Prescription medicine
Lidocaine and prilocaine Brand names: Oraqix; first approved as Emla
Lidocaine and prilocaine (Emla) is a prescription medicine with an FDA approval on record since 1992. FDA's NDC Directory lists it from 12 generic labelers, and pharmacies paid $0.232 per gram (Lidocaine-prilocaine 2.5%-2.5% cream) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the lidocaine and prilocaine FDA label on DailyMed (effective March 30, 2026, Padagis US LLC); the NDA 19941 record on Drugs@FDA; every lidocaine and prilocaine label on DailyMed.
Highlights of the record
FDA label of March 30, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageLidocaine and Prilocaine Cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on:
normal intact skin for local analgesia.
Forms and strengths
- 25 mg/g / 25 mg/g
Cream; gel.
On the market
- Earliest approval on file
- December 30, 1992 Emla, Teva Branded Pharm; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 8 first August 18, 2003; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 13 of which 12 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.232 per gram Lidocaine-prilocaine 2.5%-2.5% cream
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2022 0 Class I among all firms' recalls; latest April 13, 2022
- FAERS reports
- 1,384 through July 30, 2026
What is lidocaine and prilocaine used for?
From the label: indications and usageLidocaine and Prilocaine Cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on:
normal intact skin for local analgesia.
genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia. Lidocaine and Prilocaine Cream is not recommended in any clinical situation when penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies (see WARNINGS).
FDA pharmacologic class: Amide Local Anesthetic and Antiarrhythmic.
Source: FDA drug label (LIDOCAINE AND PRILOCAINE), Padagis US LLC, effective March 30, 2026 (SPL set 6e1635f7-dcae-441b-bbf7-495661fb66ae), via openFDA; the full label on DailyMed
Is there a generic for lidocaine and prilocaine (Emla)?
The FDA approved the first generic lidocaine and prilocaine on August 18, 2003. 8 generic applications are approved; 5 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 and prilocaine from 12 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1992 earliest approval on file
- 2003 first generic approved
- 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 and prilocaine (Emla)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.232 per gram (Lidocaine-prilocaine 2.5%-2.5% cream), down 14% from $0.269 on October 8, 2025. 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-prilocaine 2.5%-2.5% cream (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Lidocaine-prilocaine 2.5%-2.5% cream | Generic | $0.232 per gram | n/a | -14% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has lidocaine and prilocaine been recalled?
The FDA's Enforcement Report lists 1 recall naming lidocaine and prilocaine since 2022: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the lidocaine and prilocaine label say about other medicines?
The lidocaine and prilocaine label names 28 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 |
| Amiodarone | drug interactions | … sulfasalazine Specific interaction studies with lidocaine/prilocaine and class III anti-arrhythmic drugs (e.g., amiodarone, bretylium, sotalol, dofetilide) have not been performed, but caution is advised (see WARNINGS). |
| 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, ifosfamide, rasburicase |
| Dapsone | drug interactions | Class: Antibiotics; Examples: dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides |
| Dofetilide | drug interactions | … studies with lidocaine/prilocaine and class III anti-arrhythmic drugs (e.g., amiodarone, bretylium, sotalol, dofetilide) have not been performed, but caution is advised (see WARNINGS). |
| Flutamide | drug interactions | Class: Antineoplastic agents; Examples: cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase |
| Hydroxyurea | drug interactions | Class: Antineoplastic agents; Examples: cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase |
| Ifosfamide | drug interactions | Class: Antineoplastic agents; Examples: cyclophosphamide, flutamide, hydroxyurea, ifosfamide, 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 |
Every other medicine the lidocaine and prilocaine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Mexiletine | drug interactions | … patients receiving Class I antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic. |
| 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 |
| 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 |
| 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, ifosfamide, rasburicase |
| Ropivacaine | drug interactions | Class: Local anesthetics; Examples: articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine |
| Sotalol | drug interactions | … and class III anti-arrhythmic drugs (e.g., amiodarone, bretylium, sotalol, dofetilide) have not been performed, but caution is advised (see WARNINGS). |
| 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 (LIDOCAINE AND PRILOCAINE), Padagis US LLC, effective March 30, 2026 (SPL set 6e1635f7-dcae-441b-bbf7-495661fb66ae), via openFDA; the full label on DailyMed
What do FAERS reports show for lidocaine and prilocaine?
The FDA Adverse Event Reporting System holds 1,384 reports that list lidocaine and prilocaine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 126 are coded as a death and 441 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
- Lidocaine and prilocaine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other