Prescription and over-the-counter medicine
Lidocaine Brand names: Xylocaine, Lidoderm, Ztlido, Xylocain, Bondlido; first approved as Xylocaine Dental
Lidocaine (Xylocaine) is a prescription and over-the-counter medicine with an FDA approval on record since 1948. FDA's NDC Directory lists it from 81 generic labelers, and pharmacies paid $0.154 per gram (Lidocaine 5% ointment) in the October 7, 2026 NADAC survey; its other strengths are brand-only, $12.31 per unit (Ztlido 1.8% topical system).
- Generic listed
- In shortage
Check it at the source: the lidocaine FDA label on DailyMed (effective May 13, 2024, Fresenius Kabi USA, LLC); the NDA 21380 record on Drugs@FDA; every lidocaine label on DailyMed.
Highlights of the record
FDA label of May 13, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageXylocaine (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
Forms and strengths
- 36 mg
- 50 mg
- 200 mg
- 700 mg
- 4 mg/ml
- 5 mg/ml
- 5 g/100g
- 8 mg/ml
- 10 mg/ml
- 15 mg/ml
- 20 mg/ml
- 35 mg/ml
Injection (solution); ointment; patch; solution; jelly.
On the market
- Earliest approval on file
- November 19, 1948 Xylocaine Dental, Dentsply Pharm; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 120 first June 30, 1971; 68 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 88 of which 81 under generic applications, 10 under brand applications, repackagers included; 371 more under the over-the-counter monograph, without an application
- Last listed patent
- September 28, 2035 Zingo system; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.154 per gram Lidocaine 5% ointment
- Shortage (FDA)
- 15 of 51 presentations limited or unavailable updated October 6, 2026
- Recalls by its makers (FDA)
- 39 since 2012 10 Class I among all firms' recalls; latest August 31, 2026; 24 more by firms not listed as its makers
- FAERS reports
- 71,853 through July 30, 2026
What is lidocaine used for?
From the label: indications and usageXylocaine (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 textbooks are observed.
Conditions named in the indications of lidocaine's FDA labels, with every medicine labeled for each:
From other lidocaine labelsPain: Indications and usage For the temporary relief of pain Peel patch off plastic liner and place lpatch on affected area for no more than 12 hours
FDA pharmacologic class: Amide Local Anesthetic and Antiarrhythmic.
Source: FDA drug label (Xylocaine MPF), Fresenius Kabi USA, LLC, effective May 13, 2024 (SPL set d5e0d06f-ba1e-44d4-aa89-39d6c146dc23), via openFDA; the full label on DailyMed
What does the patient leaflet for lidocaine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while using BONDLIDO?Avoid contact of your hands and fingers with your eyes while handling BONDLIDO. Contact of BONDLIDO with your eyes can cause severe eye irritation. Wash your hands right away after handling BONDLIDO. If the medicine in BONDLIDO comes in contact with your eye, wash out your eye with water or saline right away. Protect the eye (for example with eye glasses or eye wear) until the numbness goes away.
From the patient leaflet: How should I store BONDLIDO?Store BONDLIDO at room temperature between 68°F to 77°F (20°C to 25°C). Do not store BONDLIDO outside the sealed pouch. Protect BONDLIDO from light. Each BONDLIDO topical system comes in a child-resistant pouch. Keep BONDLIDO and all medicines out of the reach of children, pets, and others.
Source: FDA drug label (BONDLIDO), MEDRx USA, Inc., effective October 6, 2025 (SPL set 17e69028-d2c2-4080-8090-cb0cab570196), via openFDA; the full label on DailyMed
Is there a generic for lidocaine (Xylocaine)?
