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 13 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dr Sabharwals	METHYL SALICYLATE 10% GEL PATCH	Dr. Sabharwal's Wound Care	4a7790bb-25cb-72b8-e063-6294a90a6b9c	2026-06-29	Warnings	Exact identifier application number: M017
Calamine Plus Pramoxine HCl	CALAMINE PLUS SPRAY	Target Corporation	36602b7a-99c0-f6a4-e063-6294a90a8758	2026-06-29	Warnings	Exact identifier application number: M017
FIRST SHIELD	BENZALKONIUM CHLORIDE, LIDOCAINE HCI	Unishield	f86f7446-b741-9f40-e053-6394a90a4422	2026-06-29	Warnings	Exact identifier application number: M017
MQ Lidocaine Pain Relief Patch	LIDOCAINE PAIN RELIEF PATCH	Zhengzhou Miaoqi Medical Technology Co., Ltd.	5560cdab-cee8-f6ec-e063-6294a90ad024	2026-06-29	Warnings	Exact identifier application number: M017
GNP Lidocaine Maximum Strength	LIDOCAINE HCL	AMERISOURCE BERGEN	9f559c20-c9ac-e480-e053-2a95a90a8fce	2026-06-29	Warnings	Exact identifier application number: M017
NUMBING	LIDOCAINE	YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED	5553385d-c1e6-1242-e063-6394a90aa5a7	2026-06-28	Warnings	Exact identifier application number: M017
MOROVAN	LIDOCAINE	HONG KONG UNORDERED TRADING CO., LIMITED	550c8d2d-e0d7-1531-e063-6394a90a374d	2026-06-25	Warnings	Exact identifier application number: M017
Marie Originals Medicated Outdoor Anti Itch	HYDROCORTISONE SPRAY	Marie's Original Formulas, LLC	5517ee5f-1c51-cfd6-e063-6294a90af56f	2026-06-25	Warnings	Exact identifier application number: M017
Marie Originals Medicated Outdoor Anti Itch	HYDROCORTISONE SPRAY	Marie's Original Formulas LLC	55188ede-68cd-fcc6-e063-6394a90a5c58	2026-06-25	Warnings	Exact identifier application number: M017
Hydrocortisone with Aloe	HYDROCORTISONE CREAM 1%	NuCare Pharmaceuticals, Inc.	54f07a23-213f-ca46-e063-6394a90a0034	2026-06-24	Warnings	Exact identifier application number: M017
Terramed Just Think Comfort HerpCare EXTERNAL ANALGESIC FOR THE TEMPORARY RELIEF OF ITCHING AND IRRITATION	MENTHOL,PRAMOXINE HYDROCHLORIDE	Rida LLC	b62d09e4-7ced-49a9-8c83-3a8ef580f25a	2026-06-23	Warnings	Exact identifier application number: M017
Terramed Just Think Comfort HerpCare Intimate Wash EXTERNAL ANALGESIC FOR THE TEMPORARY RELIEF OF ITCHING AND IRRITATION	PRAMOXINE HYDROCHLORIDE	Rida LLC	5b2cb1bd-2f1e-4670-b40e-6c058bfd12a2	2026-06-23	Warnings	Exact identifier application number: M017
Pain Relieving cleansing spary	BENZALKONIUM CHLORIDE AND LIDOCAINE HCI	Trifecta Pharmaceuticals USA, LLC.	48edbb8d-0c35-91d8-e063-6394a90a71b8	2026-06-19	Warnings	Exact identifier application number: M017
Pain Relief	MENTHOL	Trifecta Pharmaceuticals USA, LLC.	493ab515-5cda-7b5a-e063-6294a90a295b	2026-06-19	Warnings	Exact identifier application number: M017
Tiger Balm Muscle Rub	METHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC)	Haw Par Healthcare Ltd.	011fc383-10bc-44cf-a67c-4be45fef33e0	2026-06-19	Warnings	Exact identifier application number: M017
CVS Health Scalp Relief	SALICYLIC ACID	CVS Health	8de46015-817c-4cd9-95f8-293424f2a5c4	2026-06-19	Warnings	Exact identifier application number: M017
Careland Kinesiology Dual Action Pain Relieving Tape	LIDOCAINE	Planet (Anhui) Pharmaceutical Co., Ltd.	67e0b3c5-e88e-4c48-a1e8-39f502ac249d	2026-06-18	Warnings	Exact identifier application number: M017
Zensa	LIDOCAINE	Alera Skin Care Products Inc.	549348ec-2eb2-3781-e063-6294a90a2f4a	2026-06-18	Warnings	Exact identifier application number: M017
SprayPain Away	CAPSAICIN	Proximity Capital Partners LLC dba Asutra	c603e999-2316-496a-e053-2995a90ab4ed	2026-06-17	Warnings	Exact identifier application number: M017
SprayPain Away Lavender	CAPSAICIN	Proximity Capital Partners LLC dba Asutra	547e2167-ade0-ac7e-e063-6294a90a18ea	2026-06-17	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