Is Lidocaine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 26 valid registrations of Lidocaine, including 1% W-V LIDOCAINE HCL INJECTION USP (1 %, Solution for injection, SAR 9.00); 2% W-V LIDOCAINE HCL INJECTION USP (2 %, Solution for injection, SAR 8.40); AVALON AVOCAINE (10 %, Spray, SAR 24.45); LEDO 5% W-W OINTMENT (5 %, Ointment, SAR 4.40); LIDOCAINE 5 % OINTMENT (5 %, Ointment, SAR 8.15).

Is Lidocaine approved by the US FDA?

Drugs@FDA lists 169 application product lines for Lidocaine, including XYLOCAINE (Prescription); LIDOCAINE HYDROCHLORIDE (Prescription); LIDOCAINE (Prescription); LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE (Prescription); LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5% (Prescription).

Is Lidocaine on the WHO Model List of Essential Medicines?

Yes — 12.2. Antiarrhythmic medicines (core list): Ventricular tachyarrhythmia.

Are there safety signals or safety updates for Lidocaine?

US FDA: 14 entries (latest 2026-08-17).

Active substance

Lidocaine

SFDA 49
US FDA 169
Health Canada 46
US price lines 38
NHS prices 16
WHO EML 2
Safety 14

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
1% W-V LIDOCAINE HCL INJECTION USP	1 %	Solution for injection · intramuscular, subcutaneous	1 Vial	SAR 9.00	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
1% W-V LIDOCAINE HCL INJECTION USP	1 %	Solution for injection · intramuscular, subcutaneous	1 Vial	SAR 8.60	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
2% W-V LIDOCAINE HCL INJECTION USP	2 %	Solution for injection · intramuscular, subcutaneous	1 Vial	SAR 8.40	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
2% W-V LIDOCAINE HCL INJECTION USP	2 %	Solution for injection · intramuscular, subcutaneous	1 Vial	SAR 7.75	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
2% W-V LIDOCAINE HCL INJECTION USP	2 %	Solution for injection · intramuscular, subcutaneous	1 Vial	SAR 6.75	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
2% W-V LIDOCAINE HCL INJECTION USP	2 %	Solution for injection · intramuscular, subcutaneous	1 Vial	SAR 4.15	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
AVALON AVOCAINE	10 %	Spray · Topical	1 Pressurised container	SAR 24.45	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
LEDO 5% W-W OINTMENT	5 %	Ointment · Topical	1 Tube	SAR 4.40	Generic · Prescription	BATTERJEE PHARMACETICAL FACTORY	Valid
LIDOCAINE 5 % OINTMENT	5 %	Ointment · Topical	1 Tube	SAR 8.15	Generic · Prescription	Gulf Pharmaceutical Industries (Julphar)	Valid
LIDOCAINE HCL 1% AMPOULE	1 %	Solution for injection · Intravenous use	1 Ampoule	SAR 4.00	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
LIDOCAINE HCL 1% AMPOULE	1 %	Solution for injection · Intravenous use	1 Ampoule	SAR 3.15	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
LIDOCAINE HCL 1% AMPOULE	1 %	Solution for injection · Intravenous use	1 Ampoule	SAR 3.80	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
LIDOCAINE HCL 2% INJ 20ML	2 %	Solution for injection · Intravenous use	20 Ampoule	SAR 80.10	Generic · Prescription	B. BRAUN	Valid
LIDOCAINE HCL EMERGENCY SYRINGE 1%	1 %	Solution for injection · Intravenous use	1 Pre-filled syringe	SAR 21.45	Generic · Prescription	HOSPIRA INC	Valid
LIDOCAINE HCL EMERGENCY SYRINGE 2%	2 %	Solution for injection · Intravenous use	1 Pre-filled syringe	SAR 21.45	Generic · Prescription	HOSPIRA INC	Valid
LIDOCAINE HYDROCHLORIDE 1% solution for injection	1 %	Solution for injection · Parenteral use	100 Ampoule	SAR 247.50	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
LIOCAINE 2% GEL	2 %	Gel · Topical	1 Tube	SAR 7.70	Generic · OTC	HAYAT PHARMACEUTICAL INDUSTRIES	Valid
LIPRO SPRAY 10%	100 mg/g	Solution for spray · Topical	1 Bottle	SAR 22.30	Generic · Prescription	SAUDI PHARMACEUTICAL INDUSTRIES	Valid
RIALOCAINE 2 % Gel	2 %	Gel · Topical	1 Tube	SAR 7.35	Generic · OTC	RIYADH PHARMA	Valid
RIALOCAINE 2 % Gel	2 %	Gel · Topical	1 Tube	SAR 11.00	Generic · OTC	RIYADH PHARMA	Valid
SOLYO	10 mg/ml	Solution for injection · Intravenous use	10 Ampoule	SAR 7.00	Generic · Prescription	Medochemie Ltd	Valid
Senso	5 %	Transdermal patch · Transdermal use	30 Pouch	SAR 326.15	Generic · Prescription	Saudi Amarox	Valid
VERSATIS 5% MEDICATED PLASTER	5 %	Medicated plaster · Topical	5 Box	SAR 98.05	Generic · Prescription	STADA ARZNEIMITTEL GmbH	Valid
VERSATIS 5% MEDICATED PLASTER	5 %	Medicated plaster · Topical	30 Box	SAR 465.90	Generic · Prescription	STADA ARZNEIMITTEL GmbH	Valid
XYLOPHIL 2% GEL	2 %	Gel · Topical	1 Tube	SAR 6.00	Generic · OTC	PHILADELPHIA PHARMACEUTICAL	Valid

