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 4 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MAXIMUM STRENGTH Lidocaine Plus MentholLIDOCAINE, MENTHOLARMY AND AIR FORCE EXCHANGE SERVICE60f72061-d264-424e-b396-5a609076d3522026-08-20WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET PAIN RELIEF5980c527-6bcb-a846-e063-6294a90a07882026-08-20WarningsExact identifier
application number: M017
Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEAmerisource Bergen5fb5e5ce-b268-4444-8b63-ea7ea6abf2692026-08-20WarningsExact identifier
application number: M017
Dr. Scholls Blister Pain Relief Complete KitLIDOCAINEScholl's Wellness Company LLC58c2b35c-e1ed-7ea8-e063-6294a90a14942026-08-19WarningsExact identifier
application number: M017
Dr. Scholls Blister Pain Relief Complete KitLIDOCAINEScholl's Wellness Company LLC585e740b-e4fa-d2aa-e063-6294a90a09822026-08-19WarningsExact identifier
application number: M017
Eagle Brand Muscular BalmMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA0822bcde-a8ad-be95-e063-6294a90ad2082026-08-19WarningsExact identifier
application number: M017
ANTI ITCHHYDROCORTISONEHyVee Inc1ab6bbb8-2b91-4c53-9168-b1e85ac296e92026-08-19WarningsExact identifier
application number: M017
hydrocortisone 1HYDROCORTISONEKroger Companyf05edff2-2dc5-427c-b52c-518e0aaef4e02026-08-19WarningsExact identifier
application number: M017
MedPrideHYDROCORTISONEShield Line LLC2f15d3b3-d1e6-4742-9eac-f956c0ffbba42026-08-18WarningsExact identifier
application number: M017
Pain Relieving Cream AnalgesicMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATEGarcoa, Inc.2f736307-5cd4-4a76-9044-4aeecba096cc2026-08-18WarningsExact identifier
application number: M017
Lidocaine Pain Relief Roll onPAIN RELIEF ROLL ONNeilMed Pharmaceuticals Inc58ff9d2d-99e6-8f98-e063-6394a90a8de72026-08-17WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONE CREAM 1/2%Sun Pharmaceutical Industries, Inc.59337940-c9be-58af-e063-6394a90abe132026-08-16WarningsExact identifier
application number: M017
SIERQ NumbingMENTHOLPutian Licheng District Zhijiancheng Trading Co., Ltd.5936c070-d8e4-56e8-e063-6294a90a56002026-08-16WarningsExact identifier
application number: M017
Jakwork Numbing CreamNUMBING CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5911d9b0-1acb-3546-e063-6294a90adb3a2026-08-15WarningsExact identifier
application number: M017
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology59072f05-eefa-d823-e063-6394a90a0e1a2026-08-14WarningsExact identifier
application number: M017
JJ Care First Aid BurnBENZALKONIUM CHLORIDE, LIDOCAINE HCINantong Health & Beyond Hygienic Products Inc.c41621fb-c549-4394-a4cb-cb81ef8c98df2026-08-13WarningsExact identifier
application number: M017
JJ CareHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.c88fa151-f8a8-4de2-98c9-71319bf53e362026-08-13WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONESafetec of America, Inc.da2b3b2c-11e0-401b-bbd2-d019271d1b3d2026-08-13WarningsExact identifier
application number: M017
CVS Pain Relief Roll-On Lidocaine with LavenderLIDOCAINE HYDROCHLORIDECVS Pharmacy4aa53176-2103-b47b-e063-6394a90ac7352026-08-12WarningsExact identifier
application number: M017
JUST CBD SOOTHINGMENTHOL, CAMPHORJust Brands LLC5384e80f-c242-76a1-e063-6294a90aba0b2026-08-12WarningsExact 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