FDA.reportPublic FDA data

NDC 68400-504 - Gelato Topical Anesthetic

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68400-504
Package NDCs from labels
68400-504-25
Manufacturer
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.
Effective date
2013-11-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Gelato Topical AnestheticMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.2013-11-19HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68400-504-252020-01-31C16284748780-19d75b9d0-2b81-f424-e053-dadaa90a57ce2f764009-5405-4ff5-8223-12d2aedeb2ad

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68400-504-25Gelato Topical Anesthetic12 g in 1 JARGEL122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68400-504GELATO TOPICAL ANESTHETIC (BENZOCAINE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]21 package rows20131207_2f764009-5405-4ff5-8223-12d2aedeb2ad.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BenzocaineACTIVE INGREDIENTU3RSY48JW5GELATO TOPICAL ANESTHETIC (BENZOCAINE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]2
BenzocaineACTIVE MOIETYU3RSY48JW5GELATO TOPICAL ANESTHETIC (BENZOCAINE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]2
Polyethylene Glycol 3350INACTIVE INGREDIENTG2M7P15E5PGELATO TOPICAL ANESTHETIC (BENZOCAINE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]2
Polyethylene Glycol 400INACTIVE INGREDIENTB697894SGQGELATO TOPICAL ANESTHETIC (BENZOCAINE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]2
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TYGELATO TOPICAL ANESTHETIC (BENZOCAINE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]2

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 37 of 40 · 796 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC0b51b67c-03ac-5730-e063-6394a90a50602023-11-29WarningsExact identifier
rxcui: 238910
unii: U3RSY48JW5
HIGHER CONTROL Male Climax Control LubricatingBENZOCAINEProduct Max Group Inc5f5fd127-34c5-403a-aa95-c9874ae794922023-11-10WarningsExact identifier
unii: U3RSY48JW5
BODY ACTION PRODUCTS Prolong LubricatingBENZOCAINEPRODUCT MAX GROUP INC3bef5915-1c98-4011-baa9-ad0bbef200c22023-11-10WarningsExact identifier
unii: U3RSY48JW5
BODY ACTION PRODUCTS Climax Control GelBENZOCAINEPRODUCT MAX GROUP INC53e746cc-0078-4381-bf0b-9c8f98d669042023-11-10WarningsExact identifier
unii: U3RSY48JW5
BODY ACTION PRODUCTS Endless Love for MenBENZOCAINEPRODUCT MAX GROUP INCd0fa792d-dc04-4bdf-a22d-dea896beae5b2023-11-10WarningsExact identifier
unii: U3RSY48JW5
Endless Love For MenBENZOCAINEBody Action Products, Inc4e89cd3a-ecad-44c3-acb3-6d0810add8c02023-11-10WarningsExact identifier
unii: U3RSY48JW5
BODY ACTION PRODUCTS Butt Eze BenzocaineBENZOCAINEPRODUCT MAX GROUP INCba75b129-7939-4373-91f5-1772976e6d612023-11-10WarningsExact identifier
unii: U3RSY48JW5
BODY ACTION PRODUCTS Higher Control Male ClimaxBENZOCAINEPRODUCT MAX GROUP INC3c7fa73b-abe8-4a8d-951c-4e785d6e812c2023-11-10WarningsExact identifier
unii: U3RSY48JW5
Welby ClearLaxPOLYETHYLENE GLYCOL 3350Aldi, Incd64caba5-614f-4edc-bb47-ce4fed38ce452023-11-10WarningsExact identifier
unii: G2M7P15E5P
MK Sting Relief PadsBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd1a60dd1b-0116-42a2-a501-4f74e326a2e92023-11-09WarningsExact identifier
unii: U3RSY48JW5
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC33fbdbc7-e10d-4181-926f-9b591b5b07e32023-11-08WarningsExact identifier
rxcui: 238910
unii: U3RSY48JW5
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC0d2c8c0c-4c72-4400-b3b5-ed578fa351672023-11-08WarningsExact identifier
rxcui: 238910
unii: U3RSY48JW5
Hims Delay WipesBENZOCAINE WIPESHims Inc.adbead3d-dca0-4919-b688-44c88f779e5a2023-11-07WarningsExact identifier
unii: U3RSY48JW5
INTIMALE Benzocaine Delay GelBENZOCAINESKINS SEXUAL HEALTH LIMITEDb845bfd5-ab73-495f-97ef-e959bc6311d92023-11-06WarningsExact identifier
unii: U3RSY48JW5
Oral Pain ReliefBENZOCAINEGERI-CARE PHARMACEUTICAL CORPd294a39e-55f4-272d-e053-2995a90ab7f72023-10-31WarningsExact identifier
rxcui: 238910
unii: U3RSY48JW5
Family WellnessBENZOCAINE, RESORCINOLZhejiang Jingwei Pharmaceutic Al Co., Ltd.df540eb8-6773-4647-9cc2-c3fd14d7355e2023-10-27WarningsExact identifier
unii: U3RSY48JW5
CARMEX Multi-Symptom 3 in 1 COLD Sore treatment External Analgesic Skin ProtectantBENZOCAINE, WHITE PETROLATUMCarma Laboratories, Inc.bbf0abcd-b7d6-b5e4-e053-2995a90a52402023-10-25WarningsExact identifier
unii: U3RSY48JW5
Sting ReliefBENZOCAINE, ISOPROPYL ALCOHOLJianerkang Medical Co., Ltd3a32398a-3f7e-4da0-bb1d-b3f369914b2a2023-10-23WarningsExact identifier
unii: U3RSY48JW5
DUKAL STING RELIEF PADBENZOCAINEDukal LLC67c1ddc7-8fde-4431-84cb-f757682d5f3e2023-10-13WarningsExact identifier
unii: U3RSY48JW5
AvantBENZOCAINEDharma Research, Inc.e10c45e6-d37f-4650-b3e5-07719cc0ea492023-10-11WarningsExact identifier
unii: U3RSY48JW5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.