Prescription and over-the-counter medicine
Epinephrine and lidocaine Brand names: Xylocaine, Xylocaine-Mpf, Flavalta, Lignospan
Epinephrine and 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 17 generic labelers, and pharmacies paid $0.139 per mL (Lidocaine 1%-epi 1:100,000) in the October 7, 2026 NADAC survey.
- Generic listed
- In shortage
Check it at the source: the epinephrine and lidocaine FDA label on DailyMed (effective August 27, 2026, REMEDYREPACK INC.); the NDA 6488 record on Drugs@FDA; every epinephrine and lidocaine label on DailyMed.
Highlights of the record
FDA label of August 27, 2026; 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
- 0.005 mg/ml / 20 mg/ml
- 0.01 mg/ml / 10 mg/ml
- 5 mg/ml / 0.005 mg/ml
- 5 mg/ml
- 10 mg/ml
- 10 mg/ml / 0.01 mg/ml
- 10 mg/ml / 0.005 mg/ml
- 15 mg/ml / 0.005 mg/ml
- 15 mg/ml
- 20 mg/ml / 0.01 mg/ml
- 20 mg/ml
- 20 mg/ml / 0.02 mg/ml
Injection (solution); injection.
On the market
- Earliest approval on file
- November 19, 1948 Xylocaine W/ Epinephrine, Fresenius Kabi Usa; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 27 first February 23, 1972; 9 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 21 of which 17 under generic applications, 9 under brand applications, repackagers included; 3 more under the over-the-counter monograph, without an application
Supply and safety
- Pharmacy cost (NADAC)
- $0.139 per mL Lidocaine 1%-epi 1:100,000
- Shortage (FDA)
- 8 of 10 presentations limited or unavailable updated September 22, 2026
- Recalls by its makers (FDA)
- 9 since 2013 0 Class I among all firms' recalls; latest October 31, 2025; 2 more by firms not listed as its makers
- FAERS reports
- 53,158 through July 30, 2026
What is epinephrine and 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 epinephrine and lidocaine's FDA labels, with every medicine labeled for each:
From other epinephrine and lidocaine labelsPain: Temporarily relieves local discomfort or pain and swelling or burning associated with anorectal disorders.
FDA pharmacologic class: Amide Local Anesthetic, Antiarrhythmic, Catecholamine, alpha-Adrenergic Agonist and beta-Adrenergic Agonist.
Source: FDA drug label (Xylocaine), NDA006488 (Fresenius Kabi Usa), as published by REMEDYREPACK INC., effective August 27, 2026 (SPL set 1414bcfc-1543-4ad4-83bd-4fc444a02e92), via openFDA; the full label on DailyMed
Is there a generic for epinephrine and lidocaine (Xylocaine)?
The FDA approved the first generic epinephrine and lidocaine on February 23, 1972. 27 generic applications are approved; 9 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 epinephrine and lidocaine from 17 labelers under a generic (ANDA) application and from 9 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1948 earliest approval on file
- 1972 first generic approved
- 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 epinephrine and lidocaine (Xylocaine)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.139 per mL (Lidocaine 1%-epi 1:100,000). 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 1%-epi 1:100,000 (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Lidocaine 1%-epi 1:100,000 | Generic | $0.139 per mL | n/a | n/a |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is epinephrine and lidocaine in shortage?
The FDA Drug Shortage Database lists 8 of 10 epinephrine and lidocaine presentations as limited or unavailable (updated September 22, 2026); the first entry was posted on February 22, 2012. 2 more presentations are on the list as available.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Lidocaine Hydrochloride And Epinephrine, Injection, 1 g/50 mL (2%; 1:100,000) (NDC 0409-3182-03) | Hospira, Inc., a Pfizer Company | Current | September 22, 2026 |
| Lidocaine Hydrochloride And Epinephrine, Injection, 200 mg/20 mL (1%; 1:100,000) (NDC 0409-3178-01) | Hospira, Inc., a Pfizer Company | Current | September 22, 2026 |
| Lidocaine Hydrochloride And Epinephrine, Injection, 250 mg/50 mL (0.5%; 1:200,000) (NDC 0409-3177-01) | Hospira, Inc., a Pfizer Company | Current | September 22, 2026 |
| Lidocaine Hydrochloride And Epinephrine, Injection, 300 mg/30 mL (1%; 1:100,000) (NDC 0409-3178-02) | Hospira, Inc., a Pfizer Company | Current | September 22, 2026 |
| Lidocaine Hydrochloride And Epinephrine, Injection, 400 mg/20 mL (2%; 1:100,000) (NDC 0409-3182-01) | Hospira, Inc., a Pfizer Company | Current | September 22, 2026 |
| Lidocaine Hydrochloride And Epinephrine, Injection, 400 mg/20 mL (2%; 1:200,000) (NDC 0409-3183-01) | Hospira, Inc., a Pfizer Company | Current | September 22, 2026 |
| Lidocaine Hydrochloride And Epinephrine, Injection, 450 mg/30 mL (1.5%; 1:200,000) (NDC 0409-3181-01) | Hospira, Inc., a Pfizer Company | Current | September 22, 2026 |
| Lidocaine Hydrochloride And Epinephrine, Injection, 500 mg/50 mL (1%; 1:100,000) (NDC 0409-3178-03) | Hospira, Inc., a Pfizer Company | Current | September 22, 2026 |
Every epinephrine and lidocaine presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has epinephrine and lidocaine been recalled?
