Pro-Den Rx

Product NDC: 59883-720
11-digit product format: 598830720
Labeler code: 59883
Product ID: 59883-720_0a95fcbe-e811-031d-e063-6294a90aec1b
Type: HUMAN OTC DRUG
Nonproprietary name: Stannous Fluoride
Dosage form: RINSE
Route: ORAL
Labeler: Den-mat Holdings, Llc
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2008-10-31
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: Pro-Den Rx
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
9036aa8a-59b1-41b0-b3cb-529d3303a1c0	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59883-720-08	Pro-Den Rx	283.5 g in 1 BOTTLE	RINSE	283.5		6
59883-720-08	Pro-Den Rx	1 in 1 CARTON	RINSE	1		6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
STANNOUS FLUORIDE	ACTIVE INGREDIENT	3FTR44B32Q	PRO-DEN RX (SODIUM FLUORIDE) GEL [ZILA THERAPEUTICS, INC.]	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	PRO-DEN RX (SODIUM FLUORIDE) GEL [ZILA THERAPEUTICS, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PRO-DEN RX (SODIUM FLUORIDE) GEL [ZILA THERAPEUTICS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59883-720	PRO-DEN RX (STANNOUS FLUORIDE) RINSE [DEN-MAT HOLDINGS, LLC]	6	Current NDC, Legacy NDC, 2 package rows	20231216_9036aa8a-59b1-41b0-b3cb-529d3303a1c0.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 8 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Crest Premium Plus Scope Active Foam plus Whitening Dualblast Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	5500f9ab-b0c4-51d6-e063-6394a90acd38	2026-06-24	Warnings	Exact identifier application number: M021
Crest Premium Plus Deep Clean Active Foam plus Whitening Foaming Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	5504ec96-aae1-f5f9-e063-6294a90ad8bb	2026-06-24	Warnings	Exact identifier application number: M021
COLGATE SPARKLING WHITE CINNAMINT	SODIUM FLUORIDE	Colgate-Palmolive Company	f2ff18d2-4ef0-454e-a6f1-6f3bf361c7d1	2026-06-24	Warnings	Exact identifier application number: M021
Crest Plus Scope plus Whitening Minty Fresh with Mouthwash	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	54ed8e02-3c2f-750c-e063-6394a90a4d33	2026-06-23	Warnings	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	H E B	c68b0644-685d-4c62-bf5d-3a5bbea3b052	2026-06-22	Warnings, Adverse reactions	Exact identifier application number: M021
Tom Whole Care Peppermint fights cavities whitening fresh breath helps fight tartar	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	fdbadaae-eab7-4d9a-acf7-815ca93f877c	2026-06-16	Warnings	Exact identifier application number: M021
Natural Fluoride Fresh Mint cavity protection whitening fresh breath	SODIUM FLUORIDE	Tom's of Maine, Inc.	fce5e8b5-34f8-4a45-a662-82c903419809	2026-06-16	Warnings	Exact identifier application number: M021
Toms Whole Care Spearmint fights cavities whitening fresh breath helps fight tartar	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	ebb62015-0027-459a-a9cf-56b640f9f456	2026-06-16	Warnings	Exact identifier application number: M021
Toms Wicked Fresh Spearmint Ice fresh breath / cavity protection	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	b9962eac-186e-4da2-929d-393f18ed0234	2026-06-16	Warnings	Exact identifier application number: M021
Toms Wicked Fresh Cool Peppermint fresh breath / cavity protection	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	1c029b10-29b0-4131-9134-cebfca4328a3	2026-06-16	Warnings	Exact identifier application number: M021
Toms Whole Care Cinnamon Clove FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	3e7ab39a-989c-4924-af3e-689404912bee	2026-06-16	Warnings	Exact identifier application number: M021
Crest Plus Cinnamon plus Whitening	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	53fb780d-3e8b-6747-e063-6294a90a8211	2026-06-11	Warnings	Exact identifier application number: M021
Colgate Total SF Whitening	STANNOUS FLUORIDE	COLGATE PALMOLIVE COMPANY	7f6b6aa8-50da-151b-c448-9e427d37398f	2026-06-11	Warnings	Exact identifier application number: M021
Colgate MaxClean with Whitening Smartfoam	SODIUM FLUORIDE	Colgate-Palmolive Company	c712ae6b-eff3-4c54-b1fc-37304758d059	2026-06-11	Warnings	Exact identifier application number: M021
Colgate Total Sensitivity Mineral Shield	STANNOUS FLUORIDE	Colgate-Palmolive Company	f065318c-1e2a-c04d-f254-f8127b05a88f	2026-06-10	Warnings	Exact identifier application number: M021
Toms Whole Care Mouthwash Fresh Mint	SODIUM FLUORIDE	Tom's of Maine, Inc.	6875f5c1-853c-43da-8226-c09a5518f9bb	2026-06-10	Warnings	Exact identifier application number: M021
Colgate Total SF Fresh Mint Stripe	STANNOUS FLUORIDE	COLGATE PALMOLIVE COMPANY	657020c7-e85c-4c61-9f62-b50351e4b4e5	2026-06-10	Warnings	Exact identifier application number: M021
Optimax Anticavity Fluoride Bubblegum	SODIUM MONOFLUOROPHOSPHATE	White Glo USA Inc	1adc752b-2ba8-4d8f-b4f1-5741f864255b	2026-06-09	Warnings	Exact identifier application number: M021
Kids Crest Cavity Protection Sparkle Fun	SODIUM FLUORIDE	Procter & Gamble Manufactura, S. de R.L. de C.V.	df182c22-bbf1-448d-81e8-35cb431d2afc	2026-06-08	Warnings	Exact identifier application number: M021
PEROXICARE	SODIUM FLUORIDE	Church & Dwight Co., Inc.	55262538-15ce-455c-93b1-bb02b5f81d6b	2026-06-07	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
59883-720-08	59883072008	1 BOTTLE in 1 CARTON (59883-720-08) / 283.5 g in 1 BOTTLE	1 bottle	2008-10-31	0000-00-00	No	No	Current