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Fixed-dose combination

Lidocaine and Prilocaine

Also known as lidocaine, prilocaine
Available on requestPain and anaesthesia
Presentations
2
Brands
1
Manufacturers
1
Available from stock
0

Lidocaine and Prilocaine is a fixed-dose combination of an amide local anesthetic and an antiarrhythmic indicated for adults who require localized anesthesia in periodontal pockets during scaling and/or root planing. MedsAcross supplies Lidocaine and Prilocaine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Amide Local Anesthetic, Antiarrhythmic, Local Anesthesia
ATC classification
N01BB20 Lidocaine and Prilocaine · Local anesthetic, subgroup N01BB
US FDA first approval
30 December 1992
EU status
Authorised
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Topical, Periodontal
Dosage forms
Cream, Gel
Fixed-dose combination of
Lidocaine, Prilocaine
Identifiers
RxCUI 166283CAS 101362-25-8Q4019783

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

Oraqix is an amide local anesthetic indicated for adults who require localized anesthesia in periodontal pockets during scaling and/or root planing.

Source: US FDA prescribing information

How it works

Lidocaine and prilocaine belong to the amide class of local anesthetics. Both lidocaine and prilocaine block sodium ion channels required for the initiation and conduction of neuronal impulses, resulting in local anesthesia.

Source: US FDA prescribing information

Dosing overview

Use the included blunt-tipped applicator and the dispenser, which is sold separately, to apply gel to gingival margins and periodontal pockets. May be reapplied as needed up to a maximum of 5 cartridges per treatment session.

Source: US FDA prescribing information

Contraindications

Oraqix is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to any other component of the product. A history of hypersensitivity to local anesthetics of the amide type. A history of hypersensitivity to any component of the product

Source: US FDA prescribing information

Warnings and precautions

Methemoglobinemia: Cases of methemoglobinemia have been reported in association with local anesthetic use. DO NOT INJECT. Allergic and anaphylactic reactions can occur. Avoid contact with eyes. Use with caution in patients with severe hepatic disease

Source: US FDA prescribing information

Side effects

Most common adverse reactions (incidence >15%) are application site reactions including pain, soreness, irritation, numbness, ulcerations, vesicles, edema, abscess and/or redness.

Source: US FDA prescribing information

Interactions

Other local anesthetics or agents structurally related to local anesthetics. Drugs That May Cause Methemoglobinemia When Used With ORAQIX

Source: US FDA prescribing information

Storage

Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F). At temperatures below +5°C Oraqix may become opaque. This opacity will disappear when the cartridge is warmed to room temperature. DO NOT FREEZE.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

2 presentations of Lidocaine and Prilocaine, sorted by availability.

MedicineActive ingredientManufacturerRegisterAvailability
Lidocaine and Prilocaine 25 mg/25 mg per g creamTopicalGeneric nameLidocaine and Prilocaine—US FDAAvailable on request
Oraqix 25 mg/25 mg per g gelPeriodontalLidocaine and PrilocaineDentsply PharmaceuticalUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 30 December 1992Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Lidocaine and Prilocaine available for export from India?

Yes, on request. MedsAcross lists 2 presentations of Lidocaine and Prilocaine and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Lidocaine and Prilocaine have?

The catalogue lists 1 brand names for Lidocaine and Prilocaine, including Oraqix.

Is Lidocaine and Prilocaine approved by the US FDA?

Yes. The US FDA first approved Lidocaine and Prilocaine on 30 December 1992, according to Drugs@FDA.

Is Lidocaine and Prilocaine authorised in the European Union?

Yes. Lidocaine and Prilocaine has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Lidocaine and Prilocaine need cold chain shipping?

No listed presentation of Lidocaine and Prilocaine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Lidocaine and Prilocaine in?

Lidocaine and Prilocaine is classified under ATC code N01BB20 (Lidocaine and Prilocaine).

References

  1. Oraqix prescribing information (Dentsply Pharmaceutical). U.S. National Library of Medicine, DailyMed. Retrieved 21 April 2026
  2. Fortacin: European public assessment report (EPAR). European Medicines Agency. Retrieved 3 February 2025

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