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 29 of 40 · 796 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dental72fd2232-cd5a-4e25-b139-522b589c44722025-01-08WarningsExact identifier
rxcui: 238910
unii: U3RSY48JW5
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC42521b29-67e4-4a16-848d-7e6ba4a7ece22025-01-08WarningsExact identifier
rxcui: 238910
unii: U3RSY48JW5
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals LLC723da3ae-3f1f-4962-920b-f2a30c8c32532025-01-08Warnings, Adverse reactionsExact identifier
rxcui: 238910
unii: U3RSY48JW5
Sting Relief SwabBENZOCAINEEpic Medical Supply Corp259fbfe4-d67c-ea1e-e063-6294a90a0fb02025-01-07WarningsExact identifier
unii: U3RSY48JW5
Benzo-JelBENZOCAINEHenry Schein Inc.bc2e7ac3-f9e4-49cc-9f0c-6fe94479314d2025-01-03WarningsExact identifier
rxcui: 238910
unii: U3RSY48JW5
Benzo-JelBENZOCAINEHenry Schein Inc.fb38b10d-0faf-403c-9921-d4f6b0f6aa552025-01-03WarningsExact identifier
rxcui: 238910
unii: U3RSY48JW5
Benzo-JelBENZOCAINEHenry Schein Inc.a9dc2245-c029-4453-bfc5-8fb899873c342025-01-03WarningsExact identifier
rxcui: 238910
unii: U3RSY48JW5
Benzo-JelBENZOCAINEHenry Schein Inc.ba49a18d-8568-421b-a495-8fee863c97572025-01-03WarningsExact identifier
rxcui: 238910
unii: U3RSY48JW5
Benzo-JelBENZOCAINEHenry Schein Inc.c9b584d9-7407-445a-b084-926250af9f8e2025-01-03WarningsExact identifier
rxcui: 238910
unii: U3RSY48JW5
Benzo-JelBENZOCAINEHenry Schein Inc.4aa6eec8-394a-4ecb-8173-66561fd649132025-01-03WarningsExact identifier
rxcui: 238910
unii: U3RSY48JW5
Benzo-JelBENZOCAINEHenry Schein Inc.25c99ae3-90f4-4a63-924d-f810b3ba6e602025-01-03WarningsExact identifier
rxcui: 238910
unii: U3RSY48JW5
Benzo-JelBENZOCAINEHenry Schein Inc.84e8d5c8-2a35-4179-9a9c-9a4a52c2cae62025-01-03WarningsExact identifier
rxcui: 238910
unii: U3RSY48JW5
Rite Aid Hydration Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLRite Aid Corporationecac1351-e944-21da-e053-2995a90a6d342024-12-31WarningsExact identifier
unii: B697894SGQ
BiteMD External Analgesic First Aid AntisepticBENZOCAINE, CAMPHOR (SYNTHETIC), AND PHENOLUnited Industries Corporation4c60db03-6d2b-4ae0-a200-718b3a50eb0f2024-12-23WarningsExact identifier
unii: U3RSY48JW5
Glitch Advanced Relief Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCLMisemer Pharmaceutical, Inc03778509-3374-2168-e063-6294a90a95052024-12-23WarningsExact identifier
unii: B697894SGQ
Mirakel Pain and Itch ReliefBENZOCAINE 20%, RESORCINOL 3%Sanvio, Inc.ed34d728-0275-e209-e053-2995a90a93ff2024-12-20WarningsExact identifier
unii: U3RSY48JW5
Oral Gel Oral Pain ReliefBENZOCAINE BENZALKONIUM CHLORIDESavvy Care and Cosmetics05ede7e4-5a0a-c942-e063-6294a90a8a242024-12-19WarningsExact identifier
unii: U3RSY48JW5
Pain, Burn, and Itch ReliefBENZOCAINE 20%, MENTHOL 0.5%Derma Care Research Labs, LLCfd9fe09f-3ae9-c5f5-e053-6394a90ad6912024-12-19WarningsExact identifier
unii: U3RSY48JW5
Red Cross Oral Pain ReliefBENZOCAINEThe Mentholatum Companycbd41429-f730-4577-9f06-ef1831cf62e12024-12-17WarningsExact identifier
unii: U3RSY48JW5
Red Cross Canker SoreBENZOCAINEThe Mentholatum Company54cfff96-6665-4b36-a15d-10bf6cf3a1f92024-12-17WarningsExact identifier
unii: U3RSY48JW5

Reported adverse events (FAERS/openFDA)#

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