Sonacaine Topical Anesthetic With Menthol

Product NDC: 62221-935
11-digit product format: 622210935
Labeler code: 62221
Product ID: 62221-935_09c2a084-c6bb-04eb-e063-6394a90adbcf
Type: HUMAN OTC DRUG
Nonproprietary name: LIDOCAINE
Dosage form: GEL
Route: TOPICAL
Labeler: Filltech USA, LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-05-02
Substance: LIDOCAINE
Active strength: 4 g/100g
Pharmacologic classes: Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Sonacaine Topical Anesthetic With Menthol
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIDOCAINE	4 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
98PI200987	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1291672	Internal RxNorm lookup
1291677	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ca54c6da-4bf2-4e63-ba7f-a69c4f9c431a	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62221-935-02	Sonacaine Topical Anesthetic With Menthol	60 g in 1 BOTTLE	GEL	60		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LIDOCAINE	ACTIVE INGREDIENT	98PI200987	SONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]	1
LIDOCAINE	ACTIVE MOIETY	98PI200987	SONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	SONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	SONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]	1
CALENDULA OFFICINALIS FLOWER	INACTIVE INGREDIENT	P0M7O4Y7YD	SONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]	1
CHAMOMILE	INACTIVE INGREDIENT	FGL3685T2X	SONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]	1
COMFREY LEAF	INACTIVE INGREDIENT	DG4F8T839X	SONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]	1
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	SONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	SONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	SONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]	1
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	SONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	SONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	SONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	SONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	SONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	SONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	SONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62221-935	SONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]	4	Current NDC, Legacy NDC, 1 package rows	20231110_ca54c6da-4bf2-4e63-ba7f-a69c4f9c431a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 94 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mqforu Pain Patch	PAIN PATCH	Zhengzhou Miaoqi Medical Technology Co., Ltd.	1f878abd-54cd-1963-e063-6294a90a1884	2025-04-22	Warnings	Exact identifier application number: M017
PICKLEBALM LIDOCAINE WITH MENTHOL ARNICA CUCUMBER SEED ROLL ON	LIDOCAINE, MENTHOL	Compass Health Brands Corp.	2c25fa5e-9546-ba74-e063-6294a90aadf4	2025-04-22	Warnings	Exact identifier application number: M017
PICKLEBALM LIDOCAINE WITH MENTHOL ARNICA CUCUMBER SEED BALM	LIDOCAINE, MENTHOL	Compass Health Brands Corp.	2bd8cfb6-ab6c-9e04-e063-6294a90a2d52	2025-04-22	Warnings	Exact identifier application number: M017
Maximum Strength 4% Lidocaine Patch	LIDOCAINE	Pharmheal	32e57c0f-d138-88dc-e063-6394a90ac085	2025-04-16	Warnings	Exact identifier application number: M017
COLD HOT CHINESE RED TIGER PAIN RELIEF GeI-Patch	MENTHOL	Guangzhou Zhupuyou E-commerce Co., Ltd	32b7d73c-a191-7843-e063-6394a90aa631	2025-04-14	Warnings	Exact identifier application number: M017
