Home Care Fluoride

Product NDC: 55346-0408
11-digit product format: 553460408
Labeler code: 55346
Product ID: 55346-0408_42c872dd-4a65-b88b-e063-6394a90aab20
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
c44686f8-93ee-4a8f-8481-3439d123f6d2	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55346-0408-1	Home Care Fluoride	121.9 g in 1 TUBE	GEL	121.9		11

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.]	5
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]	5
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]	5
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]	5
CARBOMER 934P	INACTIVE INGREDIENT	Z135WT9208	HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]	5
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]	5
Trolamine	INACTIVE INGREDIENT	9O3K93S3TK	HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55346-0408	HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]	10	Current NDC, Legacy NDC, 1 package rows	20240207_c44686f8-93ee-4a8f-8481-3439d123f6d2.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 3 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SprinJene White Boost	SODIUM FLUORIDE	Health and Natural Beauty USA Corp	8c401bea-0148-46a0-bbb3-80c17f9e8e3e	2026-08-14	Warnings	Exact identifier application number: M021
ULTRA BRITE Baking Soda and Peroxide Whitening Cool Mint	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	2b123d70-4f7d-41b0-b48f-711999e97ee0	2026-08-13	Warnings	Exact identifier application number: M021
COLGATE STRAWBERRY BURST	SODIUM FLUORIDE	Colgate-Palmolive Company	d037f65c-3d22-4d2a-a0a9-3dcba2357ebd	2026-08-13	Warnings	Exact identifier application number: M021
COLGATE OPTIC WHITE PRO SERIES ENAMEL RENEWAL SOOTHING MINT	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	cd954777-697a-4cc7-8f5f-b2caf357ef95	2026-08-13	Warnings	Exact identifier application number: M021
TOMS OF MAINE KIDS SILLY STRAWBERRY	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	e36ceb7a-9a29-41d8-8d08-a859e515f1f5	2026-08-13	Warnings	Exact identifier application number: M021
TOMS OF MAINE WHOLE CARE SPEARMINT	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	08d7ed04-67a4-437a-82c5-496f9893c6c7	2026-08-10	Warnings	Exact identifier application number: M021
TOMS OF MAINE WICKED FRESH COOL PEPPERMINT	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	27278b02-c4fd-4092-a632-a14e442f5a95	2026-08-10	Warnings	Exact identifier application number: M021
TOMS OF MAINE WICKED FRESH SPEARMINT ICE	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	59a6b9ac-c28b-4ec3-8231-f35054ce0eaf	2026-08-10	Warnings	Exact identifier application number: M021
Toms Kids Watermelon Wiggle	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	48eaafb6-99f4-5fd1-10fc-4ea35cbb2c62	2026-08-10	Warnings	Exact identifier application number: M021
AutoBrush kids bubblegum	SODIUM FLUORIDE	Lander Enterprises, LLC	64b60e74-fceb-4de9-a966-73bf8dbd666c	2026-08-10	Warnings	Exact identifier application number: M021
AutoBrush kids strawberry	SODIUM FLUORIDE	Lander Enterprises, LLC	7e880d50-8aab-4d57-abc1-e900070f9a11	2026-08-10	Warnings	Exact identifier application number: M021
AutoBrush kids watermelon	SODIUM FLUORIDE	Lander Enterprises, LLC	5cb5eb46-705c-4bb7-bef1-e93a598636fd	2026-08-10	Warnings	Exact identifier application number: M021
AutoBrush Mint	SODIUM FLUORIDE	Lander Enterprises, LLC	0e043431-9d87-478d-87f5-5aa8b0a932eb	2026-08-10	Warnings	Exact identifier application number: M021
Willo Minty Mist Dye Free	SODIUM FLUORIDE	Willo 32, Inc.	3ee5b49e-ca9a-ece6-e063-6394a90a3d00	2026-08-10	Warnings	Exact identifier application number: M021
Willo Bubble Twist	SODIUM FLUORIDE	Willo 32 Inc	36560d62-e901-1f93-e063-6394a90a2803	2026-08-10	Warnings	Exact identifier application number: M021
Willo Berry Splash Dye Free	SODIUM FLUORIDE	Willo 32, Inc	3ea91af9-2895-e530-e063-6394a90a39e5	2026-08-10	Warnings	Exact identifier application number: M021
Fluoride Mouth Rinse Anticavity	SODIUM FLUORIDE	Target Corporation	3daf3cc3-585a-4bb2-9b56-7117d220ed38	2026-08-10	Warnings, Adverse reactions	Exact identifier application number: M021
TOMS OF MAINE KIDS OUTRAGEOUS ORANGE MANGO	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	19de1e71-ab94-415f-b66d-e5748dea8317	2026-08-10	Warnings	Exact identifier application number: M021
TOMS OF MAINE WHOLE CARE WINTERMINT	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	d5e1396e-0253-4ec0-a9ff-b61bda70de35	2026-08-10	Warnings	Exact identifier application number: M021
TOMS OF MAINE WICKED COOL MILD MINT	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	de92408c-d401-47c3-94ee-fb6c08092651	2026-08-10	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
55346-0408-1	55346040801	121.9 g in 1 TUBE (55346-0408-1)	121.9 g	1999-12-31	0000-00-00	No	No	Current