NDC 68400-503 - 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: 68400-503
Package NDCs from labels: 68400-503-25
Manufacturer: Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.
Effective date: 2013-12-26
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.	2013-12-26	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68400-503-25	2020-01-31	C162847	48780-1	9d75b9d0-a25b-f424-e053-dadaa90a57ce	1be6cd7a-3f9c-4661-85e4-4a310b490ad3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68400-503-25	Gelato Topical Anesthetic	12 g in 1 JAR	GEL	12		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68400-503	GELATO TOPICAL ANESTHETIC (BENZOCAINE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]	3	1 package rows	20140102_1be6cd7a-3f9c-4661-85e4-4a310b490ad3.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.]	3
Benzocaine	ACTIVE MOIETY	U3RSY48JW5	GELATO TOPICAL ANESTHETIC (BENZOCAINE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]	3
Polyethylene Glycol 3350	INACTIVE INGREDIENT	G2M7P15E5P	GELATO TOPICAL ANESTHETIC (BENZOCAINE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]	3
Polyethylene Glycol 400	INACTIVE INGREDIENT	B697894SGQ	GELATO TOPICAL ANESTHETIC (BENZOCAINE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]	3
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	GELATO TOPICAL ANESTHETIC (BENZOCAINE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]	3

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 31 of 40 · 794 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anti-Itch Medicated Maximum Strength	BENZOCAINE AND RESORCINOL	Walgreens Company	7fd86dcb-edef-4d0d-b389-7ecea595fe67	2024-11-20	Warnings	Exact identifier unii: U3RSY48JW5
Walgreens Pain Relief	BENZOCAINE	Walgreens Company	7cee7234-32cd-4bf3-8a6c-0882585eec7f	2024-11-20	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
First Aid Only Sting Relief Pad	BENZOCAINE	Acme United Corporation	5087cbbd-1bbe-62ed-e054-00144ff8d46c	2024-11-19	Warnings	Exact identifier unii: U3RSY48JW5
Sting Relief Pad	BENZOCAINE, ISOPROPYL ALCOHOL	Acme United Corporation	6bb9a782-2394-4c8c-e053-2991aa0a08d4	2024-11-19	Warnings	Exact identifier unii: U3RSY48JW5
First Aid Only Sting Relief	BENZOCAINE	Acme United Corporation	697127d1-c02e-16d2-e053-2a91aa0a39fd	2024-11-19	Warnings	Exact identifier unii: U3RSY48JW5
TANAC Oral Pain Reliever	BENZOCAINE	Leosons Overseas Corp	81cc61fa-31a7-2214-e053-2a91aa0ae46a	2024-11-15	Warnings	Exact identifier unii: U3RSY48JW5
Visine Red Eye Hydrating Comfort Eye Drops	TETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400	Kenvue Brands LLC	a9a90de6-3172-4d34-984b-f4442f880e3d	2024-11-13	Warnings	Exact identifier unii: B697894SGQ
Visine Dry Eye Relief	POLYETHYLENE GLYCOL 400	Kenvue Brands LLC	2de7a41d-661d-495f-89b4-5690664a3a3d	2024-11-13	Warnings	Exact identifier unii: B697894SGQ
Visine Dry Eye Relief Eye Drops	POLYETHYLENE GLYCOL 400	Kenvue Brands LLC	d9d3f000-3ce4-4ba2-a7fb-491b44eb3fa1	2024-11-13	Warnings	Exact identifier unii: B697894SGQ
Visine Dry Eye Relief	POLYETHYLENE GLYCOL 400	Kenvue Brands LLC	a4c57620-778f-4434-9105-ead2f85c5884	2024-11-13	Warnings	Exact identifier unii: B697894SGQ
Orajel 2X Medicated Gel	ORAL PAIN RELIEVER	Church & Dwight Co., Inc.	262be295-4eaf-3136-e063-6294a90a7dcc	2024-11-05	Warnings	Exact identifier unii: U3RSY48JW5
DEBACHERE Butt Balm After Care Antiseptic Pain Relief	BENZOCAINE, BENZALKONIUM CHLORIDE	DE.BACHERE USA LLC	8ba42864-69bf-455c-98d4-7f4ff94edceb	2024-10-29	Warnings	Exact identifier unii: U3RSY48JW5
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043bfbc3-c33b-78b7-e063-6294a90a1a5a	2024-10-29	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043bfbc3-c33a-78b7-e063-6294a90a1a5a	2024-10-29	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043a3cb4-f560-0ffd-e063-6394a90a2ff6	2024-10-29	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	1f3d68f6-afd6-42e7-b3e5-210228c8e7de	2024-10-28	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals LLC	0dd15227-6603-42ac-9a5f-f2dc49e0382a	2024-10-28	Warnings, Adverse reactions	Exact identifier rxcui: 238910 unii: U3RSY48JW5
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	0605d5d6-82bd-415e-b5cb-e273f934a4a7	2024-10-28	Warnings	Exact identifier rxcui: 238910 unii: U3RSY48JW5
HurriCaine Topical Anesthetic Liquid	BENZOCAINE	Beutlich Pharmaceuticals, LLC	f70fa3fc-cd65-4a80-9efd-129e98fd3998	2024-10-28	Warnings	Exact identifier unii: U3RSY48JW5
Chloraspetic	MENTHOL AND BENZOCAINE	Prestige Brands Holdings, Inc.	2b1808b2-2574-4ab8-a762-5733251848ce	2024-10-25	Warnings	Exact identifier unii: U3RSY48JW5

Reported adverse events (FAERS/openFDA)#

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