The FDA approved the first generic lidocaine on June 30, 1971. 120 generic applications are approved; 68 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists lidocaine from 81 labelers under a generic (ANDA) application and from 10 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Xylocaine injection; a patent listed only for Zingo system runs to September 28, 2035. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1948 earliest approval on file
- 1971 first generic approved
- 2035 last listed patent
- 2012 to now in shortage
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for lidocaine (Xylocaine)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.154 per gram (Lidocaine 5% ointment), down 8% from $0.167 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Lidocaine 5% ointment (generic)
- Ztlido 1.8% topical system (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Anlido 4% patch | Generic | $1.10 per patch | n/a | +14% |
| Burn relief 0.5% spray | Generic | $0.0278 per gram | n/a | +1% |
| Dermacinrx lidocan 5% patch | Generic | $2.00 per patch | n/a | n/a |
| Ft pain relief(lido) 4% patch | Generic | $1.10 per patch | n/a | +15% |
| Glydo 2% jelly syringe | Generic | $0.707 per mL | n/a | +3% |
| Gnp lidocaine HCl 4% cream | Generic | $0.0521 per gram | n/a | -0.6% |
| Gnp lidocaine pain rlf 4% ptch | Generic | $1.10 per unit | n/a | n/a |
| Hemorrhoidal relief 5% cream | Generic | $0.399 per gram | n/a | -12% |
| Lidocaine 2% viscous solution | Generic | $0.0825 per mL | n/a | -12% |
| Lidocaine 3% cream | Generic | $0.462 per gram | n/a | -31% |
| Lidocaine 4% cream | Generic | $0.490 per gram | n/a | +5% |
| Lidocaine 4% patch | Generic | $1.10 per patch | n/a | +15% |
| Lidocaine 5% ointment | Generic | $0.154 per gram | n/a | -8% |
| Lidocaine 5% patch | Generic | $2.00 per patch | n/a | -2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is lidocaine in shortage?
The FDA Drug Shortage Database lists 15 of 51 lidocaine presentations as limited or unavailable (updated October 6, 2026); the first entry was posted on February 22, 2012. 34 more presentations are on the list as available.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Lidocaine Hydochloride, Injection, 50 mg/5 mL (NDC 83634-653-05) | Anthea Pharma | Current | October 5, 2026 |
| Lidocaine Hydrochloride And Dextrose, Injection, 4 mg/1 mL (NDC 0338-0409-03) | Baxter Healthcare | Current | October 2, 2026 |
| Lidocaine Hydrochloride And Dextrose, Injection, 8 mg/1 mL (NDC 0338-0411-02) | Baxter Healthcare | Current | October 2, 2026 |
| Lidocaine Hydrochloride In Plastic Container, Injection, 1,000 mg/50 mL (2%; 20 mg/mL) (NDC 0409-4277-02) | Hospira, Inc., a Pfizer Company | Current | September 22, 2026 |
| Lidocaine Hydrochloride In Plastic Container, Injection, 10 mg/1 mL (NDC 63323-201-02) | Fresenius Kabi USA, LLC | Current | October 6, 2026 |
| Lidocaine Hydrochloride In Plastic Container, Injection, 200 mg/20 mL (1%; 10 mg/mL) (NDC 0409-4276-01) | Hospira, Inc., a Pfizer Company | Current | September 22, 2026 |
| Lidocaine Hydrochloride In Plastic Container, Injection, 250 mg/50 mL (0.5%; 5 mg/mL) (NDC 0409-4275-01) | Hospira, Inc., a Pfizer Company | Current | September 22, 2026 |
| Lidocaine Hydrochloride In Plastic Container, Injection, 400 mg/20 mL (2%; 20 mg/mL) (NDC 0409-4277-01) | Hospira, Inc., a Pfizer Company | Current | September 22, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has lidocaine been recalled?
The FDA's Enforcement Report lists 63 recalls naming lidocaine since 2012: 10 Class I (the most serious), 48 Class II, 5 Class III; 20 still ongoing. 24 of them are by firms that FDA's NDC Directory does not list as a maker of lidocaine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 31, 2026 | Class II | SUN PHARMA /TARO | Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25°C,60%RH). |
| July 16, 2026 | Class II | Fresenius Kabi USA, LLC | Presence of Particulate Matter: Hair was found in products |
| June 8, 2026 | Class II | Asclemed USA Inc. not a listed maker | Lack of Assurance of Sterility |
| May 18, 2026 | Class III | Eugia US LLC | Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan |
| May 12, 2026 | Class II | Spectra Medical Devices, Llc | Lack of Assurance of Sterility |
| April 2, 2026 | Class II | Huons Co., Ltd. | Lack of Assurance of Sterility |
| June 2, 2025 | Class II | Tailstorm Health INC not a listed maker | Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process. |
| October 24, 2024 | Class II | Unexo Life Sciences Private Limited not a listed maker | cGMP Deviations |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the lidocaine label say about other medicines?
