Is Lidocaine + Prilocaine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 10 valid registrations of Lidocaine + Prilocaine, including ENNLA 5% Cream (25,25 mg/g,mg/g, Cream, SAR 9.90); Imla (2.50,2.50 % (W/W),% (W/W), Cream, SAR 47.00); Lidapro (2.5,2.5 % (W/W),% (W/W), Cream, SAR 47.00); Lignox (2.5,2.5 % (W/W),% (W/W), Cream, SAR 56.40); PRILA 5% CREAM (2.5,2.5 %,%, Cream, SAR 55.00).

Is Lidocaine + Prilocaine approved by the US FDA?

Drugs@FDA lists 11 application product lines for Lidocaine + Prilocaine, including LIDOCAINE AND PRILOCAINE (Prescription); LIDOCAINE AND PRILOCAINE (Prescription); ORAQIX (Prescription); LIDOCAINE AND PRILOCAINE (Prescription); LIDOCAINE AND PRILOCAINE (Prescription).

Is Lidocaine + Prilocaine authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Lidocaine + Prilocaine: Fortacin.

Active substances

Lidocaine + Prilocaine

SFDA 10
US FDA 11
EMA 2
Health Canada 3
US price lines 2
NHS prices 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ENNLA 5% Cream	25,25 mg/g,mg/g	Cream · Topical	1 Tube	SAR 9.90	Generic · Prescription	DEEF PHARMACEUTICAL INDUSTRIES	Valid
ENNLA 5% Cream	25,25 mg/g,mg/g	Cream · Topical	1 Tube	SAR 29.70	Generic · Prescription	DEEF PHARMACEUTICAL INDUSTRIES	Valid
ENNLA 5% Cream	25,25 mg/g,mg/g	Cream · Topical	1 Tube	SAR 59.40	Generic · Prescription	DEEF PHARMACEUTICAL INDUSTRIES	Valid
Imla	2.50,2.50 % (W/W),% (W/W)	Cream · Topical	1 Tube	SAR 47.00	Generic · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid
Lidapro	2.5,2.5 % (W/W),% (W/W)	Cream · Topical	5 Tube	SAR 47.00	Generic · Prescription	Dallah Pharma Company	Valid
Lignox	2.5,2.5 % (W/W),% (W/W)	Cream · Topical	1 Tube	SAR 56.40	Generic · Prescription	SAUDI PHARMACEUTICAL INDUSTRIES	Valid
Lignox	2.5,2.5 % (W/W),% (W/W)	Cream · Topical	5 Tube	SAR 47.00	Generic · Prescription	SAUDI PHARMACEUTICAL INDUSTRIES	Valid
Lignox	2.5,2.5 % (W/W),% (W/W)	Cream · Topical	1 Tube	SAR 9.40	Generic · Prescription	SAUDI PHARMACEUTICAL INDUSTRIES	Valid
PRILA 5% CREAM	2.5,2.5 %,%	Cream · Topical	5 Tube	SAR 55.00	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
Prila	2.5,2.5 %,%	Cream · Topical	1 Tube	SAR 66.00	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid

Indications — CHI Daman Drug Formulary

ANESTHESIA; HEMORRHOIDS

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
LIDOCAINE AND PRILOCAINE	2.5%;2.5%	cream · topical	FOUGERA PHARMS	Prescription	18 Aug 2003
LIDOCAINE AND PRILOCAINE	2.5%;2.5%	cream · topical	ENCUBE	Prescription	27 Aug 2003
ORAQIX	2.5%;2.5%	gel · periodontal	DENTSPLY PHARM	Prescription	19 Dec 2003
LIDOCAINE AND PRILOCAINE	2.5%;2.5%	cream · topical	PADAGIS US	Prescription	27 Jul 2021
LIDOCAINE AND PRILOCAINE	2.5%;2.5%	cream · topical	ALEMBIC	Prescription	8 Apr 2022
LIDOCAINE AND PRILOCAINE	2.5%;2.5%	cream · topical	ZYDUS LIFESCIENCES	Prescription	17 Dec 2024
EMLA	2.5%;2.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	cream · topical	TEVA BRANDED PHARM	Discontinued	30 Dec 1992
EMLA	2.5%;2.5%	disc · topical	ASTRAZENECA	Discontinued	4 Feb 1998
LIDOCAINE AND PRILOCAINE	2.5%;2.5%	cream · topical	HIKMA PHARMS	Discontinued	25 Sep 2003
LIDOCAINE AND PRILOCAINE	2.5%;2.5%	cream · topical	PAI HOLDINGS PHARM	Discontinued	29 Jun 2018
LIDOCAINE AND PRILOCAINE	2.5%;2.5%	cream · topical	CHARTWELL RX	Discontinued	21 Sep 2020

EMA European Union — centrally authorised medicines

Fortacin Recordati Ireland Ltd. · Authorised · authorised 15 Nov 2013 · ATC N01BB20

Therapeutic indication (EMA)

Treatment of primary premature ejaculation in adult men.

Senstend Plethora Pharma Solutions Limited · Withdrawn · authorised 14 Nov 2019 · ATC N01BB20

Therapeutic indication (EMA)

Senstend is indicated for the treatment of primary premature ejaculation in adult men.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
EMLA CREAM	00886858	2.5 %; 2.5 %	CREAM · TOPICAL	ASPEN PHARMACARE CANADA INC.
EMLA PATCH	02057794	2.5 %; 2.5 %	PATCH · TOPICAL	ASPEN PHARMACARE CANADA INC.
ORAQIX	02325993	2.5 %; 2.5 %	GEL · TOPICAL	DENTSPLY CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	LIDOCAINE-PRILOCAINE 2.5%-2.5% CREAM	$0.2317	per GM	23 Sep 2026
US NADAC	LIDOCAINE-PRILOCAINE 2.5%-2.5% CREAM	$1.33527	per GM	22 Jul 2026
NHS Drug Tariff	Lidocaine 2.5% / Prilocaine 2.5% cream	£3.74	5 gram	1 Oct 2026
NHS Drug Tariff	Lidocaine 2.5% / Prilocaine 2.5% cream	£14.00	25 gram	1 Oct 2026
NHS Drug Tariff	Lidocaine 2.5% / Prilocaine 2.5% cream	£15.00	30 gram	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Components

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.