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 93 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
WaxRx EarAcheRx Pain Relieving Drops	4% LIDOCAINE HCL	DOCTOR EASY MEDICAL PRODUCTS, LLC	34156655-8706-f0a4-e063-6294a90acc90	2025-05-01	Warnings	Exact identifier application number: M017
foster and thrive anti itch cream	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Strategic Sourcing Services LLC	bb08293d-5db8-4cc8-9fe3-bd02061dbeb9	2025-04-30	Warnings	Exact identifier application number: M017
Maximum Strength 4% Lidocaine Patch	LIDOCAINE	Solis Pharmaceuticals Inc.	3061d301-2104-b1b2-e063-6394a90a9b6e	2025-04-29	Warnings	Exact identifier application number: M017
Maximum Strength 4% Lidocaine Patch	LIDOCAINE	InterMed Laboratories Private Limited	33ed754e-8852-d5b2-e063-6394a90a7cf2	2025-04-29	Warnings	Exact identifier application number: M017
Cold Hot Medicated Patch 5% Menthol	MENTHOL	InterMed Laboratories Private Limited	33ee6e48-243e-4ded-e063-6394a90a987d	2025-04-29	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	32b96689-8e9b-4c2e-e063-6294a90a7d1c	2025-04-29	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	3304e362-dcda-3f5e-e063-6294a90a7015	2025-04-29	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	2f2f753d-c791-e863-e063-6394a90aec5d	2025-04-29	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	3162c96a-061d-2971-e063-6394a90a9b74	2025-04-29	Warnings	Exact identifier application number: M017
Ivarest Poison Ivy Removal and Itch Relief	PRAMOXINE HYDROCHLORIDE	Blistex Inc.	dedbf5d9-0f86-4f32-8321-da86c9838c0a	2025-04-29	Warnings	Exact identifier application number: M017
HealthWise 2X Medicated Pain Relief Cream Roll-on	MENTHOL	Veridian Healthcare	33dae8a8-4197-f276-e063-6294a90aea83	2025-04-28	Warnings	Exact identifier application number: M017
HealthWise Roll-on Menthol Pain Relief Gel	MENTHOL	Veridian Healthcare	33dbb939-9397-7e70-e063-6294a90ac8f4	2025-04-28	Warnings	Exact identifier application number: M017
Stopain Extra Strength Gel	MENTHOL	Troy Manufacturing, Inc.	fa1a98bc-c233-410d-a20e-71111c897372	2025-04-28	Warnings	Exact identifier application number: M017
Lidocaine Patch 4%	LIDOCAINE 4%	Medcore LLC	b961906c-fe66-466b-af2c-072781fa098b	2025-04-28	Warnings	Exact identifier application number: M017
Walgreens Lidocaine Knee and Elbow	LIDOCAINE	Walgreen Co.	a3fb4c78-1493-4ba4-ae83-502dd825ed67	2025-04-25	Warnings	Exact identifier application number: M017
Walgreens Lidocaine Back	LIDOCAINE	Walgreen Co.	e6bfd342-c0db-46b9-b5e6-5acbd860adf1	2025-04-25	Warnings	Exact identifier application number: M017
Electrum Numb Foam	LIDOCAINE HCI	RENU LABORATORIES, LLC	c8472932-28b7-9189-e053-2a95a90a44df	2025-04-25	Warnings	Exact identifier application number: M017
Benadryl Extra Strength Itch Stopping	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	66a2fd60-1757-45cc-a195-ecb9241dca2a	2025-04-24	Warnings	Exact identifier application number: M017
Jakwork Numbing Cream	NUMBING CREAM	Guangzhou Zanming Trading Co., Ltd.	3385cddb-609f-62e8-e063-6294a90add81	2025-04-24	Warnings	Exact identifier application number: M017
PICKLEBALM LIDOCAINE WITH MENTHOL ARNICA CUCUMBER SEED	LIDOCAINE, MENTHOL	Compass Health Brands Corp.	2bd8aae0-2606-c7f2-e063-6294a90a9a20	2025-04-22	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