CloSYS Silver Sensitive Mouth Rinse

Product NDC: 58578-0517
11-digit product format: 585780517
Labeler code: 58578
Product ID: 58578-0517_5b621757-befa-4ce3-920d-b884aca94420
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium Fluoride
Dosage form: RINSE
Route: ORAL
Labeler: Rowpar Pharmaceuticals, Inc.
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-01-01
Substance: SODIUM FLUORIDE
Active strength: .02 g/100mL
NDC exclude flag: No
Listing certified through: 2027-12-31
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: CloSYS Silver Sensitive Mouth Rinse
Brand name suffix: Fluoride Rinse
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM FLUORIDE	.02 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8ZYQ1474W7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313029	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
98a8cee8-9f3c-4a4a-89f8-72e1f1b06796	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58578-0517-1	CloSYS Silver Sensitive Mouth RinseFluoride Rinse	473 mL in 1 BOTTLE	RINSE	473	5
58578-0517-1	CloSYS Silver Sensitive Mouth RinseFluoride Rinse	1 in 1 BOX	RINSE	1	5
58578-0517-2	CloSYS Silver Sensitive Mouth RinseFluoride Rinse	2 in 1 PACKAGE	RINSE	2	5
58578-0517-2	CloSYS Silver Sensitive Mouth RinseFluoride Rinse	946 mL in 1 BOTTLE	RINSE	946	5
58578-0517-3	CloSYS Silver Sensitive Mouth RinseFluoride Rinse	946 mL in 1 BOTTLE	RINSE	946	5
58578-0517-3	CloSYS Silver Sensitive Mouth RinseFluoride Rinse	3 in 1 PACKAGE	RINSE	3	5
58578-0517-4	CloSYS Silver Sensitive Mouth RinseFluoride Rinse	946 mL in 1 BOTTLE	RINSE	946	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58578-0517	CLOSYS SILVER SENSITIVE MOUTH RINSE FLUORIDE RINSE (SODIUM FLUORIDE) RINSE [ROWPAR PHARMACEUTICALS, INC.]	4	Current NDC, Legacy NDC, 7 package rows	20250523_98a8cee8-9f3c-4a4a-89f8-72e1f1b06796.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 4 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TOMS OF MAINE ACTIVATED CHARCOAL PEPPERMINT	SODIUM FLUORIDE	Tom's of Maine, Inc.	b9e6e455-8444-4805-89f1-ee9142f98e36	2026-08-10	Warnings	Exact identifier application number: M021
TOMS OF MAINE WHOLE CARE SPEARMINT	SODIUM MONOFLUOROPHOSPHATE	Tom's of Maine, Inc.	7db8e49d-1073-4a81-a3a4-f3a19ebce921	2026-08-10	Warnings	Exact identifier application number: M021
TOMS OF MAINE WHITEN PLUS DEEP CLEAN SPEARMINT	SODIUM FLUORIDE	Tom's of Maine, Inc.	1fe50b49-bc62-4137-866c-e87bb878a96d	2026-08-10	Warnings	Exact identifier application number: M021
Colgate Optic White Stain Fighter With Baking Soda	SODIUM FLUORIDE	Colgate-Palmolive Company	8e6113e2-101b-4bde-90e9-6ab32c6ebf5c	2026-08-05	Warnings	Exact identifier application number: M021
COLGATE MAX FRESH WATERMELON BLAST	SODIUM FLUORIDE	Colgate-Palmolive Company	6c391ef3-d625-403c-a4dc-6e2212682ed1	2026-08-04	Warnings	Exact identifier application number: M021
Rorobell WaWa Tooth	SODIUM MONOFLUOROPHOSPHATE	ROROBELL	93113481-ad9d-4be0-a7b7-a72c8726127d	2026-08-03	Warnings	Exact identifier application number: M021
COLGATE OPTIC WHITE CHARCOAL	SODIUM FLUORIDE	Colgate-Palmolive Company	70ed4a93-b68f-4198-b4b7-7cfeb17ba5d2	2026-07-30	Warnings	Exact identifier application number: M021
Colgate Optic White Charcoal	SODIUM FLUORIDE	Colgate-Palmolive Company	82ac5b9d-19e8-46ac-a195-c7d85f2967d5	2026-07-30	Warnings	Exact identifier application number: M021
