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 23 of 40 · 796 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Benzocaine	TOPICAL ANESTHETIC	Everpharm LLC	2bc57111-0f15-b237-e063-6294a90a4471	2025-01-15	Warnings	Exact identifier unii: U3RSY48JW5
EVR Sting Relief Wipe	BENZOCAINE, ISOPROPYL ALCOHOL	Changzhou Maokang Medical Products Co., Ltd.	2b584d09-916c-00f8-e063-6294a90adbcf	2025-01-10	Warnings	Exact identifier unii: U3RSY48JW5
Cetacaine Anesthetic	BENZOCAINE, BUTAMBEN, AND TETRACAINE HYDROCHLORIDE	Cetylite Industries, Inc.	89f262a4-a41b-41d7-806b-61b9b89542f0	2025-01-10	Warnings	Exact identifier unii: U3RSY48JW5
Kanka Triple Action	BENZOCAINE AND MENTHOL, UNSPECIFIED FORM	Blistex Inc.	078fcdab-38a1-4a9a-bdd3-e17446591ea8	2025-01-09	Warnings	Exact identifier unii: U3RSY48JW5
Astra-dent Topical Anesthetic Gel	BENZOCAINE	Zag Usa Inc	9315bd7c-44db-42c8-a9df-aaaa66153c17	2025-01-09	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Astra-dent Topical Anesthetic Gel	BENZOCAINE	Zag Usa Inc	56185c5f-6f6c-4976-bf18-540b076d90a6	2025-01-09	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Astra-dent Topical Anesthetic Gel	BENZOCAINE	Zag Usa Inc	88cadb9e-17ab-44bb-b4fe-fcfd6b733465	2025-01-09	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Astra-dent Topical Anesthetic Gel	BENZOCAINE	Zag Usa Inc	f71b0ab5-0605-4807-b835-903e19aaf2a8	2025-01-09	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Astra-dent Topical Anesthetic Gel	BENZOCAINE	Zag Usa Inc	37e2d51d-8526-4766-9f15-0ef4bc1f1155	2025-01-09	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Astra-dent Topical Anesthetic Gel	BENZOCAINE	Zag Usa Inc	1c0770a4-5a82-46d4-a660-7553632d749b	2025-01-09	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Astra-dent Topical Anesthetic Gel	BENZOCAINE	Zag Usa Inc	f1289991-c809-48cb-8bc1-724bc233dfe9	2025-01-09	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Astra-dent Topical Anesthetic Gel	BENZOCAINE	Zag Usa Inc	f2a3a496-c9e0-4eb1-94cc-4c6c5fd60fee	2025-01-09	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Burkhart Topical Anesthetic	BENZOCAINE	Burkhart Dental Supply Inc	26128466-939b-445f-aa64-04c7283d306c	2025-01-09	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Burkhart Topical Anesthetic	BENZOCAINE	Burkhart Dental Supply Inc	aa09dcc0-e641-4c6d-8a84-ba890c0fce4c	2025-01-09	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Burkhart Topical Anesthetic	BENZOCAINE	Burkhart Dental Supply Inc	4255da05-d264-4a4c-bd67-53d4862c0682	2025-01-09	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Burkhart Topical Anesthetic	BENZOCAINE	Burkhart Dental Supply Inc	2282ea74-94c1-40be-a77f-290763a76250	2025-01-09	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Burkhart Topical Anesthetic	BENZOCAINE	Burkhart Dental Supply Inc	99bce4c6-4593-40a1-b28d-8334a79b9d42	2025-01-09	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Burkhart Topical Anesthetic	BENZOCAINE	Burkhart Dental Supply Inc	aa233c68-c6ac-44a5-b50e-3f5cd843bd25	2025-01-09	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Burkhart Topical Anesthetic	BENZOCAINE	Burkhart Dental Supply Inc	bb11bfb4-1b50-48c6-8273-452b47b47833	2025-01-09	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Burkhart Topical Anesthetic	BENZOCAINE	Burkhart Dental Supply Inc	867cef7b-fe6e-4a45-87c1-35579a681c6c	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.