Prescription medicine
Lidocaine and tetracaine Brand names: Pliaglis; first approved as Synera
Lidocaine and tetracaine (Synera) is a prescription medicine with an FDA approval on record since 2005. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the lidocaine and tetracaine FDA label on DailyMed (effective March 9, 2026, IPG PHARMACEUTICALS, INC.); the NDA 21623 record on Drugs@FDA; every lidocaine and tetracaine label on DailyMed.
Highlights of the record
FDA label of March 9, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usagePLIAGLIS is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal.
Forms and strengths
- 70 mg/g / 70 mg/g
Cream.
On the market
- Earliest approval on file
- June 23, 2005 Synera, Galen Specialty; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- January 14, 2031 Pliaglis cream; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2021 0 Class I among all firms' recalls; latest January 21, 2021
- FAERS reports
- 45 through July 30, 2026
What is lidocaine and tetracaine used for?
From the label: indications and usagePLIAGLIS is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal. PLIAGLIS is a combination of lidocaine, an amide local anesthetic, and tetracaine, an ester local anesthetic, indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal.
FDA pharmacologic class: Amide Local Anesthetic, Antiarrhythmic and Ester Local Anesthetic.
Source: FDA drug label (PLIAGLIS), NDA021717 (Crescita Therap), as published by IPG PHARMACEUTICALS, INC., effective March 9, 2026 (SPL set d854faa5-0af8-4684-b5cd-a0b8a91fb7cd), via openFDA; the full label on DailyMed
Is there a generic for lidocaine and tetracaine (Synera)?
No generic lidocaine and tetracaine is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists no patent for Synera patch; a patent listed only for Pliaglis cream runs to January 14, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2005 earliest approval on file
- 2031 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has lidocaine and tetracaine been recalled?
The FDA's Enforcement Report lists 1 recall naming lidocaine and tetracaine since 2021: 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 |
|---|---|---|---|
| January 21, 2021 | Class II | Stanley Specialty Pharmacy Compounding and Wellness Center | Superpotent Drug. Lidocaine higher concentration than listed |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the lidocaine and tetracaine label say about other medicines?
The lidocaine and tetracaine label names 25 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, ifosfamide, rasburicase |
| Dapsone | drug interactions | Class: Antibiotics; Examples: dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides |
| 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 and precautions | 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 |
| Mexiletine | drug interactions | Antiarrhythmic Drugs PLIAGLIS should be used with caution in patients receiving Class I antiarrhythmic drugs (such as tocainide and mexiletine) since the systemic toxic effects are thought to be additive and potentially synergistic with lidocaine and tetracaine. |
| Nitric oxide | drug interactions | Class: Nitrates/Nitrites; Examples: nitric oxide, nitroglycerin, nitroprusside, nitrous oxide |
Every other medicine the lidocaine and tetracaine label names
| Medicine named | Section | What the label says |
|---|---|---|
| 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 |
| 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, ifosfamide, 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 |
Source: FDA drug label (PLIAGLIS), NDA021717 (Crescita Therap), as published by IPG PHARMACEUTICALS, INC., effective March 9, 2026 (SPL set d854faa5-0af8-4684-b5cd-a0b8a91fb7cd), via openFDA; the full label on DailyMed
What do FAERS reports show for lidocaine and tetracaine?
The FDA Adverse Event Reporting System holds 45 reports that list lidocaine and tetracaine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 5 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.
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 tetracaine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other