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 22 of 40 · 796 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pearson Topical Anesthetic	BENZOCAINE	Pearson Dental Supplies INC.	9c6a26e8-1253-49f7-9ce2-45c0d39f05c5	2025-01-16	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Pearson Topical Anesthetic	BENZOCAINE	Pearson Dental Supplies INC.	48178733-7433-41ec-b178-1314e0edab1a	2025-01-16	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Pearson Topical Anesthetic	BENZOCAINE	Pearson Dental Supplies INC.	af430cf4-f1b4-4b57-b8e3-87df96d655d3	2025-01-16	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Pearson Topical Anesthetic	BENZOCAINE	Pearson Dental Supplies INC.	2b089fec-cae3-4dc9-964d-d37f732a2f9f	2025-01-16	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Pearson Topical Anesthetic	BENZOCAINE	Pearson Dental Supplies INC.	6c137a93-4a34-4849-997f-bd0c572466ef	2025-01-16	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Pearson Topical Anesthetic	BENZOCAINE	Pearson Dental Supplies INC.	e8aa9709-e8f6-47a6-ab29-1fef2309786b	2025-01-16	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Pearson Topical Anesthetic	BENZOCAINE	Pearson Dental Supplies INC.	8c55b39c-8231-46a1-92ef-9fb4e3f40c1e	2025-01-16	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Pearson Topical Anesthetic	BENZOCAINE	Pearson Dental Supplies INC.	9e82dc54-aeca-457f-b4b9-2f18cc269538	2025-01-16	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Pearson Topical Anesthetic	BENZOCAINE	Pearson Dental Supplies INC.	1a8f5964-770a-4d14-a7b6-18b5da9159b0	2025-01-16	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Quala Topical Anesthetic Gel	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.	d722cdf3-7671-eb27-e053-2a95a90a09c4	2025-01-16	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Quala Topical Anesthetic Gel	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.	d722bf24-ae85-54f6-e053-2995a90a1d35	2025-01-16	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Quala Topical Anesthetic Gel	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.	d721864d-0950-8379-e053-2a95a90a3bcb	2025-01-16	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Defend	BENZOCAINE	Mydent International	b0e5dc67-da7a-42ac-8657-e8e4da6914be	2025-01-16	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Quala Topical Anesthetic Gel	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.	d721ff57-0111-4bbb-e053-2995a90a1a70	2025-01-16	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Defend	BENZOCAINE	Mydent International	8129e871-5f31-4138-ae47-f8978fa6287f	2025-01-16	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Defend	BENZOCAINE	Mydent International	0301c1bc-db48-4635-97f5-9eaef7ab9579	2025-01-16	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Defend	BENZOCAINE	Mydent International	c0c88180-ccdc-4c48-b262-3ec20d4775d4	2025-01-16	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Defend	BENZOCAINE	Mydent International	ba011795-6822-4fff-b9c8-5c91cf9972a7	2025-01-16	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Defend	BENZOCAINE	Mydent International	1c6d5e87-3fad-4a2c-9e5f-96166d0beaeb	2025-01-16	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
Defend	BENZOCAINE	Mydent International	462a5f09-131f-4dfa-a502-547c44e4a4a5	2025-01-16	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5

Reported adverse events (FAERS/openFDA)#

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