Methyl Salicylate 25% Cream	METHYL SALICYLATE	MARCELLA HEALTH	32c153c7-de30-504e-e063-6294a90a4020	2025-04-14	Warnings	Exact identifier application number: M017
Dollar General Cold-Hot Medicated Patches	MENTHOL	DOLGENCORP, LLC	e13ab4d3-eb58-4874-925a-6a59df4dd29a	2025-04-14	Warnings	Exact identifier application number: M017
AY BENDITO - PAIN RELIEF	CAMPHOR, MENTHOL	AY BENDITO INTERNATIONAL, INC	b97f6b71-7de7-3217-e053-2a95a90aa426	2025-04-14	Warnings	Exact identifier application number: M017
AY BENDITO - THERMOACTIVE	CAMPHOR, MENTHOL	AY BENDITO INTERNATIONAL, INC	bbf0d85e-269d-0342-e053-2995a90ac63c	2025-04-14	Warnings	Exact identifier application number: M017
Biofreeze Menthol	MENTHOL, UNSPECIFIED FORM	Reckitt Benckiser LLC	71a36691-9d9e-479d-bfdc-6f6b192ad2d0	2025-04-11	Warnings	Exact identifier application number: M017
Eagle Medicated	MENTHOL METHYL SALICYLATE	Borden Company (Private) Limited	da3358ae-8679-6045-e053-2a95a90a50e3	2025-04-10	Warnings	Exact identifier application number: M017
Jointflex	JOINTFLEX	Strides Consumer LLC	b82ec69c-bd00-400b-bd94-ac15fb620f9b	2025-04-09	Warnings	Exact identifier application number: M017
Zepol Topical Analgesic	CAMPHOR, MENTHOL	Laboratorios Zepol S.A.	ca20ade6-9b35-40bb-b3b2-fc3a0e1eece9	2025-04-09	Warnings	Exact identifier application number: M017
Jointflex	CAMPHOR	Strides Consumer LLC	cb5ca02b-0bc1-4b0b-b4b1-abef3222aa56	2025-04-09	Warnings	Exact identifier application number: M017
Foster and Thrive Lidocaine Pain Relief Patch	LIDOCAINE 4%	Strategic Sourcing Services LLC	32456887-aa09-8912-e063-6394a90a4ae7	2025-04-08	Warnings	Exact identifier application number: M017
MUSCLE	MENTHOL	WATER-JEL TECHNOLOGIES	1af399af-07b0-4899-9bcc-1e244b63b1cf	2025-04-08	Warnings	Exact identifier application number: M017
Lidocaine with Menthol	LIDOCAINE HCL AND MENTHOL	Kareway Product, Inc.	9ee46a5b-d00c-4254-e053-2995a90aeb3a	2025-04-08	Warnings	Exact identifier application number: M017
Foster and Thrive Lidocaine Pain Relief Patch	LIDOCAINE 4%	Strategic Sourcing Services LLC	324802c9-e2c2-bf74-e063-6394a90a8697	2025-04-08	Warnings	Exact identifier application number: M017
OARS AND ALPS MUSCLE RECOVERY BALM	MENTHOL, METHYL SALICYLATE	Cosco International, Inc	8745802f-018d-4cf8-bbf3-3b04c8f54538	2025-04-08	Warnings	Exact identifier application number: M017
NOVUM APR	MENTHOL	NOVUM SOLUTIONS INC	1b869a1f-5787-4d03-a546-43a8217b2b2c	2025-04-07	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
98PI200987	LIDOCAINE	137-58-6	LIDOCAINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1291672	lidocaine 4 % Topical Gel	PSN	ca54c6da-4bf2-4e63-ba7f-a69c4f9c431a	4
1291677	sonacaine 4 % Topical Gel	PSN	ca54c6da-4bf2-4e63-ba7f-a69c4f9c431a	4
1291677	lidocaine 0.04 MG/MG Topical Gel [Sonacaine]	SBD	ca54c6da-4bf2-4e63-ba7f-a69c4f9c431a	4
1291672	lidocaine 0.04 MG/MG Topical Gel	SCD	ca54c6da-4bf2-4e63-ba7f-a69c4f9c431a	4
1291672	lidocaine 4 % Topical Gel	SY	ca54c6da-4bf2-4e63-ba7f-a69c4f9c431a	4
1291677	Sonacaine 0.04 MG/MG Topical Gel	SY	ca54c6da-4bf2-4e63-ba7f-a69c4f9c431a	4
1291677	Sonacaine 4 % Topical Gel	SY	ca54c6da-4bf2-4e63-ba7f-a69c4f9c431a	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62221-935-02	62221093502	60 g in 1 BOTTLE (62221-935-02)	60 g	2012-05-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sonacaine Topical Anesthetic Gel With Menthol	Filltech USA, LLC	2023-11-09	HUMAN OTC DRUG LABEL	4