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Prescription medicine · generic available

Lidocaine

Also listed by the FDA as: lidocaine hydrochloride · lidocaine · lidocaine hydrochloride anhydrous

Drug class: Amide Local Anesthetic, Antiarrhythmic

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Quick answers

What is Lidocaine used for?
The FDA-approved label (Xylocaine, Sportpharm LLC, February 3, 2026) says: “Xylocaine (lidocaine HCl) Injections are indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Lidocaine have a boxed warning?
The label we quote has no boxed warning, but 14 of 275 FDA labels for this medicine do. Check the label of your own product.
Is there a shortage of Lidocaine?
The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 21, 2026). Ask your pharmacist about alternatives.
Has Lidocaine been recalled?
FDA enforcement reports list 31 recalls of products of this medicine; the newest started August 31, 2026 (Class II). A recall usually concerns specific lots, not every product.
Who makes Lidocaine?
84 companies list prescription products of Lidocaine in the FDA NDC Directory, including HF Acquisition Co LLC, DBA HealthFirst, Eugia US LLC and Medical Purchasing Solutions, LLC.

What Lidocaine is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Xylocaine (lidocaine HCl) Injections are indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard …

— FDA label: Xylocaine, Sportpharm LLC, effective February 3, 2026. Read the full label on DailyMed →

The FDA has 275 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

14 of 275 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsInjection, solution · Ointment · Patch · Solution · Jelly · Injection · System · Gel
RouteInfiltration · Topical · Perineural · Epidural · Intracaudal · Intravenous
Prescription products369 in the FDA NDC Directory
Brand namesXylocaine Mpf, Xylocaine, Lidocaine Viscous, Lidocaine Hydrochloride and Dextrose, Bondlido, Lidocan III, Lidocan, Lidox 5 Patch, Lidocan V, Lidoderm, Lidocan Vi, Lidocan Vii

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Lidocaine, by strength and form
Strength and formGeneric or brandPharmacies pay
lidocaine 36 mg
patch
Brand: Ztlido $12.31 per patch
lidocaine 5%
ointment
Generic $0.1411–$0.1641 per gram
18 packages, lowest to highest
lidocaine 5%
patch
Generic $1.99 per patch
lidocaine 700 mg
patch
Generic $1.99 per patch
lidocaine hydrochloride 10 mg/mL
injection, solution
Generic $0.0542–$0.8000 per mL
25 packages, lowest to highest
lidocaine hydrochloride 20 mg/mL
injection, solution
Generic $0.0714–$0.3487 per mL
11 packages, lowest to highest
lidocaine hydrochloride 20 mg/mL
jelly
Generic $0.7040–$3.20 per mL
4 packages, lowest to highest
lidocaine hydrochloride 20 mg/mL
solution
Generic $0.0827 per mL
lidocaine hydrochloride 40 mg/mL
solution
Generic $0.2324 per mL
lidocaine hydrochloride anhydrous 10 mg/mL
injection, solution
Generic $0.0542–$0.8000 per mL
8 packages, lowest to highest
lidocaine hydrochloride anhydrous 20 mg/mL
injection, solution
Generic $0.0714–$0.3487 per mL
6 packages, lowest to highest
lidocaine hydrochloride anhydrous 20 mg/mL
jelly
Generic $0.5136–$0.9010 per mL
2 packages, lowest to highest
lidocaine hydrochloride anhydrous 20 mg/mL
solution
Generic $0.0827 per mL
lidocaine hydrochloride anhydrous 40 mg/mL
solution
Generic $0.2324 per mL

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA006488
XYLOCAINE, XYLOCAINE W/ EPINEPHRINE
Fresenius Kabi USANovember 19, 1948 75, latest October 30, 2024
2024: Labeling · 2018: Labeling · 2017: Manufacturing (CMC)
NDA017584
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
Fresenius Kabi USAMarch 26, 1976 26, latest August 17, 2026
2026: Labeling · 1996: Labeling · 1995: Manufacturing (CMC)
NDA018461
LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER
Baxter HlthcareApril 22, 1981 45, latest February 7, 2017
2017: Labeling · 2015: Manufacturing (CMC) · 2012: Labeling
NDA020612
LIDODERM
Teikoku Pharma USAMarch 19, 1999 8, latest November 2, 2018
2018: Labeling · 2016: Manufacturing (CMC) · 2015: Labeling
NDA022221
AKTEN
Thea PharmaOctober 7, 2008 4, latest November 21, 2025
2025: Labeling · 2022: Labeling · 2014: Labeling
NDA207962
ZTLIDO
Scilex PharmsFebruary 28, 2018 2, latest April 8, 2021
2021: Efficacy · 2018: Labeling
NDA215029
BONDLIDO
Medrx USASeptember 24, 2025 —

Generic approvals (61)

Showing the 40 earliest of 61.

