Home Care Fluoride

Product NDC: 55346-0401
11-digit product format: 553460401
Labeler code: 55346
Product ID: 55346-0401_42c8aa46-9e15-ec47-e063-6294a90a06c3
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	55346-0401		D	Discontinued by firm		2026-10-15
excluded package	package	55346-0401	55346-0401-2	D	Discontinued by firm		2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55346-0401-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55346-0401-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55346-0401-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55346-0401-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55346-0401-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55346-0401-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55346-0401-2	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55346-0401-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55346-0401-2	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55346-0401-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55346-0401-2	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55346-0401-2	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
15bdc03e-2cc7-4b7d-96fc-4f3236ed5c75	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
55346-0401-1	Home Care Fluoride	121.9 g in 1 TUBE	GEL	121.9		10

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.]	4
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]	4
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]	4
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]	4
CARBOMER 934P	INACTIVE INGREDIENT	Z135WT9208	HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]	4
Trolamine	INACTIVE INGREDIENT	9O3K93S3TK	HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55346-0401	HOME CARE FLUORIDE (STANNOUS FLUORIDE) GEL [DENTAL TECHNOLOGIES, INC.]	9	Current NDC, Legacy NDC, 1 package rows	20240207_15bdc03e-2cc7-4b7d-96fc-4f3236ed5c75.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 28 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Crest Pro-Health Gum Detoxify Plus	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	2f9e346e-d664-81d5-e063-6394a90a4525	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Holiday Smile Deep Stain Remover and Whitestrips	SODIUM MONOFLUOROPHOSPHATE	The Procter & Gamble Manufacturing Company	3c57d487-a3c7-b238-e063-6294a90aed81	2026-01-08		Exact identifier application number: M021
Crest Complete plus Scope Pro Advanced Freshness	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	325c3ab2-aaa2-a06f-e063-6294a90abefb	2026-01-08	Warnings	Exact identifier application number: M021
Crest Tartar Protection	SODIUM FLUORIDE	Procter & Gamble Manufactura, S. de R.L. de C.V.	5940711d-71b7-cb7d-e053-2a91aa0aef18	2026-01-08	Warnings	Exact identifier application number: M021
Meijer Restore and Defend Sensitive	STANNOUS FLUORIDE	Meijer Distribution Inc	82bdfdb5-39f2-8c09-e053-2991aa0a096c	2026-01-08	Warnings	Exact identifier application number: M021
Crest Strawberry	SODIUM FLUORIDE	Procter & Gamble Manufactura, S. de R.L. de C.V.	01f69824-e886-6e7b-e063-6294a90acf77	2026-01-08	Warnings	Exact identifier application number: M021
Crest Bubblegum	SODIUM FLUORIDE	Procter & Gamble Manufacturing Mxico, S. de R.L. de C.V.	01f64874-6363-3dcc-e063-6394a90a2aec	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Fresh Mint	SODIUM FLUORIDE	Procter & Gamble Manufactura, S. de R.L. de C.V.	01f27a63-15f3-cee4-e063-6394a90afa3b	2026-01-08	Warnings	Exact identifier application number: M021
Crest Bubblegum	SODIUM FLUORIDE	Procter & Gamble Manufacturing Mxico, S. de R.L. de C.V.	01f618d7-be07-18c3-e063-6294a90a2d97	2026-01-08	Warnings	Exact identifier application number: M021
Crest Strawberry	SODIUM FLUORIDE	Procter & Gamble Manufactura, S. de R.L. de C.V.	01f35279-76ce-6027-e063-6294a90a8e34	2026-01-08	Warnings	Exact identifier application number: M021
Crest Snowberry	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	42ca1f06-3e7d-8fed-e063-6394a90afbff	2026-01-08	Warnings	Exact identifier application number: M021
Crest Strawberry	SODIUM FLUORIDE	Procter & Gamble Manufactura, S. de R.L. de C.V.	7d615c52-f9c9-4856-e053-2991aa0a7927	2026-01-08	Warnings	Exact identifier application number: M021
Crest Fresh and White	SODIUM FLUORIDE	Procter & Gamble Manufactura, S. de R.L. de C.V.	5a1bb1fb-12a5-5fd1-e053-2991aa0a628b	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Stain Eraser Icy Clean Mint	SODIUM FLUORIDE	Procter & Gamble Manufacturing Mxico, S. de R.L. de C.V.	8de12c9f-eb16-aa26-e053-2a95a90a1b9c	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro Health Peppermint Frost	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	42c84772-d406-b6ca-e063-6394a90a920f	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Sparkle Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	42cb1b2a-55ad-cb9c-e063-6294a90ac88c	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Gum Recession	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	47be4eff-1ab5-17a1-e063-6394a90ae465	2026-01-08	Warnings	Exact identifier application number: M021
Supersmile Professional Whitening TP	SODIUM MONOFLUOROPHOSPHATE	Robell Research, Inc	25021787-44e8-0b29-e063-6394a90a0af6	2026-01-08	Warnings	Exact identifier application number: M021
Supersmile Professional whitening TP Original Mint	SODIUM MONOFLUOROPHOSPHATE	Robell Research, Inc	2502c305-71ab-bb71-e063-6394a90a0a84	2026-01-08	Warnings	Exact identifier application number: M021
Supersmile Professional Whitening TP Original Mint	SODIUM MONOFLUOROPHOSPHATE	Robell Research, Inc	2502840c-82ee-12cb-e063-6394a90a5b3f	2026-01-08	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
55346-0401-1	55346040101	121.9 g in 1 TUBE (55346-0401-1)	121.9 g	1999-12-31	0000-00-00	No	No	Current