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
IngredientStrength
LIDOCAINE4 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98PI200987Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1291672Internal RxNorm lookup
1291677Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ca54c6da-4bf2-4e63-ba7f-a69c4f9c431aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62221-935-02Sonacaine Topical Anesthetic With Menthol60 g in 1 BOTTLEGEL604

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI200987SONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]1
LIDOCAINEACTIVE MOIETY98PI200987SONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MSONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XSONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]1
CALENDULA OFFICINALIS FLOWERINACTIVE INGREDIENTP0M7O4Y7YDSONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]1
CHAMOMILEINACTIVE INGREDIENTFGL3685T2XSONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]1
COMFREY LEAFINACTIVE INGREDIENTDG4F8T839XSONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4SONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]1
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0SONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3ASONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKSONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RSONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62221-935SONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]4Current NDC, Legacy NDC, 1 package rows20231110_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 86 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ULTRA STRENGTH ZHENG GU SHUIMENTHOL AND CAMPHORGUANGXI YULIN PHARMACEUTICAL GROUP CO LTD53397663-044d-4e48-989b-2c6257af5f842025-07-14Warnings, Adverse reactionsExact identifier
application number: M017
TIGER BALM PAIN RELIEVING HYDROGELCAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUMHaw Par Healthcare Ltd.cb60037f-bceb-4090-a5e4-bdda0cbf9f5c2025-07-14WarningsExact identifier
application number: M017
Avedana Hydrocortisone Cream with AloeHYDROCORTISONEUnipack LLC2a55c426-39b4-4d94-b6b4-6c548c9685e92025-07-13WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE ACETATERite Aid Corporationcb6e0bed-2ea1-49d2-89e7-2554e7565b742025-07-11WarningsExact identifier
application number: M017
QUALITY CHOICE Maximum Strength Lidocaine Pain Relief Roll OnLIDOCAINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION7b3ff4c1-0b60-4f7a-8aa4-c84b7c7137c42025-07-11WarningsExact identifier
application number: M017
Antibiotic Plus Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDETARGET Corporation6fba5890-f48f-4302-a8ac-5087a6e03bd52025-07-11WarningsExact identifier
application number: M017
TopCare Antibiotic Plus Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDETopco Associates LLC55dc4025-f07f-41b2-8b18-6a11ee04b5cc2025-07-11WarningsExact identifier
application number: M017
Benadryl Extra Strength Itch ReliefDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEKenvue Brands LLC309d9be0-e367-429a-a1fa-ab7855477c8a2025-07-10WarningsExact identifier
application number: M017
Bengay Vanishing ScentMENTHOL, UNSPECIFIED FORMKenvue Brands LLC6cc3294b-3b0f-44d0-af71-61db1022d2692025-07-10WarningsExact identifier
application number: M017
Cold Hot Medicated Patch 5% MentholMENTHOLQuality Choicece544a7c-8dc6-4e63-b499-d8a4e0ec48c32025-07-10WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE ACETATEWalgreen Companybff322f1-59c3-41e0-8685-fcfe52bf4b422025-07-10WarningsExact identifier
application number: M017
CVS CortisoneHYDROCORTISONECVS Pharmacy87631be8-94b8-4718-858d-d2f30e636cce2025-07-10WarningsExact identifier
application number: M017
TopCare Hydrocortisone Plus 12 MoisturizersHYDROCORTISONETopco Associates LLCc40e8e1d-d6d7-4880-99d3-011b97a5e4f32025-07-10WarningsExact identifier
application number: M017
Live Better Hydrocortisone with AloeHYDROCORTISONEThe Great Atlantic & Pacific Tea Company044e6ee2-98a6-4802-b33d-78b8551356c42025-07-10WarningsExact identifier
application number: M017
Rocainol TOPICAL ANALGESICMETHYL SALICYLATE, MENTHOLCompania Internacional de Comercio, S.A.P.I de C.V.827ec7b2-3d87-47e0-a47a-966b25732c322025-07-10WarningsExact identifier
application number: M017
NumbR-XLIDOCAINE HCLProdigy Media Inc16329ab6-4a33-4c38-85e0-5aad9c75d61d2025-07-10WarningsExact identifier
application number: M017
Dr LidoLIDOCAINE HCLProdigy Media Incda0938f0-00e7-4502-8721-d64c71f594fc2025-07-10WarningsExact identifier
application number: M017
Pain Relief PatchCAMPHOR, METHYL SALICYLATE, MENTHOLCDMA, Inc.da1ec2fe-cc37-4126-90a8-6eb4b8f2e57b2025-07-09WarningsExact identifier
application number: M017
ORTHOGEL Menthol 3.5%MENTHOLLiquidCapsule Manufacturing LLC4fd4b7ac-1971-4abe-8fbb-74ab69e120612025-07-09WarningsExact identifier
application number: M017
Good Neighbor Pharmacy Hydrocortisone Plus 12 MoisturizersHYDROCORTISONEAmerisourceBergenf36acdb8-a526-4bb7-a557-e1dcbbc1cf452025-07-08WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1291672lidocaine 4 % Topical GelPSNca54c6da-4bf2-4e63-ba7f-a69c4f9c431a4
1291677sonacaine 4 % Topical GelPSNca54c6da-4bf2-4e63-ba7f-a69c4f9c431a4
1291677lidocaine 0.04 MG/MG Topical Gel [Sonacaine]SBDca54c6da-4bf2-4e63-ba7f-a69c4f9c431a4
1291672lidocaine 0.04 MG/MG Topical GelSCDca54c6da-4bf2-4e63-ba7f-a69c4f9c431a4
1291672lidocaine 4 % Topical GelSYca54c6da-4bf2-4e63-ba7f-a69c4f9c431a4
1291677Sonacaine 0.04 MG/MG Topical GelSYca54c6da-4bf2-4e63-ba7f-a69c4f9c431a4
1291677Sonacaine 4 % Topical GelSYca54c6da-4bf2-4e63-ba7f-a69c4f9c431a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62221-935-026222109350260 g in 1 BOTTLE (62221-935-02) 60 g2012-05-020000-00-00NoNoCurrent