Shortage status

Current shortage · updated October 21, 2026 · first posted February 22, 2012

ProductLidocaine Hydrochloride, Injection, 250 mg/50 mL (0.5%; 5 mg/mL) (NDC 0409-4278-01)
AvailabilityAvailable
CompanyHospira, Inc., a Pfizer Company

Ask your pharmacist whether your product is affected and what the options are.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. August 31, 2026 · Class II · Ongoing · D-0848-2026

    Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).

    Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, L6T1C, Canada, Dist By: Taro Pharmaceuticals U.S.A. Inc. Hawthorne NY 70532 NDC: 51672-3008-5 — SUN PHARMA /TARO

  2. July 16, 2026 · Class II · Ongoing · D-0726-2026

    Presence of Particulate Matter: Hair was found in products

    Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-208-05; NDC Vial: 63323-208-01 — Fresenius Kabi USA, LLC

  3. July 16, 2026 · Class II · Ongoing · D-0728-2026

    Presence of Particulate Matter: Hair was found in products

    Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-27; NDC Vial: 63323-485-01 — Fresenius Kabi USA, LLC

  4. July 16, 2026 · Class II · Ongoing · D-0729-2026

    Presence of Particulate Matter: Hair was found in products

    Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-57; NDC Vial: 63323-485-03 — Fresenius Kabi USA, LLC

  5. July 15, 2026 · Class III · Ongoing · D-0713-2026

    Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan

    Lidolog Kit, Kit Contains: Lidocaine HCl Injection, USP, 2% (2mL) vial, 1 Dose, Single use Only, Rx Only, Distributed by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-760-01. — Asclemed USA Inc.

  6. June 8, 2026 · Class II · Ongoing · D-0659-2026

    Lack of Assurance of Sterility

    Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 85766-187-01. — Asclemed USA Inc.

  7. May 18, 2026 · Class III · Ongoing · D-0552-2026

    Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan

    Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520. NDC: 55150-164-02 — Eugia US LLC

  8. May 12, 2026 · Class II · Ongoing · D-0554-2026

    Lack of Assurance of Sterility

    Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1. — Spectra Medical Devices, Llc

  9. April 2, 2026 · Class II · Ongoing · D-0529-2026

    Lack of Assurance of Sterility

    Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials, Rx only, Manufactured by: Huons Co, Ltd, Chungcheongbuk-do, Korea NDC 73293-0001-1 (vial), NDC 73293-0001-2 (10 count carton); Distributed by: — Huons Co., Ltd.

  10. April 2, 2026 · Class II · Ongoing · D-0532-2026

    Lack of Assurance of Sterility

    Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials, Rx only, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 73293-0003-1 (vial), NDC 73293-0003- — Huons Co., Ltd.

  11. April 20, 2023 · Class III · Ongoing · D-0556-2023

    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.

    Lidocaine Patch 5%, 1 patch (63629-8755-20) packaged in 30-count patches per carton (63629-8755-1), Rx only, each patch contains: 700 mg (50mg per gram adhesive) in an aqueous base, Manufactured by: Actavis Laboratories — Bryant Ranch Prepack, Inc.