24 more — full table

Indications — CHI Daman Drug Formulary

ANESTHESIA; ARRHYTHMIA; BURN MANAGEMENT; PAIN MANAGEMENT IN CANCER PATIENTS; POSTOPERATIVE PAIN; RENAL AND URETERIC STONES; SPASTICITY; VENTRICULAR TACHYCARDIA

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

Product	Strength	Form · route	Applicant	Status	First approved
XYLOCAINE	2%; 1%; 0.5%; 1.5%	injectable · injection	FRESENIUS KABI USA	Prescription	19 Nov 1948
LIDOCAINE HYDROCHLORIDE	1%; 2%	injectable · injection	WEST-WARD PHARMS INT	Prescription	14 Feb 1972
LIDOCAINE	5%	ointment · topical	FOUGERA PHARMS INC	Prescription	30 Jun 1972
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%; 1.5%	injectable · injection	HOSPIRA	Prescription	28 Sep 1972
LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5%	5%	injectable · spinal	HOSPIRA	Prescription	23 Jan 1974
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	1%; 2%	injectable · injection	HIKMA PHARMS	Prescription	16 Jun 1975
LIDOCAINE HYDROCHLORIDE	1%; 2%	injectable · injection	INTL MEDICATION	Prescription	17 Sep 1975
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	2%; 4%	injectable · injection	FRESENIUS KABI USA	Prescription	26 Mar 1976
LIDOCAINE HYDROCHLORIDE	2%	jelly · topical	INTL MEDICATION	Prescription	7 Aug 1979
LARYNG-O-JET KIT	4%	solution · topical	INTL MEDICATION	Prescription	6 Mar 1980
LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	injectable · injection	BAXTER HLTHCARE	Prescription	22 Apr 1981
LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER	400MG/100ML	injectable · injection	BAXTER HLTHCARE	Prescription	22 Apr 1981
LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER	800MG/100ML	injectable · injection	BAXTER HLTHCARE	Prescription	22 Apr 1981
LIDOCAINE	5%	ointment · topical	SUN PHARMA CANADA	Prescription	17 Aug 1981
LIDOCAINE HYDROCHLORIDE	2%	solution · oral	PHARMOBEDIENT	Prescription	18 Nov 1982
LIDOCAINE HYDROCHLORIDE	4%	solution · topical	PHARMOBEDIENT	Prescription	18 Nov 1982
LIDOCAINE HYDROCHLORIDE	2%	injectable · injection	HOSPIRA	Prescription	16 May 1984
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	4%	injectable · injection	HOSPIRA	Prescription	16 May 1984
LIDOCAINE HYDROCHLORIDE	0.5%	injectable · injection	HOSPIRA	Prescription	17 May 1984
LIDOCAINE HYDROCHLORIDE	1%	injectable · injection	HOSPIRA	Prescription	17 May 1984
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	1%	injectable · injection	HOSPIRA	Prescription	31 Jul 1984
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	0.5%	injectable · injection	HOSPIRA	Prescription	31 Jul 1984
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	2%	injectable · injection	HOSPIRA	Prescription	31 Jul 1984
LIDOCAINE HYDROCHLORIDE	4%	solution · topical	HIKMA PHARMS	Prescription	3 Apr 1985
LIDOCAINE VISCOUS	2%	solution · oral	HIKMA PHARMS	Prescription	26 Apr 1985

