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 26 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dr Sabharwals	LIDOCAINE 4% GEL PATCH	Dr. Sabharwal's Wound Care	102399b6-5be9-ee5e-e063-6394a90a3198	2026-04-02	Warnings	Exact identifier application number: M017
TATTOO NUMBX NUMBING PAIN RELIEVING	LIDOCAINE HYDROCHLORIDE	Scyberco Ltd	ac8eac04-ed5b-4c8e-9f9b-54d160b74606	2026-04-02	Warnings	Exact identifier application number: M017
FifthPulse Hydrocortisone	HYDROCORTISONE	WeCare Products LLC	f1fcb045-4a15-431b-9617-67eae9f87fbd	2026-04-02	Warnings	Exact identifier application number: M017
ANIXIKE Cream	MENTHOL 5% CREAM	Jiangxi Yudexi Pharmaceutical Co., LTD	4e8510e6-c0c7-bf6b-e063-6294a90a3b00	2026-04-02	Warnings	Exact identifier application number: M017
RAPID RELIEF	0.025% CAPSAICIN PAIN PATCH	83569	4ed549e8-0062-fb03-e063-6294a90aac65	2026-04-02	Warnings	Exact identifier application number: M017
Itch Relief	DIPHENHYDRAMINE HCL AND ZINC ACETATE	CVS Pharmacy	7e921988-ec66-38dc-e053-2a91aa0a7346	2026-04-01	Warnings	Exact identifier application number: M017
The Best Numbing Cream	TBNC	The Best Numbing Cream LLC	4ca3923b-f586-0aaf-e063-6294a90a16c1	2026-03-31	Warnings	Exact identifier application number: M017
ChapStick Classic Medicated	EXTERNAL ANALGESIC AND SKIN PROTECTANT LIP BALM	Suave Brands Co., LLC	42798a6c-2d7e-80f6-e063-6294a90a105f	2026-03-31	Warnings	Exact identifier application number: M017
Roll-On Pain Relief Liquid	LIDOCAINE HCL	HyVee Inc	4da6f6fb-b182-360f-e063-6294a90abdf3	2026-03-31	Warnings	Exact identifier application number: M017
Hand Sanitizer	ALCOHOL	ProStat First Aid	4e54aecb-190f-3866-e063-6294a90a810a	2026-03-31	Warnings	Exact identifier application number: M017
Burn Mist	LIDOCAINE HYDROCHLORIDE	Water-Jel Technologies	c53ab9dd-351a-400b-b873-4f396e0af54d	2026-03-31	Warnings	Exact identifier application number: M017
Satohap Lidocaine Hydrochloride 4 Percent Pain Relieving	LIDOCAINE HYDROCHLORIDE	Sato Pharmaceutical Co., Ltd.	f7faddb2-5153-4fdd-a5ef-778182cef460	2026-03-31	Warnings	Exact identifier application number: M017
ZENOL COOL	METHYL SALICYLATE, L-MENTHOL	BA TRADE INC	4e5c45f4-88ce-3a13-e063-6394a90a2a09	2026-03-31	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Roll On Refresh	CAMPHOR, MENTHOL	Borden Company (Private) Limited	091451fb-e30a-0012-e063-6394a90a3ba8	2026-03-31	Warnings	Exact identifier application number: M017
Icy Hot Revive and Recovery Pain Relief No- Mess Roll On Refreshing Lime and Mint	MENTHOL	Chattem, Inc.	b16ba9c2-23bf-4fdf-b44b-7abb9fec1911	2026-03-31	Warnings	Exact identifier application number: M017
DR.PABU NUMBING	LIDOCAINE 5% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4e3a3c6c-4821-76ea-e063-6294a90a8f96	2026-03-30	Warnings	Exact identifier application number: M017
Doctor Jiao Antifungal Cream	MICONAZOLE NITRATE	Jiangxi Haiwei Pharmaceutical Co., Ltd.	4e3b231e-0642-bf63-e063-6394a90a905b	2026-03-30	Warnings	Exact identifier application number: M017
CVS Muscle Balm and Roll-On	CAMPHOR, MENTHOL	CVS Pharmacy	4e40025a-070a-508e-e063-6394a90af5d7	2026-03-30	Warnings	Exact identifier application number: M017
REGENECARE HA	LIDOCAINE HCL	MPM Medical LLC	c3eec066-38e8-4617-b34d-2f72ffb7a324	2026-03-30	Warnings	Exact identifier application number: M017
Softlips Naturals Medicated Matcha Honey	CAMPHOR, MENTHOL	The Mentholatum Company	4e03a721-73f3-b2f2-e063-6394a90a44e6	2026-03-27	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