Home Care Fluoride

Product NDC: 55346-0404
11-digit product format: 553460404
Labeler code: 55346
Product ID: 55346-0404_42c873be-f572-d9df-e063-6394a90a16b4
Type: HUMAN OTC DRUG
Nonproprietary name: Stannous Fluoride
Dosage form: GEL
Route: DENTAL; ORAL
Labeler: Dental Technologies, Inc.
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1999-12-31
Substance: STANNOUS FLUORIDE
Active strength: .969 mg/g
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: Home Care Fluoride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
STANNOUS FLUORIDE	.969 mg/g

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 SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
16ebcb37-5703-4e10-b965-570e18434b52	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55346-0404-1	Home Care Fluoride	121.9 g in 1 TUBE	GEL	121.9		12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
STANNOUS FLUORIDE	ACTIVE INGREDIENT	3FTR44B32Q	HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]	7
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]	7
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]	7
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]	7
CARBOMER 934	INACTIVE INGREDIENT	Z135WT9208	HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]	7
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]	7
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55346-0404	HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]	11	Current NDC, Legacy NDC, 1 package rows	20240207_16ebcb37-5703-4e10-b965-570e18434b52.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 36 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cloveden Sensitive Care Tooth	SODIUM FLUORIDE	DONG IL PHARMS CO.,LTD	3fb153f1-ba6e-7251-e063-6294a90abe62	2025-09-26	Warnings	Exact identifier application number: M021
Cloveden 100 times higher concentrated	CETYLPYRIDINIUM CHLORIDE	DONG IL PHARMS CO.,LTD	3fb1a2ee-381e-a9e8-e063-6394a90a864b	2025-09-26	Warnings	Exact identifier application number: M021
unpa Cha Cha Toothpaste	SODIUM MONOFLUOROPHOSPHATE	Lycl Inc.	230b3cf2-053a-4e8b-8d50-05bbc877faa8	2025-09-25	Warnings	Exact identifier application number: M021
TheraBreath Anticavity	SODIUM FLUORIDE	Church & Dwight Co., Inc.	3c5d58f1-ea8c-4708-bbc6-21e1cd1446da	2025-09-19	Warnings	Exact identifier application number: M021
Optimax Professional Whitening Anticavity Fluoride	SODIUM MONOFLUOROPHOSPHATE	WHITE GLO USA INC	8c4b9db9-8f23-4dd5-ab6e-1c2f9a3da5b1	2025-09-18	Warnings	Exact identifier application number: M021
Optimax Professional Whitening Anticavity Fluoride	SODIUM MONOFLUOROPHOSPHATE	WHITE GLO USA INC	c1bbdd36-53fb-43a3-ba20-afbeb6359d31	2025-09-18	Warnings	Exact identifier application number: M021
Brush Buddies Cookies n Cream Ice Cream FLAVORED Anticavity Fluoride	SODIUM FLUORIDE	Ashtel Studios, Inc.	f70d378b-d4d6-454c-90a9-794459960c8c	2025-09-17	Warnings	Exact identifier application number: M021
Brush Buddies Chocolate Ice Cream FLAVORED Anticavity Fluoride	SODIUM FLUORIDE	Ashtel Studios, Inc.	26b9b2dd-7cb2-47c3-8bbb-94a48f02dd21	2025-09-16	Warnings	Exact identifier application number: M021
Brush Buddies Mint Chocolate Chip Ice Cream FLAVORED Anticavity Fluoride	SODIUM FLUORIDE	Ashtel Studios, Inc.	3436532d-e078-4dbb-a823-b4542e961534	2025-09-16	Warnings	Exact identifier application number: M021
Colgate Total Plaque Pro Release Fresh Mint	STANNOUS FLUORIDE	Colgate-Palmolive Company	9b1671c4-8680-6e2a-9f10-0400840ca5a9	2025-09-12	Warnings	Exact identifier application number: M021
Colgate Total Plaque Pro Release Whitening	STANNOUS FLUORIDE	Colgate-Palmolive Company	ddc09ce5-181a-1b50-7094-314bb58a15cf	2025-09-12	Warnings	Exact identifier application number: M021
Cavity Protection Fresh Mint Anticavity Mouthwash	SODIUM FLUORIDE	Oxyfresh Worldwide Inc	3efc66b2-fcf9-4d26-9cdd-1af8225312b4	2025-09-10	Warnings	Exact identifier application number: M021
CLOSE UP Freshening with Mouthwash	SODIUM FLUORIDE	Church & Dwight Co., Inc.	e660b0d7-4cc5-4028-bdf5-016b85899728	2025-09-09	Warnings	Exact identifier application number: M021
Essentials Healthy Teeth and Gums	SODIUM FLUORIDE 0.24%	Church & Dwight Co., Inc.	9652c004-6b47-840f-e053-2995a90a6e98	2025-09-09	Warnings	Exact identifier application number: M021
Complete Care Whole Mouth Protection	SODIUM FLUORIDE	Church & Dwight Co., Inc.	d00f9d16-de0e-4ffc-e053-2a95a90a2069	2025-09-09	Warnings	Exact identifier application number: M021
Brush Buddies Vanilla Ice Cream FLAVORED Anticavity Fluoride	SODIUM FLUORIDE	Ashtel Studios, Inc.	e911effb-d59f-4054-9501-803b64369ab4	2025-09-05	Warnings	Exact identifier application number: M021
The Simpsons Purple Squishee Flavor Sodium Fluoride Anticavity Toothpast	SODIUM FLUORIDE	HISMILE PTY LTD	3de10638-1a39-b747-e063-6294a90a4ca5	2025-09-03	Warnings	Exact identifier application number: M021
Optimax Purple Anticavity Fluoride	SODIUM MONOFLUOROPHOSPHATE	WHITE GLO USA INC	8264e849-a6b3-4953-a85b-da9d4e7f5a70	2025-09-02	Warnings	Exact identifier application number: M021
CAREKON ANTI-CAVITY FLUORIDE	SODIUM MONOFLUOROPHOSPHATE	Hunan Yinhuatang Pharmaceutical Technology Co., Ltd.	3baca3b6-ff48-0579-e063-6394a90abd08	2025-08-29	Warnings	Exact identifier application number: M021
Brush Buddies 2 VALUE PACK CAVITY PROTECTION ANTI-CAVITY FLUORIDE	SODIUM MONOFLUOROPHOSPHATE	Ashtel Studios, Inc.	fc794fe5-7135-4b2b-b002-a75908223f20	2025-08-13	Warnings	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55346-0404-1	55346040401	121.9 g in 1 TUBE (55346-0404-1)	121.9 g	1999-12-31	0000-00-00	No	No	Current