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
Label	Manufacturer	Effective date	Type
Gelato Topical Anesthetic	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.	2013-11-19	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68400-504-25	2020-01-31	C162847	48780-1	9d75b9d0-2b81-f424-e053-dadaa90a57ce	2f764009-5405-4ff5-8223-12d2aedeb2ad

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68400-504-25	Gelato Topical Anesthetic	12 g in 1 JAR	GEL	12		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68400-504	GELATO TOPICAL ANESTHETIC (BENZOCAINE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]	2	1 package rows	20131207_2f764009-5405-4ff5-8223-12d2aedeb2ad.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Benzocaine	ACTIVE INGREDIENT	U3RSY48JW5	GELATO TOPICAL ANESTHETIC (BENZOCAINE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]	2
Benzocaine	ACTIVE MOIETY	U3RSY48JW5	GELATO TOPICAL ANESTHETIC (BENZOCAINE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]	2
Polyethylene Glycol 3350	INACTIVE INGREDIENT	G2M7P15E5P	GELATO TOPICAL ANESTHETIC (BENZOCAINE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]	2
Polyethylene Glycol 400	INACTIVE INGREDIENT	B697894SGQ	GELATO TOPICAL ANESTHETIC (BENZOCAINE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]	2
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	GELATO 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 24 of 40 · 796 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Burkhart Topical Anesthetic	BENZOCAINE	Burkhart Dental Supply Inc	c6238079-0bcc-4c35-9b73-455252d41ee5	2025-01-09	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Burkhart Topical Anesthetic	BENZOCAINE	Burkhart Dental Supply Inc	b144aca9-91d1-4106-a39c-b928192ad41e	2025-01-09	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Candee Caine Topical Anesthetic	BENZOCAINE	American Medical & Hospital Supply Co., Inc.	0192ccf9-1715-4e23-a6bf-8bd838cd8b0d	2025-01-09	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Candee Caine Topical Anesthetic	BENZOCAINE	American Medical & Hospital Supply Co., Inc.	edcb8451-6fa7-4bc2-95f6-2a0806f7f3da	2025-01-09	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Candee Caine Topical Anesthetic	BENZOCAINE	American Medical & Hospital Supply Co., Inc.	576660ed-203a-4842-9d39-c5be10daf976	2025-01-09	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Candee Caine Topical Anesthetic	BENZOCAINE	American Medical & Hospital Supply Co., Inc.	1796b3ec-833a-4cf1-ba50-bc4da827f84f	2025-01-09	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Candee Caine Topical Anesthetic	BENZOCAINE	American Medical & Hospital Supply Co., Inc.	d923fa75-f556-45e3-9f52-39a62e89984b	2025-01-09	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Candee Caine Topical Anesthetic	BENZOCAINE	American Medical & Hospital Supply Co., Inc.	cd3ede8c-2c77-4d81-8dff-8198025a2156	2025-01-09	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	a225d515-430d-4e34-846c-0bfec3e74109	2025-01-09	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	372f99c9-4ad3-4631-b8c8-2a34c47343cc	2025-01-09	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	e554b5b2-cf91-464a-a930-3e1087f12c8d	2025-01-09	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	98da331c-76c2-49fe-b687-6bfba4ae2e75	2025-01-09	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	d2195efa-597d-4ba9-a9b0-8df0d8f49311	2025-01-09	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	fba82d55-94db-4432-b532-603fe57202be	2025-01-09	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	9ed0fe31-e5f2-4d6d-8686-1286c6659847	2025-01-09	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	d5f42c30-343c-4e1d-950c-89bbd361fd27	2025-01-09	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Dental City Topical Anesthetic	BENZOCAINE	ICP Inc DBA Dental City	7dce407f-bbe4-4a27-97ff-be33fd447461	2025-01-09	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
GPS Topical Anesthetic	BENZOCAINE	Group Practice Solutions, Inc.	921bdb76-f6d3-4e0a-a0ac-277dcc4e8d28	2025-01-09	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
GPS Topical Anesthetic	BENZOCAINE	Group Practice Solutions, Inc.	a80cfd29-8314-4639-a811-afd5fdb630b0	2025-01-09	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
GPS Topical Anesthetic	BENZOCAINE	Group Practice Solutions, Inc.	69271b7a-18c0-4445-8164-cb1620fb5475	2025-01-09	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5

Reported adverse events (FAERS/openFDA)#

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