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 30 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RICHTOFIT RAPID ACTIVE ARTHRITIS	MENTHOL AND CAMPHOR	RICHTOFIT LIMITED LIABILITY COMPANY	4b1cdab1-3e50-4ec3-e063-6394a90af75e	2026-03-12	Warnings	Exact identifier application number: M017
5Kind DMSO 4 Lidocaine HCl Pain Relieving	LIDOCAINE HYDROCHLORIDE, MENTHOL	5KIND TRADING LTD	67d8d045-7fa0-46c2-8072-645d8823903b	2026-03-11	Warnings	Exact identifier application number: M017
Rapid Relief	PAIN RELIEF PATCH LIDOCAINE 4%	RAPID AID VIET NAM COMPANY LIMITED	4ca541b4-7afe-77c5-e063-6294a90ad692	2026-03-10	Warnings	Exact identifier application number: M017
Lidocaine Cream, 4%	LIDOCAINE	IPG PHARMACEUTICALS, INC.	7775bfdd-7eac-4f09-b83f-fc4a16a24558	2026-03-10	Warnings	Exact identifier application number: M017
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	CHEMCO CORPORATION	4c989283-9a27-e8d2-e063-6294a90a8bfa	2026-03-09	Warnings	Exact identifier application number: M017
Prequel Anti-Itch Solution Medicated Calming	MEDICATED CALMING LOTION	The Center Brands, LLC	419fa45b-992b-676e-e063-6394a90add81	2026-03-09	Warnings	Exact identifier application number: M017
Careland Lidocaine 4 Plus Menthol Pain Relieving Gel Patches for back, neck shoulders knees and elbows with border	LIDOCAINE, MENTHOL	Planet (Anhui) Pharmaceutical Co., Ltd.	1fda69f7-2bb6-42fc-bcef-677e7b3d7f01	2026-03-09	Warnings	Exact identifier application number: M017
Careland Lidocaine 4 plus menthol pain relieving gel-patches with border for knee	MENTHOL, LAUROCAPRAM	Planet (Anhui) Pharmaceutical Co., Ltd.	7577625c-87eb-4639-aeab-8a2ab97033fd	2026-03-09	Warnings	Exact identifier application number: M017
Careland Lidocaine Pain Relieving	LIDOCAINE	Planet (Anhui) Pharmaceutical Co., Ltd.	7de99b81-b3b3-49f1-8aa7-2ff42e1b46a4	2026-03-09	Warnings	Exact identifier application number: M017
Rapid Relief	PAIN RELIEF PATCH LIDOCAINE 4%	RAPID AID VIET NAM COMPANY LIMITED	4ca35030-958c-8f62-e063-6294a90a4d63	2026-03-09	Warnings	Exact identifier application number: M017
Welmate Lidocaine Pain Relieving Patch	LIDOCAINE	YYBA Corp	cff71b75-fc4e-29ac-e053-2995a90abd50	2026-03-06	Warnings	Exact identifier application number: M017
Heal and Rescue Bunion Pain Relief	LIDOCAINE HCL, MENTHOL	Rooftop Consumer Health, Inc	4c60d4d3-e0a9-6f93-e063-6394a90a16af	2026-03-06	Warnings	Exact identifier application number: M017
JUST CBD - PAIN RELIEF	MENTHOL, CAMPHOR	Just Brands LLC	4c493c0b-c58e-cb56-e063-6394a90a9395	2026-03-05	Warnings	Exact identifier application number: M017
Hug a BooBoo Medicated booboo Wipes	BENZOCAINE	Lights Medical Manufacture Co., Ltd.	509aaafc-2ef7-4205-818c-7ff5b146e159	2026-03-04	Warnings	Exact identifier application number: M017
CVS Foot Pain	LIDOCAINE HYDROCHLORIDE	CVS Pharmacy	4c3350c3-2e3e-093c-e063-6394a90a3475	2026-03-04	Warnings	Exact identifier application number: M017
Game On Sport	MENTHOL	Natural Essentials, Inc	4c3411dc-5378-bd93-e063-6394a90a8406	2026-03-04	Warnings	Exact identifier application number: M017
Hydrocortisone 1%	HYDROCORTISONE	Trifecta Pharmaceuticals Usa Llc	f4d4a56b-b4b7-9a07-e053-2a95a90ad853	2026-03-04	Warnings	Exact identifier application number: M017
Hydrocortisone 1%	HYDROCORTISONE	Trifecta Pharmaceuticals Usa Llc	9987165c-1a0f-dd57-e053-2a95a90ae735	2026-03-04	Warnings	Exact identifier application number: M017
Walgreens Unscented Pain Relieving	LIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOL	Walgreen Co.	41eadb4f-2ca5-42a1-e063-6294a90ab4e2	2026-03-04	Warnings	Exact identifier application number: M017
Careland Pain Relief Patch Plus	LIDOCAINE	Planet (Anhui) Pharmaceutical Co., Ltd.	d55d8a9e-ed2b-4c9b-9ecb-6ec1fd43c9e3	2026-03-04	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