Skip to content

Checked

OTC

Lidocaine

Lidocaine is an amide local anesthetic (over-the-counter), made by 9 manufacturers.

Type
Over the counter
Drug class
Amide Local Anesthetic
Route
Topical
Manufacturers
9
+ 2 repackager labels

For industrial use: Pharmaceutical intermediate raw material for formulation compounding, lab research & pharmacy manufacturing.

Drug facts

Name
Lidocaine
Active ingredients
Lidocaine, Lidocaine Hydrochloride
Drug class
Amide Local AnestheticAntiarrhythmic
Dosage forms
Cream, Gel, Granule, Patch
Label holder
Shaanxi Shuvita Biotech Co., Ltd
FDA application
505G(a)(3)
Label updated
07/21/2026

Active ingredients

(s) Lidocaine100%

Purpose

API Raw Material for Pharmaceutical Formulation

Uses

For industrial use: Pharmaceutical intermediate raw material for formulation compounding, lab research & pharmacy manufacturing.

Directions

Industrial Storage & Handling Directions: - Warehouse bulk storage: Seal drums tightly, store at 20-25°C (68-77°F) - Avoid direct sunlight, excessive moisture & extreme temperature fluctuation - Handling: Transfer under low-dust ventilation hood only

Warnings

When handling this product

  • May cause skin & eye irritation; wear full PPE (gloves, goggles, respirator)
  • Avoid direct skin contact, inhalation of dust
  • Do not ingest; keep separate from food, drinks
  • Keep away from ignition sources, strong oxidizers
  • Restless/irritability may occur with improper exposure, especially for personnel without chemical handling training If pregnant/breastfeeding, consult industrial hygiene specialist before handling. Keep out of reach of children & untrained personnel. In case of accidental ingestion/skin absorption/eye contact, flush affected area with plenty of clean water and seek emergency medical help immediately.

Do not use

Do not ingest

When using this product

Avoid direct skin contact, inhalation of dust

Stop use and ask a doctor

When using this product keep out of eyes, ears, and mouth.

Keep out of reach of children

Keep out of reach of children.

Other information

Store at 20-25° C (68-77° F)

  • Protect from excessive moisture Shelf life: 24 months from production date when properly stored

Inactive ingredients

None

Forms and strengths

From the FDA NDC Directory · 14 product codes

Dosage formStrengthRouteNDCs
Cream5 g/100mLtopical2
Cream30 mg/gtopical1
Cream40 mg/gtopical4
Cream50 mg/gtopical2
Gel4 g/100mLtopical1
Gel50 mg/mLtopical1
Granule100 kg/100kgtopical1
Patch4 g/gtopical2

What pharmacies pay

National Average Drug Acquisition Cost (NADAC), week of 10/21/2026

All prices

Pharmacies paid about $0.362 to $0.837 per gram across 3 package codes.

NADAC is a survey of what retail pharmacies pay to buy a drug. It is not the price you pay at the counter, which depends on your insurance and the pharmacy.

Side effect reports to FDA

FDA Adverse Event Reporting System (FAERS), 57,975 reports that list lidocaine, data through 07/30/2026

Anyone can report a problem to FDA, and a report does not mean the drug caused the problem. Reports can be duplicated or incomplete, and counts depend on how widely a drug is used. Do not stop or change a medicine because of this list. Talk to your doctor or pharmacist.

Most often reported reactions

  • Drug ineffective4,341
  • Off label use4,128
  • Pain3,661
  • Fatigue3,499
  • Product adhesion issue3,452
  • Nausea3,399
  • Headache3,310
  • Product quality issue3,206
  • Sinusitis2,562
  • Dyspnea2,402

To report a side effect, use FDA MedWatch.

Manufacturers and labels

14 FDA labels · 2 from repackagers

  • Shaanxi Shuvita Biotech Co., LtdShown here505G(a)(3) · Label 07/21/2026 · NDC 87879-002Full label
  • Alexso, Inc505G(a)(3) · Label 12/09/2024 · NDC 50488-2004Full label
  • Bellus Medical, LLCM017 · Label 01/09/2026 · NDC 71888-102Full label
  • Marlex Pharmaceuticals IncM017 · Label 11/14/2025 · NDC 10135-672Full label
  • Nivagen Pharmaceuticals, Inc.M015 · Label 01/23/2025 · NDC 75834-333Full label
  • Patrin Pharma Inc.M017 · Label 11/15/2024 · NDC 39328-024Full label
  • STRATUS PHARMACEUTICALS INCM017 · Label 11/01/2024 · NDC 58980-823Full label
  • Stratus Pharmaceuticals IncM017 · Label 06/12/2025 · NDC 58980-826Full label
  • Stratus Pharmaceuticals IncM017 · Label 09/19/2024 · NDC 58980-824Full label
  • YYBA CorpM015 · Label 04/01/2026 · NDC 73581-022Full label
  • YYBA CorpM015 · Label 03/25/2026 · NDC 73581-114Full label
  • YYBA CorpM015 · Label 03/23/2026 · NDC 73581-115Full label
Repackager labels (2)
  • Advanced Rx Pharmacy of Tennessee, LLC12/31/2024
  • Preferred Pharmaceuticals Inc.09/22/2025

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Lidocaine: common questions

What is Lidocaine used for?
For industrial use: Pharmaceutical intermediate raw material for formulation compounding, lab research & pharmacy manufacturing.
Is Lidocaine a prescription drug?
No. Lidocaine is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as Lidocaine?
Yes. Other FDA-listed products with the same active ingredients include Lidocaine Hydrochloride, Lidocaine 4 Percent, IceQuake Lidocaine Analgesic.
Who makes Lidocaine?
9 manufacturers list Lidocaine with the FDA, including Shaanxi Shuvita Biotech Co., Ltd, Alexso, Inc, Bellus Medical, LLC.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 07/21/2026 · Label text is shown as published by the manufacturer. Not medical advice