The FDA's Enforcement Report lists 11 recalls naming epinephrine and lidocaine since 2013: 0 Class I (the most serious), 10 Class II, 1 Class III; 4 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of epinephrine and 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 |
|---|---|---|---|
| February 2, 2026 | Class II | Pro Numb Tattoo Numbing Spray LLC not a listed maker | cGMP deviations |
| October 31, 2025 | Class II | Novocol Pharmaceutical of Canada, Inc. | Defective container: cracked/broken cartridges |
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
| December 6, 2021 | Class II | Edge Pharma, LLC | Lack of Assurance of Sterility |
| June 25, 2021 | Class II | Fresenius Kabi USA LLC | Low out of specification results for epinephrine assay. |
| December 22, 2020 | Class III | Edge Pharma, LLC | Labeling: Incorrect or Missing Lot and/or Exp Date |
| August 14, 2013 | Class II | Novocol Pharmaceutical of Canada | Subpotent Drug; Two lots of Lidocaine 2% with Epinephrine 1:100,000 Injectable, distributed under the names: Octocaine 100, and 2% Xylocaine Dental, may be … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the epinephrine and lidocaine label say about other medicines?
The epinephrine and lidocaine label names 24 other medicines in its interaction, contraindication or warning sections. 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 |
|---|---|---|
| Acetaminophen | drug interactions | Class: Other drugs; Examples: acetaminophen, metoclopramide, quinine, sulfasalazine |
| Benzocaine | drug interactions | Class: Local anesthetics; Examples: articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine |
| Bupivacaine | drug interactions | Class: Local anesthetics; Examples: articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine |
| Chloroquine | drug interactions | Class: Antimalarials; Examples: chloroquine, primaquine |
| Cyclophosphamide | drug interactions | Class: Antineoplastic agents; Examples: cyclophosphamide, flutamide, hydroxyurea, isofamide, rasburicase |
| Dapsone | drug interactions | Class: Antibiotics; Examples: dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides |
| Flutamide | drug interactions | Class: Antineoplastic agents; Examples: cyclophosphamide, flutamide, hydroxyurea, isofamide, rasburicase |
| Hydroxyurea | drug interactions | Class: Antineoplastic agents; Examples: cyclophosphamide, flutamide, hydroxyurea, isofamide, rasburicase |
| Mepivacaine | drug interactions | Class: Local anesthetics; Examples: articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine |
| Methylene blue | warnings | A more severe clinical presentation may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen. |
| Metoclopramide | drug interactions | Class: Other drugs; Examples: acetaminophen, metoclopramide, quinine, sulfasalazine |
| Nitric oxide | drug interactions | Class: Nitrates/Nitrites; Examples: nitric oxide, nitroglycerin, nitroprusside, nitrous oxide |
| Nitrofurantoin | drug interactions | Class: Antibiotics; Examples: dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides |
| Nitroglycerin | drug interactions | Class: Nitrates/Nitrites; Examples: nitric oxide, nitroglycerin, nitroprusside, nitrous oxide |
Every other medicine the epinephrine and lidocaine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Nitrous oxide | drug interactions | Class: Nitrates/Nitrites; Examples: nitric oxide, nitroglycerin, nitroprusside, nitrous oxide |
| Phenobarbital | drug interactions | Class: Anticonvulsants; Examples: phenobarbital, phenytoin, sodium valproate |
| Phenytoin | drug interactions | Class: Anticonvulsants; Examples: phenobarbital, phenytoin, sodium valproate |
| Prilocaine | drug interactions | Class: Local anesthetics; Examples: articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine |
| Primaquine | drug interactions | Class: Antimalarials; Examples: chloroquine, primaquine |
| Quinine | drug interactions | Class: Other drugs; Examples: acetaminophen, metoclopramide, quinine, sulfasalazine |
| Rasburicase | drug interactions | Class: Antineoplastic agents; Examples: cyclophosphamide, flutamide, hydroxyurea, isofamide, rasburicase |
| Ropivacaine | drug interactions | Class: Local anesthetics; Examples: articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine |
| Sulfasalazine | drug interactions | Class: Other drugs; Examples: acetaminophen, metoclopramide, quinine, sulfasalazine |
| Tetracaine | drug interactions | Class: Local anesthetics; Examples: articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine |
Source: FDA drug label (Xylocaine), NDA006488 (Fresenius Kabi Usa), as published by REMEDYREPACK INC., effective August 27, 2026 (SPL set 1414bcfc-1543-4ad4-83bd-4fc444a02e92), via openFDA; the full label on DailyMed
What do FAERS reports show for epinephrine and lidocaine?
The FDA Adverse Event Reporting System holds 53,158 reports that list epinephrine and lidocaine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5,467 are coded as a death and 19,416 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 next?
- Other amide local anesthetics
- the pharmacologic class, with prices and generics
- Epinephrine and lidocaine side effects
- the label's list beside FAERS reports
- Epinephrine and lidocaine shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other