Fluoridex

Product NDC: 59883-004
11-digit product format: 598830004
Labeler code: 59883
Product ID: 59883-004_0a96438c-733f-8bce-e063-6394a90a0ce7
Type: HUMAN OTC DRUG
Nonproprietary name: Stannous Fluoride Rinse
Dosage form: LIQUID
Route: ORAL
Labeler: DEN-MAT HOLDINGS, LLC
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-01-11
Substance: STANNOUS FLUORIDE
Active strength: 1.53 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: Fluoridex
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
STANNOUS FLUORIDE	1.53 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
5e81f073-c0ca-aa38-e053-2a91aa0ab37b	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59883-004-01	Fluoridex	310 g in 1 BOTTLE, PLASTIC	LIQUID	310		3
59883-004-01	Fluoridex	1 in 1 BOX	LIQUID	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59883-004	FLUORIDEX (STANNOUS FLUORIDE RINSE) LIQUID [DEN-MAT HOLDINGS, LLC]	3	Current NDC, Legacy NDC, 2 package rows	20231216_5e81f073-c0ca-aa38-e053-2a91aa0ab37b.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 50 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
United Airlines Therabody Polaris Kit	SODIUM MONOFLUOROPHOSPHATE	Wessco International	ab667740-55ab-470e-9514-163961502ceb	2023-10-26	Warnings	Exact identifier application number: M021
Cavity Protection Fresh Mint	SODIUM FLUORIDE	Oxyfresh Worldwide Inc	0ae98f28-7e78-4379-93b0-4f2657415c4d	2023-10-25	Warnings	Exact identifier application number: M021
Tanners Tasty Vanilla Bling	SODIUM FLUORIDE	Sheffield Pharmaceuticals LLC	521fe01e-7f2e-4d79-9126-e4880cdf4e71	2023-10-24	Warnings	Exact identifier application number: M021
Tanners Tasty Ooh La La Orange	SODIUM FLUORIDE	Sheffield Pharmaceuticals LLC	6027b961-314e-4f71-8b2f-646ce80214d8	2023-10-24	Warnings	Exact identifier application number: M021
Tanners Tasty Cha Cha Chocolate	SODIUM FLUORIDE	Sheffield Pharmaceuticals LLC	8609dbf3-7620-4a13-b40b-6bd705a78fb0	2023-10-24	Warnings	Exact identifier application number: M021
Glister Multi-Action	SODIUM FLUORIDE	Access Business Group LLC	e3f2c049-a0f5-4649-a4aa-11bdb252f951	2023-10-23	Warnings	Exact identifier application number: M021
UNITED Asutra TC Kit Colgate	SODIUM MONOFLUOROPHOSPHATE	MING FAI ENTERPRISE (CAMBODIA) CO., LTD	082a581a-c7e5-e614-e063-6394a90a87da	2023-10-20	Warnings	Exact identifier application number: M021
Plak Smacker Anti Cavity Fluoride	SODIUM FLUORIDE	YOUNG PS ACQUISITION, LLC	c6dee5fa-9cd4-4a94-9cbe-e977b2bd3dfe	2023-10-16	Warnings	Exact identifier application number: M021
Ionite H	STANNOUS FLUORIDE	Dharma Research, Inc.	152d84ee-d981-4032-bfb1-a559afe71d40	2023-10-11	Warnings	Exact identifier application number: M021
Sodium Fluoride	SODIUM FLUORIDE	Safco Dental Supply LLC	788080b3-fff8-4049-af98-f571824994c2	2023-10-11	Warnings	Exact identifier application number: M021
Ionite H	STANNOUS FLUORIDE	Dharma Research, Inc.	5c312b36-07f4-406e-b3d3-c6d1e964635d	2023-10-11	Warnings	Exact identifier application number: M021
Ionite H	STANNOUS FLUORIDE	Dharma Research, Inc.	042636cf-8b61-4022-b0a1-af09c06b145b	2023-10-11	Warnings	Exact identifier application number: M021
Ionite H	STANNOUS FLUORIDE	Dharma Research, Inc.	f4c3569b-7b6a-4566-9e87-492f291c5165	2023-10-11	Warnings	Exact identifier application number: M021
UNITED Asutra TC Kit Colgate	SODIUM MONOFLUOROPHOSPHATE	Procurall Solutions	042817f9-675f-056a-e063-6394a90a2d97	2023-08-30	Warnings	Exact identifier application number: M021
Colgate Max Fresh Cool Mint	SODIUM FLUORIDE	Mission Hills S.A de C.V	d142e43f-415a-41c5-a7db-8b18a039a323	2019-04-09	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	Marketing start	Marketing end	Sample	Exclude flag	Status
59883-004-01	59883000401	1 BOTTLE, PLASTIC in 1 BOX (59883-004-01) / 310 g in 1 BOTTLE, PLASTIC	2016-01-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluoridex - 0.63% Stannous Fluoride Rinse	DEN-MAT HOLDINGS, LLC	2023-11-20	HUMAN OTC DRUG LABEL	3