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 92 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bliss Republic Lidocaine Numbing Cream	LIDOCAINE NUMBING CREAM	Sargass Group Limited Liability Company	35415851-beba-5bb4-e063-6294a90a35c0	2025-05-16	Warnings	Exact identifier application number: M017
Cold Hot Chinese Red Tiger Pain Relief Gel Roll-On	MENTHOL	Guangzhou Zhupuyou E-commerce Co., Ltd	352798e1-1e09-3d47-e063-6394a90ad404	2025-05-15	Warnings	Exact identifier application number: M017
Plantar Fasciitis Chinese Red Tiger Pain Relief Gel Roll-On	MENTHOL	Guangzhou Zhupuyou E-commerce Co., Ltd	35285d62-c660-a056-e063-6294a90aabc8	2025-05-15	Warnings	Exact identifier application number: M017
SionBiotext Hydrocortisone	HYDROCORTISONE ACETATE 1%	Sion Biotext Medical Ltd	35073eae-26fe-2bb5-e063-6294a90ab56a	2025-05-13	Warnings	Exact identifier application number: M017
Bliss Republic Lidocaine Numbing Cream	LIDOCAINE NUMBING CREAM	Sargass Group Limited Liability Company	3508ae14-d9c9-3c85-e063-6294a90a0098	2025-05-13	Warnings	Exact identifier application number: M017
SORE NO MORE WARM THERAPY	MENTHOL AND CAMPHOR	SOMBRA COSMETICS INC.	cd86b56e-9b4c-4aca-9740-c8793cb12055	2025-05-12	Warnings	Exact identifier application number: M017
SORE NO MORE COOL THERAPY	MENTHOL	SOMBRA COSMETICS INC.	9aa1f0ac-3baf-4e45-9e3a-c28a99b22909	2025-05-12	Warnings	Exact identifier application number: M017
Calm and Correct Serum with Lidocaine	LIDOCAINE 3 PERCENT	Renu Laboratories, LLC	ddcf1c2e-2f67-44d7-e053-2a95a90a812b	2025-05-09	Warnings	Exact identifier application number: M017
Mqupin Knee Patch	KNEE PATCH	Zhengzhou Miaoqi Pharmaceutical Technology Co., Ltd	09772e4b-8193-3771-e063-6394a90a9516	2025-05-08	Warnings	Exact identifier application number: M017
Hydrocortisone Cream	HYDROCORTISONE	Trifecta Pharmaceuticals USA	d57a59fb-c8f2-f73b-e053-2995a90a4cdb	2025-05-08	Warnings	Exact identifier application number: M017
Hydrocortisone Cream	HYDROCORTISONE	Trifecta Pharmaceuticals USA	4c96ec41-841c-322b-e054-00144ff8d46c	2025-05-08	Warnings	Exact identifier application number: M017
GNP Extra Strength Anti-Itch Cream	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Amerisource Bergen	34a66224-ef3c-e36e-e063-6394a90ac99d	2025-05-08	Warnings	Exact identifier application number: M017
Good Neighbor Muscle Rub Cream	CAMPHOR 4.0%, MENTHOL 10.0%, METHYL SALICYLATE 30.0%,	Amerisource Bergen	34924bb9-e3e8-70e6-e063-6294a90aaa8c	2025-05-07	Warnings	Exact identifier application number: M017
DermaRad Relief Post Radiation Calming	LIDOCAINE 3 PERCENT	Renu Laboratories, LLC	e5d64929-fb9c-7ebc-e053-2995a90a9318	2025-05-07	Warnings	Exact identifier application number: M017
Cold Hot Medicated Patch 5% Menthol	MENTHOL	InterMed Laboratories Private Limited	33ee0235-5a6e-0ea1-e063-6394a90a89a5	2025-05-06	Warnings	Exact identifier application number: M017
DermaRad Relief	LIDOCAINE EMULSION	RENU LABORATORIES, LLC	d5e11f73-918b-eeac-e053-2995a90a4a83	2025-05-06	Warnings	Exact identifier application number: M017
Plantar Fasciitis Pain Relief Gel-Patch	LIDOCAINE, MENTHOL	Guangzhou Zhupuyou E-commerce Co., Ltd	34838622-b092-afeb-e063-6294a90ae7db	2025-05-06	Warnings	Exact identifier application number: M017
Climax Shield Delay	BENZOCAINE	PRODUCT MAX GROUP INC	9c720cdc-f753-47ce-95ff-3b26e461a0ab	2025-05-05	Warnings	Exact identifier application number: M017
PediFix Lidocaine Pain-Relief Patches	LIDOCAINE PAIN-RELIEF PATCHES	PediFix, Inc	346550b9-d2ba-184e-e063-6394a90a591a	2025-05-05	Warnings	Exact identifier application number: M017
Walgreens Stop Itch Gel	DIPHENHYDRAMINE HCL	Walgreens Co	23586336-8f46-3dcd-e063-6394a90accc9	2025-05-04	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