listed by OL PHARMA TECH LLC. (Drs. Pharmacy).

Product NDC

80489-949

Package NDC

80489-949-01

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

Data from openFDA · Public domain (CC0 1.0)