The lidocaine label names 10 other medicines in its interaction, contraindication or warning sections. The labels of 43 other medicines name lidocaine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amiodarone | drug interactions | When lidocaine is administered with other antiarrhythmic drugs such as amiodarone, phenytoin, procainamide, propranolol or quinidine, the cardiac effects may be additive or antagonistic and toxic effects may be additive. |
| Cimetidine | drug interactions | Monitor toxicity when coadministering lidocaine with cimetidine. |
| Epinephrine | drug interactions | Clinically Significant Drug Interactions The administration of local anesthetic solutions containing epinephrine or norepinephrine to patients receiving monoamine oxidase inhibitors or tricyclic antidepressants may produce severe, prolonged hypertension. |
| Fluvoxamine | drug interactions | Concomitant use of lidocaine at steady-state concentrations of the CYP1A2 inhibitor fluvoxamine increases intravenous lidocaine plasma AUC and C max by 71% and 22%, and decreases MEGX AUC and C max by 54% and 65%. |
| Methylene blue | warnings | A more severe clinical presentation may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen. |
| Phenytoin | drug interactions | When lidocaine is administered with other antiarrhythmic drugs such as amiodarone, phenytoin, procainamide, propranolol or quinidine, the cardiac effects may be additive or antagonistic and toxic effects may be additive. |
| Procainamide | drug interactions | When lidocaine is administered with other antiarrhythmic drugs such as amiodarone, phenytoin, procainamide, propranolol or quinidine, the cardiac effects may be additive or antagonistic and toxic effects may be additive. |
| Propofol | drug interactions | Concomitant use of lidocaine with propofol, a hypnotic agent and CYP3A4 inhibitor, may increase lidocaine plasma levels by reducing lidocaine clearance. |
| Propranolol | drug interactions | When lidocaine is administered with other antiarrhythmic drugs such as amiodarone, phenytoin, procainamide, propranolol or quinidine, the cardiac effects may be additive or antagonistic and toxic effects may be additive. |
| Quinidine | drug interactions | When lidocaine is administered with other antiarrhythmic drugs such as amiodarone, phenytoin, procainamide, propranolol or quinidine, the cardiac effects may be additive or antagonistic and toxic effects may be additive. |
Other labels that name lidocaine
- Acetaminophen
- Atazanavir
- Botulinum toxin type a
- Ceftriaxone
- Cobicistat, elvitegravir, emtricitabine and tenofovir alafenamide
- Cobicistat, elvitegravir, emtricitabine and tenofovir disoproxil
- Darunavir
- Disopyramide
- Ertapenem
- Etravirine
- Fosamprenavir
- Metyrosine
- Nevirapine
- Phentolamine
- Propafenone
- Raloxifene
- Ritonavir
- Sodium bicarbonate
- Succinylcholine
Source: FDA drug label (Xylocaine MPF), Fresenius Kabi USA, LLC, effective May 13, 2024 (SPL set d5e0d06f-ba1e-44d4-aa89-39d6c146dc23), via openFDA; the full label on DailyMed
What do FAERS reports show for lidocaine?
The FDA Adverse Event Reporting System holds 71,853 reports that list lidocaine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6,533 are coded as a death and 23,748 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as lidocaine?
13 other medicines are given the same way (topical) and in the same FDA class as lidocaine or labeled mainly for the same use (pain), the same class first. Pain lists all 80 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (topical) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Menthol | Pain | none listed | $0.0557 per mL 4% gel | No current entry |
| Diclofenac | Pain | 103 labelers | $0.0813 per gram 1% gel | A presentation being discontinued |
| Bacitracin and neomycin and polymyxin b | Pain | none listed | $0.111 per gram Triple antibiotic ointment | No current entry |
| Menthol and methyl salicylate | Pain | none listed | $0.0365 per gram 15%-10% cream | No current entry |
| Capsaicin | Pain | none listed | $0.207 per gram 0.1% cream | No current entry |
| Benzocaine | Pain | none listed | n/a | No current entry |
| Witch hazel | Pain | none listed | $0.0435 per unit 50% pad | No current entry |
| Camphor | Pain | none listed | $0.048 per mL Camphor spirit | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does lidocaine compare with medicines for the same use?
8 side-by-side pages set lidocaine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Other amide local anesthetics
- the pharmacologic class, with prices and generics
- Lidocaine side effects
- the label's list beside FAERS reports
- Lidocaine shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other