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 26 of 40 · 796 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Primo Topical Anesthetic	BENZOCAINE	Tri State Dental	f7862ee9-117a-493d-83ee-5aef588a86de	2025-01-08	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Primo Topical Anesthetic	BENZOCAINE	Tri State Dental	011c6a04-a489-41a5-ad2f-8ec281e07933	2025-01-08	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Primo Topical Anesthetic	BENZOCAINE	Tri State Dental	45422b0f-f1ac-4bec-851a-c1394bc52fcc	2025-01-08	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043c336f-60e3-dc23-e063-6294a90a4b13	2025-01-08	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
HurriCaine Topical Anesthetic Gel	BENZOCAINE	Beutlich Pharmaceuticals, LLC	e67b8def-c728-4952-9b35-874643cbe0f1	2025-01-08	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	e628bd9f-99e5-4c71-ba8a-caa6c337de54	2025-01-08	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
HurriCaine Topical Anesthetic Gel	BENZOCAINE	Beutlich Pharmaceuticals, LLC	fef1f48c-e89d-4b75-9ba0-b1b068daf582	2025-01-08	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Primo Topical Anesthetic	BENZOCAINE	Tri State Dental	b18c2bfc-638e-40a7-8ecb-60303aa3f519	2025-01-08	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Primo Topical Anesthetic	BENZOCAINE	Tri State Dental	64b9ebe6-afbe-4db2-b4bf-14ff5d007ea0	2025-01-08	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Primo Topical Anesthetic	BENZOCAINE	Tri State Dental	f5d37a12-9db1-4f2c-9dd1-72a8361e0e57	2025-01-08	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Primo Topical Anesthetic	BENZOCAINE	Tri State Dental	cb25c40b-07ef-44b8-9f48-0b8f3f78c882	2025-01-08	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Primo Topical Anesthetic	BENZOCAINE	Tri State Dental	3ad7867c-b584-4355-9fd7-7582919751bd	2025-01-08	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Advance Topical Anesthetic Gel	BENZOCAINE	The Atlanta Dental Supply Company DBA Advanced Dental Products	aaa7d4e2-9154-4c34-a1ec-d89231eda447	2025-01-08	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Advance Topical Anesthetic Gel	BENZOCAINE	The Atlanta Dental Supply Company DBA Advanced Dental Products	c385cc66-7d08-4b63-bfba-a133b5275c6d	2025-01-08	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Advance Topical Anesthetic Gel	BENZOCAINE	The Atlanta Dental Supply Company DBA Advanced Dental Products	ddc81125-e12b-4170-938d-df7a624a7dfd	2025-01-08	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Advance Topical Anesthetic Gel	BENZOCAINE	The Atlanta Dental Supply Company DBA Advanced Dental Products	aaa1390b-d060-43a4-87ee-1497fa82e21b	2025-01-08	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Advance Topical Anesthetic Gel	BENZOCAINE	The Atlanta Dental Supply Company DBA Advanced Dental Products	c78b5f2b-4434-4f36-82e3-781409db4162	2025-01-08	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Advance Topical Anesthetic Gel	BENZOCAINE	The Atlanta Dental Supply Company DBA Advanced Dental Products	4545ab53-aa2d-41c4-9395-50bb64c19663	2025-01-08	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
HurriCaine Topical Anesthetic Gel	BENZOCAINE	Beutlich Pharmaceuticals, LLC	c113773b-dfb0-4797-ae0e-ecc06bfffd68	2025-01-08	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
HurriCaine Topical Anesthetic Liquid	BENZOCAINE	Beutlich Pharmaceuticals, LLC	31232583-180c-43d1-bc45-c3f6d9ea5081	2025-01-08	Warnings	Exact identifier unii: U3RSY48JW5

Reported adverse events (FAERS/openFDA)#

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