CloSYS

Product NDC: 58578-0749
11-digit product format: 585780749
Labeler code: 58578
Product ID: 58578-0749_4aab2169-2fe1-4d9b-94a0-45724392e6bc
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium Fluoride
Dosage form: PASTE, DENTIFRICE
Route: DENTAL; ORAL
Labeler: Rowpar Pharmaceuticals, Inc.
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-10-20
Substance: SODIUM FLUORIDE
Active strength: 1.1 mg/g
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	58578-0749	58578-0749-3	D	Discontinued by firm		2026-10-21

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58578-0749	58578-0749-3	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58578-0749	58578-0749-3	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM FLUORIDE	1.1 mg/g

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
416783	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
5f87abb7-0e9d-6369-e053-2a91aa0a2411	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58578-0749-1	CloSYS	1 in 1 BOX	PASTE, DENTIFRICE	1	11
58578-0749-1	CloSYS	96 g in 1 TUBE	PASTE, DENTIFRICE	96	11
58578-0749-2	CloSYS	1 in 1 BOX	PASTE, DENTIFRICE	1	11
58578-0749-2	CloSYS	198 g in 1 TUBE	PASTE, DENTIFRICE	198	11
58578-0749-3	CloSYS	21 g in 1 TUBE	PASTE, DENTIFRICE	21	11
58578-0749-3	CloSYS	1 in 1 BOX	PASTE, DENTIFRICE	1	11
58578-0749-4	CloSYS	198 g in 1 TUBE	PASTE, DENTIFRICE	198	11
58578-0749-4	CloSYS	2 in 1 PACKAGE	PASTE, DENTIFRICE	2	11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58578-0749	CLOSYS (SODIUM FLUORIDE) PASTE, DENTIFRICE [ROWPAR PHARMACEUTICALS, INC.]	10	Current NDC, Legacy NDC, 8 package rows	20250523_5f87abb7-0e9d-6369-e053-2a91aa0a2411.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 16 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anticavity	SODIUM FLUORIDE	United Natural Foods, Inc. dba UNFI	dd6bf8df-1e28-4f61-b876-b9f1f8d5993a	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	United Natural Foods, Inc. dba UNFI	8283cea0-7b62-4796-8763-6654039664cd	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	United Natural Foods, Inc. dba UNFI	9d055fed-26d8-4827-a4cc-8c314514a6c3	2026-02-17	Warnings	Exact identifier application number: M021
Brush Buddies Crayola Color Changing ANTICAVITY FLUORIDE WATERMELON FLAVOR	SODIUM FLUORIDE	Ashtel Studios, Inc.	28d1b8c3-930f-4ac9-aa5a-b72b832bb77e	2026-02-17	Warnings	Exact identifier application number: M021
Anticavity Rinse	SODIUM FLUORIDE	Valu Merchandisers Company	088b95e6-30fd-4263-9fdc-57cd63385b71	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Valu Merchandisers Company	e31c1609-a1c3-4ed5-adfd-3cfa63205ec3	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	United Natural Foods, Inc. dba UNFI	3602c528-5f53-4d41-bf67-163149f52b35	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	United Natural Foods, Inc. dba UNFI	e696038c-182e-4325-9b90-87fe498d9f67	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Topco Associates LLC	3b04142a-4a65-45ba-a5a2-e62b0c47ec55	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Mouth Rinse	SODIUM FLUORIDE	Topco Associates LLC	c640adc0-e178-4b6a-af44-07d2f7da81d3	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Topco Associates LLC	f760f8f8-0c74-4a6e-b5c9-cc82b8758a45	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Alcohol-Free Anticavity	SODIUM FLUORIDE	Topco Associates LLC	ade7dcb2-b4e2-4cef-b9a7-469867ead68a	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Oral Antivavity	SODIUM FLUORIDE	Topco Associates LLC	84b30711-a7e5-4189-895a-a7989f05591c	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity fluoride rinse	SODIUM FLUORIDE	Topco Associates LLC	c3f2e952-a8d5-4e9d-a5c6-09e4f2544179	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Topco Associates LLC	a9b8b2fe-0a60-4f65-b6f6-aae8509c919f	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M021
Salivea	FLUORIDE TOOTHPASTE	Laclede, Inc.	4abb0f80-d87d-730f-e063-6294a90a15f7	2026-02-13	Warnings	Exact identifier application number: M021
Alcohol-Free Anticavity	SODIUM FLUORIDE	Your Military Exchanges	965911c3-7aa8-4830-8269-6aa5d526ee73	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M021
Mouth Rinse	SODIUM FLUORIDE	Walgreen Co.	eae87899-3eba-4d50-bc31-9eaf54ff9e00	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M021
Crest Complete plus Whitening plus Scope Outlast	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	960e0e3e-10e8-7426-e053-2a95a90a5b02	2026-02-12	Warnings	Exact identifier application number: M021
Crest Fresh and White	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	8693fa6d-e9c9-4cb7-bd3d-8ad87a7bb77e	2026-02-12	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
416783	sodium fluoride 0.24 % Toothpaste	PSN	5f87abb7-0e9d-6369-e053-2a91aa0a2411	11
416783	sodium fluoride 0.0024 MG/MG Toothpaste	SCD	5f87abb7-0e9d-6369-e053-2a91aa0a2411	11
416783	sodium fluoride 0.24 % (fluoride ion 0.13 % ) Toothpaste	SY	5f87abb7-0e9d-6369-e053-2a91aa0a2411	11
416783	sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	5f87abb7-0e9d-6369-e053-2a91aa0a2411	11
416783	sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	5f87abb7-0e9d-6369-e053-2a91aa0a2411	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58578-0749-1	58578074901	1 TUBE in 1 BOX (58578-0749-1) / 96 g in 1 TUBE	1 tube	2017-10-20	0000-00-00	No	No	Current
58578-0749-2	58578074902	1 TUBE in 1 BOX (58578-0749-2) / 198 g in 1 TUBE	1 tube	2017-10-20	0000-00-00	No	No	Current
58578-0749-3	58578074903	1 TUBE in 1 BOX (58578-0749-3) > 21 g in 1 TUBE	1 tube	2017-10-20	0000-00-00	No	No	Current
58578-0749-4	58578074904	2 TUBE in 1 PACKAGE (58578-0749-4) / 198 g in 1 TUBE	2 tube	2017-10-20		No	No	Current