Home NDC 62221-935 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.
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 Uploaded 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 18 of 153 · 3,057 matching rows.
DailyMed RxNorm Mappings# 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