Home NDC 68400-323 Gelato Topical Anesthetic
Product NDC 68400-323
11-digit product format 684000323
Labeler code 68400
Product ID 68400-323_15d7eb39-c284-291a-e063-6294a90adc6a
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine
Dosage form SPRAY, METERED
Route DENTAL
Labeler Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-07-29
Substance BENZOCAINE
Active strength 11.4 g/57g
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68400-323-35 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68400-323-35 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68400-323-35 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68400-323-35 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68400-323-35 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68400-323-35 1332a3947898…d4bfe170f9cd…
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 Gelato Topical Anesthetic
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 11.4 g/57g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3RSY48JW5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1435490 Internal RxNorm lookup 1435495 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68400-323-35 Gelato Topical Anesthetic 57 g in 1 BOTTLE, SPRAY SPRAY, METERED 57 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BENZOCAINE ACTIVE INGREDIENT U3RSY48JW5 GELATO TOPICAL ANESTHETIC (BENZOCAINE) SPRAY, METERED [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC] 2 BENZOCAINE ACTIVE MOIETY U3RSY48JW5 GELATO TOPICAL ANESTHETIC (BENZOCAINE) SPRAY, METERED [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC] 2 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ GELATO TOPICAL ANESTHETIC (BENZOCAINE) SPRAY, METERED [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC] 2 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY GELATO TOPICAL ANESTHETIC (BENZOCAINE) SPRAY, METERED [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68400-323 GELATO TOPICAL ANESTHETIC (BENZOCAINE) SPRAY, METERED [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC] 7 Current NDC, Legacy NDC, 1 package rows 20241222_9991de96-99a1-42f0-9ddd-e530ca9ceab1.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 16 of 40 · 786 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join GuruNanda Oxyfusion HYDROGEN PEROXIDE GURUNANDA, LLC 3be317b9-a5d8-b198-e063-6394a90af985 2025-11-11 Warnings Exact identifier application number: M022 GuruNanda Oral Pain Relief MENTHOL GURUNANDA, LLC 3b8f3562-0e46-bea4-e063-6294a90adb71 2025-11-11 Warnings Exact identifier application number: M022 TopCare Cherry Flavor PHENOL TOPCO ASSOCIATES, LLC 5d3f0610-deb4-4180-ae19-2c65ed2f368b 2025-11-10 Warnings Exact identifier application number: M022 Topcare Sore Throat Menthol Flavor PHENOL TOPCO ASSOCIATES LLC fb1f2c11-2508-4985-bae5-7d547bd6aa23 2025-11-10 Warnings Exact identifier application number: M022 Zilactin-B BENZOCAINE ASCENT CONSUMER PRODUCTS, INC 42eeb3d4-bac6-4e29-e063-6294a90a644d 2025-11-06 Warnings Exact identifier application number: M022 Zilactin Early Relief Cold Sore BENZYL ALCOHOL ASCENT CONSUMER PRODUCTS, INC 42ef8bfa-c4d9-01cf-e063-6394a90ac88a 2025-11-06 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic Gel BENZOCAINE Beutlich Pharmaceuticals, LLC 106b6115-d043-4050-80c6-1d82456dea02 2025-11-06 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic Gel BENZOCAINE Beutlich Pharmaceuticals, LLC 4c278122-2643-46bf-9e44-11985210a16e 2025-11-06 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic Liquid BENZOCAINE Beutlich Pharmaceuticals, LLC fee9969d-ad1a-4f44-9741-a0a44c9e1128 2025-11-06 Warnings Exact identifier application number: M022 Ear Wax Removal Aid Drops CARBAMIDE PEROXIDE Target Corporation 0ddf9945-147d-4b25-98a6-4e9f12a4656f 2025-11-05 Warnings Exact identifier application number: M022 Alpha-Caine Topical Anesthetic BENZOCAINE Dental Technologies, Inc. e6a312e5-17ac-46f0-8723-4e40eeecd69f 2025-11-04 Warnings Exact identifier application number: M022 PEROXY SHIELD MOUTH SORE 1.5% HYDROGEN PEROXIDE Dental Technologies, Inc. a72e433b-1b7d-4a0c-e053-2995a90a30c4 2025-11-04 Warnings Exact identifier application number: M022 Alpha-Caine Topical Anesthetic BENZOCAINE Dental Technologies, Inc. ae628766-25b7-4b4f-abb8-a43faf2f44b9 2025-11-04 Warnings Exact identifier application number: M022 Alpha-Caine Topical Anesthetic BENZOCAINE Dental Technologies, Inc. 719743f9-21fc-4568-b879-acdfa4639464 2025-11-04 Warnings Exact identifier application number: M022 Alpha-Caine Topical Anesthetic BENZOCAINE Dental Technologies, Inc. ff0695a1-1d7d-4b51-97fd-689e56d914fe 2025-11-04 Warnings Exact identifier application number: M022 Antiseptic EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL Family Dollar (FAMILY WELLNESS) f7edf75c-cdba-4dde-bfc5-a04af34759d3 2025-11-03 Warnings Exact identifier application number: M022 7 Select Oral Pain Maximum Strength Relief BENZOCAINE 7-ELEVEN, INC. f170a570-1c50-4b9a-be16-9b01bf5eaa74 2025-10-31 Warnings Exact identifier application number: M022 Oral Pain Relief BENZOCAINE AND BENZALKONIUM CHLORIDE Universal Distribution Center LLC 18520f9b-4d35-1e9c-e063-6294a90aaa39 2025-10-30 Warnings Exact identifier application number: M022 Iodent Oral Analgesic BENZOCAINE United Exchange Corp. 63902125-f8dc-0ada-e053-2991aa0a7ce5 2025-10-30 Warnings Exact identifier application number: M022 Ear Wax Removal Aid Drops CARBAMIDE PEROXIDE BETTER LIVING BRANDS, LLC 3bded237-4d2c-4b38-bedc-267fdc374194 2025-10-29 Warnings Exact identifier application number: M022
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 68400-323-35 68400032335 57 g in 1 BOTTLE, SPRAY (68400-323-35) 57 g 2018-09-01 0000-00-00 No No Current