FDA.reportPublic FDA data

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68400-323-35ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68400-323-35367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68400-323-35557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68400-323-358af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68400-323-35834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68400-323-351332a3947898…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
IngredientStrength
BENZOCAINE11.4 g/57g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1435490Internal RxNorm lookup
1435495Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9991de96-99a1-42f0-9ddd-e530ca9ceab1Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68400-323-352024-12-19C16284748780-11030e364-fcc0-111a-e063-dadaa90a10e29991de96-99a1-42f0-9ddd-e530ca9ceab1
68400-323-352024-01-30C16284748780-11030e364-fcc0-111a-e063-dadaa90a10e29991de96-99a1-42f0-9ddd-e530ca9ceab1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68400-323-35Gelato Topical Anesthetic57 g in 1 BOTTLE, SPRAYSPRAY, METERED577

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5GELATO TOPICAL ANESTHETIC (BENZOCAINE) SPRAY, METERED [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC]2
BENZOCAINEACTIVE MOIETYU3RSY48JW5GELATO TOPICAL ANESTHETIC (BENZOCAINE) SPRAY, METERED [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQGELATO TOPICAL ANESTHETIC (BENZOCAINE) SPRAY, METERED [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYGELATO 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
NDCDashboard titleSPL versionValidationDashboard ZIP
68400-323GELATO TOPICAL ANESTHETIC (BENZOCAINE) SPRAY, METERED [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC]7Current NDC, Legacy NDC, 1 package rows20241222_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 7 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lemon GlycerinGLYCERINDynarex Corporation99fc00ea-9d55-0380-e053-2995a90a2c0b2026-03-24WarningsExact identifier
application number: M022
Dual-FormulaToothpaste for sensitive teethDUAL-FORMULA TOOTHPASTE FOR SENSITIVE TEETHHangzhou Namei Zhikang Technology Co., Ltd.4d735f91-8abc-3a30-e063-6394a90a76392026-03-20WarningsExact identifier
application number: M022
SmileCare Mouth Ulcer GelMENTHOLYantai Aien Biotechnology Co., Ltd.4d6db039-5b97-8f3f-e063-6294a90a9d852026-03-19WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f91e609-8ca5-0492-e053-2a95a90a85d02026-03-17WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f81ffa5-05fd-4eef-e053-2995a90aac3e2026-03-17WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f947366-9380-3fa9-e053-2a95a90ad49c2026-03-17WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f947672-4873-5546-e053-2a95a90a3c4b2026-03-17WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f9490c1-8bfe-3166-e053-2a95a90a71752026-03-17WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f94b65d-47e3-9c6b-e053-2a95a90aa1f82026-03-17WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dental4d3e03ee-6e0f-c9ae-e063-6394a90a6f5b2026-03-17WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043c00a6-1346-7780-e063-6294a90a3d5a2026-03-12WarningsExact identifier
application number: M022
ORAL PAIN RELIEFBENZOCAINENantong Health & Beyond Hygienic Products Inc.a5f0be98-d47e-4307-8044-304a64db774b2026-03-11WarningsExact identifier
application number: M022
SENSODYNE PRONAMEL Intensive Enamel Repair WhiteningPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCa2f9d58b-671b-4427-a971-1fceff5f23232026-03-09WarningsExact identifier
application number: M022
Sore Mouth CleanserHYDROGEN PEROXIDECVS Pharmacy, Inc.a5dbaadf-76a8-4c48-af2d-f4455e9411f02026-03-09Warnings, Adverse reactionsExact identifier
application number: M022
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDESam's West, Inc78a3e024-73da-40b7-9d9c-099fd6ca9b9e2026-03-03WarningsExact identifier
application number: M022
Sore ThroatPHENOL GLYCERINCVS PHARMACY, INC9683bcfb-2f7e-48a4-aa79-500ee8df099a2026-03-02WarningsExact identifier
application number: M022
Spring Gene Oil Pulling SensitivityPOTASSIUM NITRATEHealth and Natural Beauty USA Corp294051e3-69ec-4190-8b03-fa34988376b72026-02-26WarningsExact identifier
application number: M022
Lolleez WatermelonPECTINBFY LLC4ba8af8b-5a17-8b8c-e063-6394a90a63f32026-02-25WarningsExact identifier
application number: M022
Oral Sore AntisepticHYDROGEN PEROXIDE, MENTHOLH E Bf1450866-1be4-46d9-9fe4-52d699636b4f2026-02-24Warnings, Adverse reactionsExact identifier
application number: M022
SIGNATURE CARE SORE THROAT CHERRY FLAVORPHENOLSAFEWAY94a2c1b9-f462-4489-b84a-825a82835d302026-02-23WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1435490benzocaine 20 % Oral SprayPSN9991de96-99a1-42f0-9ddd-e530ca9ceab17
1435495Gelato Anesthetic 20 % Oral SprayPSN9991de96-99a1-42f0-9ddd-e530ca9ceab17
1435495benzocaine 200 MG/ML Oral Spray [Gelato Anesthetic]SBD9991de96-99a1-42f0-9ddd-e530ca9ceab17
1435490benzocaine 200 MG/ML Oral SpraySCD9991de96-99a1-42f0-9ddd-e530ca9ceab17
1435490benzocaine 20 % Oral SpraySY9991de96-99a1-42f0-9ddd-e530ca9ceab17
1435495Gelato Anesthetic 20 % Oral SpraySY9991de96-99a1-42f0-9ddd-e530ca9ceab17
1435495Gelato Anesthetic 200 MG/ML Oral SpraySY9991de96-99a1-42f0-9ddd-e530ca9ceab17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68400-323-356840003233557 g in 1 BOTTLE, SPRAY (68400-323-35) 57 g2018-09-010000-00-00NoNoCurrent