  12. April 13, 2022 · Class II · Terminated · D-1068-2022

    cGMP deviations: Temperature abuse

    Lidocaine Patch 5%, 30-count box, Rx only, MFG: Teva Pharma USA, NDC 0591-3525-30 — Mckesson Medical-Surgical Inc. Corporate Office

  13. April 13, 2022 · Class II · Terminated · D-1043-2022

    cGMP deviations: Temperature abuse

    Lidocaine Patch 5%, 30-count carton, Rx only, MFG: Qualitest Products, NDC 0603-1880-16 — Mckesson Medical-Surgical Inc. Corporate Office

  14. April 13, 2022 · Class II · Terminated · D-1052-2022

    cGMP deviations: Temperature abuse

    Xylocaine + Epinephrine, multi dose vial 1%, packaged in a) 20 mL, 25-count box (NDC 63323-482-27) b) 50 mL, 25-count box (NDC 63323-482-57), Rx only, MFG: Fresenius Kabi USA LLC — Mckesson Medical-Surgical Inc. Corporate Office

  15. April 13, 2022 · Class II · Terminated · D-1053-2022

    cGMP deviations: Temperature abuse

    Xylocaine + Epinephrine, multi dose vial 2%, 20 mL, 25 count box, Rx only, MFG: Fresenius Kabi USA LLC, NDC 63323-483-27 — Mckesson Medical-Surgical Inc. Corporate Office

  16. November 30, 2021 · Class II · Ongoing · D-0296-2022

    Superpotent Drug: Minimally superpotent

    Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging, — Teligent Pharma, Inc.

  17. November 30, 2021 · Class I · Ongoing · D-0295-2022

    Superpotent Drug

    Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging, — Teligent Pharma, Inc.

  18. October 12, 2021 · Class II · Terminated · D-0279-2022

    CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.

    Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Manufactured by: Teligent Pharma Inc., Buena, NJ 06310, Distributed by: McKesson Corporation dba Sky Packaging, 497 Southridge Blv — Teligent Pharma, Inc.

  19. June 25, 2021 · Class II · Terminated · D-0651-2021

    Low out of specification results for epinephrine assay.

    Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL, (10 mg/mL), 30 mL Single Dose Vial, 25 Vials per Tray, Rx only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047. — Fresenius Kabi USA LLC

  20. May 3, 2021 · Class I · Terminated · D-0627-2021

    Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP

    1% Lidocaine HCl Injection, USP, 300 mg/30 mL (10 mg/mL), 30 mL Single-dose vial (NDC 0409-4279-16), packaged in 25 vials per tray (NDC 0409-4279-02), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. — PFIZER, INC

  21. July 14, 2020 · Class II · Terminated · D-1492-2020

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

    Lidocaine Patch 5%, packaged in 30-count cartons, Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-3525-30 — Teva Pharmaceuticals USA

  22. November 11, 2019 · Class II · Terminated · D-0573-2020

    Presence of Foreign Substance: Foreign material found inside the vial.

    Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, packaged in 10 x 5 mL Single Dose Vials per carton, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ — AuroMedics Pharma LLC

  23. March 28, 2019 · Class I · Terminated · D-1248-2019

    Presence of Particulate Matter: One vial was found to contain a hair.

    Lidocaine HCl Injection, USP 1 % 50 mg/5 mL (10 mg/mL), 5mL vial, Rx only, Mrd. in India for: AuroMedics Pharna LLC. E Windsor, NJ 08520 NDC 55150-162-05 — Aurobindo Pharma USA Inc.

  24. April 30, 2018 · Class III · Terminated · D-0857-2018

    Failed Stability Specifications

    Lidocaine Patch 5% (700 mg) ,(NDC 0591-3525-11), 30 envelopes containing 1 patch each/ 30 Patches/Carton (NDC 0591-3525-30) — Teva Pharmaceuticals USA

  25. August 25, 2015 · Class II · Ongoing · D-1815-2015

    Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded in the neck of glass vials.

    1% Lidocaine HCl Injection, USP, 10 mg/mL, 30 mL Vial, Single-dose Preservative Free, Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-4279-02 — Hospira, Inc.

Showing the newest 25 of 31.

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)1009462, 1010033, 1010035, 1010671, 1010673, 1010688, 1010692, 1010739, 1010745, 1010749 … (+10)
SPL set ID of the quoted label94155012-b1fc-430a-a1f5-30c21f4a3f80
FDA labels (SPL)275
FDA applicationsNDA006488, NDA017584, NDA018461, NDA020612, NDA022221, NDA207962, NDA215029, 61 ANDA
Active ingredients (FDA)LIDOCAINE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Xylocaine, Sportpharm LLC, effective February 3, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

Report an error → · Information for medicine makers