Gelato Homecare

Product NDC: 68400-201
11-digit product format: 684000201
Labeler code: 68400
Product ID: 68400-201_1679a47c-dc75-72ca-e063-6294a90a39c0
Type: HUMAN OTC DRUG
Nonproprietary name: Stannous Fluoride
Dosage form: GEL
Route: DENTAL
Labeler: Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-01-05
Substance: STANNOUS FLUORIDE
Active strength: .116 g/120g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Gelato Homecare
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
STANNOUS FLUORIDE	.116 g/120g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3FTR44B32Q	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
237847	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1e93d4f8-1eec-40f8-8a6d-86e96dfeb8db	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68400-201-04	Gelato Homecare	120 g in 1 TUBE	GEL	120		7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Stannous Fluoride	ACTIVE INGREDIENT	3FTR44B32Q	GELATO HOMECARE (STANNOUS FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]	2
Fluoride Ion	ACTIVE MOIETY	Q80VPU408O	GELATO HOMECARE (STANNOUS FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]	2
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	4Q93RCW27E	GELATO HOMECARE (STANNOUS FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]	2
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	GELATO HOMECARE (STANNOUS FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	GELATO HOMECARE (STANNOUS FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]	2
Malic Acid	INACTIVE INGREDIENT	817L1N4CKP	GELATO HOMECARE (STANNOUS FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]	2
Water	INACTIVE INGREDIENT	059QF0KO0R	GELATO HOMECARE (STANNOUS FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]	2
Xanthan Gum	INACTIVE INGREDIENT	TTV12P4NEE	GELATO HOMECARE (STANNOUS FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68400-201	GELATO HOMECARE (STANNOUS FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]	7	Current NDC, Legacy NDC, 1 package rows	20240426_1e93d4f8-1eec-40f8-8a6d-86e96dfeb8db.zip

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 10 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Frida Fluoride Sweet Mint	SODIUM FLUORIDE	Fridababy, LLC	4f8b5a39-5d79-72cd-e063-6394a90a475c	2026-05-06	Warnings	Exact identifier application number: M021
Frida Fluoride Bubble Mint	SODIUM FLUORIDE	Fridababy, LLC	4f8b9af3-e4b3-b5e0-e063-6394a90a1068	2026-05-06	Warnings	Exact identifier application number: M021
Frida Fluoride Strawberry Toothbrush Set	SODIUM FLUORIDE	Fridababy, LLC	4f8ba14f-60ea-c2a8-e063-6394a90a7702	2026-05-06	Warnings	Exact identifier application number: M021
Frida Fluoride Strawberry	SODIUM FLUORIDE	Fridababy, LLC	4f814a62-8f91-8ea6-e063-6294a90a69eb	2026-05-06	Warnings	Exact identifier application number: M021
Gum Health Detoxify	STANNOUS FLUORIDE	Meijer, Inc	41d70733-a223-40fb-e063-6294a90a1397	2026-05-06	Warnings	Exact identifier application number: M021
Colgate Kids Unicorn Alcohol Free	SODIUM FLUORIDE	Colgate-Palmolive Company	133acaff-7205-80d7-e91d-3eb37087cae4	2026-05-05	Warnings	Exact identifier application number: M021
Crest 3D White Stain Eraser	SODIUM FLUORIDE	Procter & Gamble Manufactura, S. de R.L. de C.V.	fdefffbd-9c05-fa30-e053-6394a90a34bc	2026-05-05	Warnings	Exact identifier application number: M021
Frida Fluoride Watermelon	SODIUM FLUORIDE	Fridababy, LLC	4f8b49dc-e9e4-c341-e063-6294a90adb5a	2026-05-05	Warnings	Exact identifier application number: M021
White Glo Extreme White Whitening	SODIUM MONOFLUOROPHOSPHATE	White Glo USA Inc	4a2e0a8d-420e-4c07-aa43-386d05dab472	2026-04-30	Warnings	Exact identifier application number: M021
Equate Pro-Advanced TP Equate Pro-Advanced TP	STANNOUS FLUORIDE	Walmart Inc.	1e6561fb-4e3b-40ba-e063-6294a90a2690	2026-04-29	Warnings	Exact identifier application number: M021
Crest Cavity Protection Regular	SODIUM FLUORIDE	Procter & Gamble Manufactura, S. de R.L. de C.V.	852889b4-59ba-4592-b4fc-c0127a1ad075	2026-04-28	Warnings	Exact identifier application number: M021
Crest Complete Multi-Benefit Whitening plus Scope	SODIUM FLUORIDE	Procter & Gamble Manufactura, S. de R.L. de C.V.	0206710a-707f-4aa9-96b9-86240c1275dc	2026-04-28	Warnings	Exact identifier application number: M021
Alcohol Free Refreshing Mint	SODIUM FLUORIDE	H E B	cedf7c08-7412-4733-9b67-225b331cec8c	2026-04-27	Warnings, Adverse reactions	Exact identifier application number: M021
anzoon ANTIBACTERIAL MOUTH WASH	CETYLPYRIDINIUM CHLORIDE	Shandong AZC Biotechnology Co.,Ltd.	507c6896-2806-790c-e063-6394a90ac5ce	2026-04-27	Warnings	Exact identifier application number: M021
DELTA COMFORT PLUS AMENITY	SODIUM MONOFLUOROPHOSPHATE	Buzz Products Inc.	26434794-ae02-0f58-e063-6294a90ad85e	2026-04-24	Warnings	Exact identifier application number: M021
A and H Plus Therabreath Breath Freshners	SODIUM FLUORIDE	Church & Dwight Co., Inc.	18d6073e-b1ee-47d2-9758-2cf04f3cf3ca	2026-04-23	Warnings	Exact identifier application number: M021
Fluoride	SODIUM FLUORIDE	McKesson	5025e58e-e59c-07b6-e063-6394a90ac1e8	2026-04-23	Warnings	Exact identifier application number: M021
PRO-SYS	SENSITIVITY - MINT (OTC)	Benco Dental	4e46847e-8c1d-c988-e063-6394a90a8e50	2026-04-22	Warnings	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	H E B	87327a36-a314-4daa-83b6-b4bd3e26bba2	2026-04-22	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	H E B	8df324a7-9204-40f3-8ddb-1656286d7d4e	2026-04-22	Warnings, Adverse reactions	Exact identifier application number: M021

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3FTR44B32Q	STANNOUS FLUORIDE	7783-47-3	STANNOUS FLUORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
237847	stannous fluoride 0.4 % Oral Gel	PSN	1e93d4f8-1eec-40f8-8a6d-86e96dfeb8db	7
237847	stannous fluoride 0.004 MG/MG Oral Gel	SCD	1e93d4f8-1eec-40f8-8a6d-86e96dfeb8db	7
237847	stannous fluoride 0.4 % (fluoride ion 0.16 % ) Oral Gel	SY	1e93d4f8-1eec-40f8-8a6d-86e96dfeb8db	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68400-201-04	68400020104	120 g in 1 TUBE (68400-201-04)	120 g	2016-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gelato Homecare	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.	2024-04-19	HUMAN OTC DRUG LABEL	7