Supersmile Professional Whitening TP Peppy Mint 1.4 oz	SODIUM MONOFLUOROPHOSPHATE	Robell Research, Inc	251264ea-20d2-be19-e063-6394a90aa5f6	2026-07-29	Warnings	Exact identifier application number: M021
Natural White Sensitive Enamel Guard Alpine Mint	SODIUM FLUORIDE	Lornamead Products	2e832204-ba2d-6dcb-e063-6394a90a5e6c	2026-07-29	Warnings	Exact identifier application number: M021
Natural White Radiant White	FLUORIDE	Lornamead Products	f0b62aaa-4983-4bd3-931e-f1a31b870f62	2026-07-29	Warnings	Exact identifier application number: M021
TP OW Pro Series Stain Prevention	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	76df52a3-b24c-4009-8137-fe644dabebf6	2026-07-29	Warnings	Exact identifier application number: M021
Colgate Kids Cavity Protection	SODIUM FLUORIDE	Colgate-Palmolive Company	f0e68196-8566-443b-9cc8-b57d5c001558	2026-07-29	Warnings	Exact identifier application number: M021
TP OW Pro Series Vividly Fresh	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	f0551acf-c4d6-4d49-ae9c-4aeaeb99a700	2026-07-29	Warnings	Exact identifier application number: M021
Colgate MaxFresh with Whitening KnockOut Fluoride	SODIUM FLUORIDE	Colgate-Palmolive Company	92079d13-3b66-42b7-9990-2727a489b6f6	2026-07-28	Warnings	Exact identifier application number: M021
BIO SPECTRA ATTITUDE	SODIUM FLUORIDE	9055-7588 Quebec Inc. DBA Attitude	7d04d050-b283-4fce-b1e9-e695b70363f9	2026-07-27	Warnings	Exact identifier application number: M021
COLGATE OPTIC WHITE ADVANCED OXYGENATING WHITE	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	cd805999-86e4-4f6c-9889-fa9a2227d526	2026-07-24	Warnings	Exact identifier application number: M021
COLGATE Baking Soda and Peroxide Whitening Brisk Mint	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	913a2cd6-b6a8-4069-979f-3c696a9bfdf0	2026-07-24	Warnings	Exact identifier application number: M021
COLGATE OPTIC WHITE PURPLE	SODIUM FLUORIDE	Colgate-Palmolive Company	16e9b303-fc2a-451a-adc7-dcb10fc0e6f8	2026-07-23	Warnings	Exact identifier application number: M021
Orajel Kids Superman	ANTICAVITY TOOTHPASTE	Church & Dwight Co., Inc.	2b47af33-32d4-7c06-e063-6394a90a2f33	2026-07-23	Warnings	Exact identifier application number: M021

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313029	sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse	PSN	98a8cee8-9f3c-4a4a-89f8-72e1f1b06796	5
313029	sodium fluoride 0.2 MG/ML Mouthwash	SCD	98a8cee8-9f3c-4a4a-89f8-72e1f1b06796	5
313029	sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral Rinse	SY	98a8cee8-9f3c-4a4a-89f8-72e1f1b06796	5
313029	sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse	SY	98a8cee8-9f3c-4a4a-89f8-72e1f1b06796	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
58578-0517-1	58578051701	1 BOTTLE in 1 BOX (58578-0517-1) / 473 mL in 1 BOTTLE	1 bottle	2024-01-01	No	No	Current
58578-0517-2	58578051702	2 BOTTLE in 1 PACKAGE (58578-0517-2) / 946 mL in 1 BOTTLE	2 bottle	2024-01-01	No	No	Current
58578-0517-3	58578051703	3 BOTTLE in 1 PACKAGE (58578-0517-3) / 946 mL in 1 BOTTLE	3 bottle	2024-01-01	No	No	Current
58578-0517-4	58578051704	946 mL in 1 BOTTLE (58578-0517-4)	946 ml	2024-01-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ClōSYS ® Silver ® Anticavity Fluoride Rinse	Rowpar Pharmaceuticals, Inc.	2026-04-01	HUMAN OTC DRUG LABEL	5