144 more — full table

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AFTER SUN GEL	02499118	0.8 % / W/W	GEL · TOPICAL	FRUIT OF THE EARTH, INC
CATHEJELL	02370840	20 MG / G	GEL · TOPICAL	PHARMAZEUTISCHE FABRIK MONTAVIT GES M.B.H.
DR. NUMB	02354527	5 % / W/W	CREAM · TOPICAL	SHINPHARMA INC
ICY HOT WITH LIDOCAINE NO MESS ROLL ON PAIN RELIEF	02560992	4 % / W/W	GEL · TOPICAL	OPELLA CANADA INC.
JELIDO	02469146	20 MG / ML	GEL · TOPICAL	PENDOPHARM DIVISION OF PHARMASCIENCE INC
LIDOCAINE	02485311	4 %	GEL · TOPICAL	THE MENTHOLATUM COMPANY OF CANADA LTD
LIDOCAINE HYDROCHLORIDE INJECTION	02500647	10 MG / ML	SOLUTION · BLOCK/INFILTRATION	LABORATOIRE AGUETTANT
LIDOCAINE HYDROCHLORIDE INJECTION	02500655	20 MG / ML	SOLUTION · BLOCK/INFILTRATION	LABORATOIRE AGUETTANT
LIDOCAINE HYDROCHLORIDE INJECTION	02522268	100 MG / 5 ML	SOLUTION · INTRAVENOUS	LABORATOIRE AGUETTANT
LIDOCAINE HYDROCHLORIDE INJECTION	02542196	10 MG / ML	SOLUTION · BLOCK/INFILTRATION	JUNO PHARMA CANADA INC.
LIDOCAINE HYDROCHLORIDE INJECTION	02542218	20 MG / ML	SOLUTION · BLOCK/INFILTRATION	JUNO PHARMA CANADA INC.
LIDOCAINE HYDROCHLORIDE INJECTION USP	00436208	20 MG / ML	SOLUTION · INTRAVENOUS	PFIZER CANADA ULC
LIDOCAINE HYDROCHLORIDE INJECTION USP	00884154	10 MG / ML	SOLUTION · BLOCK/INFILTRATION	PFIZER CANADA ULC
LIDOCAINE HYDROCHLORIDE INJECTION USP	01901982	20 MG / ML	SOLUTION · BLOCK/INFILTRATION	PFIZER CANADA ULC
LIDOCAINE HYDROCHLORIDE INJECTION USP	02421984	10 MG / ML	SOLUTION · BLOCK/INFILTRATION	HIKMA CANADA LIMITED
LIDOCAINE HYDROCHLORIDE INJECTION USP	02421992	20 MG / ML	SOLUTION · BLOCK/INFILTRATION	HIKMA CANADA LIMITED
LIDOCAINE HYDROCHLORIDE INJECTION USP	02422018	10 MG / ML	SOLUTION · BLOCK/INFILTRATION	HIKMA CANADA LIMITED
LIDOCAINE HYDROCHLORIDE INJECTION USP	02422026	20 MG / ML	SOLUTION · BLOCK/INFILTRATION	HIKMA CANADA LIMITED
LIDOCAINE HYDROCHLORIDE INJECTION USP	02534827	10 MG / ML	SOLUTION · EPIDURAL; BLOCK/INFILTRATION	FORMATIVE PHARMA INC.
LIDOCAINE HYDROCHLORIDE INJECTION USP	02547856	20 MG / ML	SOLUTION · EPIDURAL; BLOCK/INFILTRATION	FORMATIVE PHARMA INC.
LIDOCAINE INJECTION BP	02462443	1 % / W/V	SOLUTION · BLOCK/INFILTRATION	AURO PHARMA INC
LIDOCAINE INJECTION BP	02462451	2 % / W/V	SOLUTION · BLOCK/INFILTRATION	AURO PHARMA INC
LIDOCAINE INJECTION BP	02530449	1 % / W/V	SOLUTION · BLOCK/INFILTRATION	EUGIA PHARMA INC.
LIDOCAINE INJECTION BP	02530457	2 % / W/V	SOLUTION · BLOCK/INFILTRATION	EUGIA PHARMA INC.
LIDODAN 4% TOPICAL SOLUTION	02419505	4 %	SOLUTION · TOPICAL	ODAN LABORATORIESLTD

21 more — full table

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	GLYDO 2% JELLY SYRINGE	$0.89771	per ML	23 Sep 2026
US NADAC	GLYDO 2% JELLY SYRINGE	$0.51624	per ML	23 Sep 2026
US NADAC	GNP LIDOCAINE HCL 4% CREAM	$0.05211	per GM	23 Sep 2026
US NADAC	LIDOCAINE 1%-EPI 1:100,000	$0.13908	per ML	22 Jul 2026
US NADAC	LIDOCAINE 2% VISCOUS SOLN	$0.08249	per ML	23 Sep 2026
US NADAC	LIDOCAINE 3% CREAM	$0.5593	per GM	23 Sep 2026
US NADAC	LIDOCAINE 3% CREAM	$0.36487	per GM	23 Sep 2026
US NADAC	LIDOCAINE 4% CREAM	$0.63452	per GM	23 Sep 2026
US NADAC	LIDOCAINE 4% CREAM	$0.42761	per GM	23 Sep 2026
US NADAC	LIDOCAINE 4% CREAM	$0.48988	per GM	23 Sep 2026
US NADAC	LIDOCAINE 4% PATCH	$1.10004	per EA	23 Sep 2026
US NADAC	LIDOCAINE 5% OINTMENT	$0.16213	per GM	23 Sep 2026
NHS Drug Tariff	Lidocaine 100mg/10ml (1%) solution for injection ampoules	£8.15	10 ampoule	1 Oct 2026
NHS Drug Tariff	Lidocaine 100mg/5ml (2%) solution for injection ampoules	£8.19	10 ampoule	1 Oct 2026
NHS Drug Tariff	Lidocaine 10mg/dose spray sugar free	£8.52	50 ml	1 Oct 2026
NHS Drug Tariff	Lidocaine 2% and Chlorhexidine gel	£10.50	60 ml	1 Oct 2026
NHS Drug Tariff	Lidocaine 2% and Chlorhexidine gel	£11.00	110 ml	1 Oct 2026
NHS Drug Tariff	Lidocaine 2% cream	£4.02	30 gram	1 Oct 2026
NHS Drug Tariff	Lidocaine 200mg/20ml (1%) solution for injection ampoules	£14.00	10 ampoule	1 Oct 2026
NHS Drug Tariff	Lidocaine 20mg/2ml (1%) solution for injection ampoules	£4.98	10 ampoule	1 Oct 2026
NHS Drug Tariff	Lidocaine 4% cream	£2.98	5 gram	1 Oct 2026
NHS Drug Tariff	Lidocaine 4% cream	£14.90	30 gram	1 Oct 2026
NHS Drug Tariff	Lidocaine 400mg/20ml (2%) solution for injection ampoules	£15.00	10 ampoule	1 Oct 2026
NHS Drug Tariff	Lidocaine 40mg/2ml (2%) solution for injection ampoules	£5.70	10 ampoule	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.

WHO WHO Model List of Essential Medicines (2025)

12.2. Antiarrhythmic medicines · core
Ventricular tachyarrhythmia
Parenteral > General injections > IV: 20 mg per mL in 5 mL ampoule (hydrochloride)
1.2. Local anaesthetics · core
Local anaesthetics
Parenteral > Locoregional injections > Spinal anaesthesia: 5% in 2 mL ampoule (hydrochloride) + 7.5% glucose solution | Parenteral > Locoregional injections > Other: 1% (hydrochloride); 2% (hydrochloride); 0.5% (hydrochloride) (EMLc) | Local > Topical > unspecified: 2 to 4% (hydrochloride)

Safety signals and safety-related labeling changes

US FDA 17 Aug 2026 LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 19 Dec 2025 ZINGO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 21 Nov 2025 AKTEN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 1 Apr 2025 XYLOCAINE — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 30 Oct 2024 XYLOCAINE W/ EPINEPHRINE — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 8 Apr 2021 ZTLIDO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 16 Dec 2020 SYNERA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 11 Dec 2018 PLIAGLIS — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 2 Nov 2018 EMLA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 2 Nov 2018 LIDODERM — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Drug Interactions
US FDA 2 Nov 2018 ORAQIX — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 2 Nov 2018 XYLOCAINE DENTAL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 2 Nov 2018 XYLOCAINE DENTAL WITH EPINEPHRINE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 12 Jul 2018 ROCEPHIN KIT — safety-related labeling change
Labeling sections changed: Warnings and Precautions

All safety entries for lidocaine →

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.