FDA.reportPublic FDA data

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
IngredientStrength
SODIUM FLUORIDE.02 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
98a8cee8-9f3c-4a4a-89f8-72e1f1b06796Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58578-0517-1CloSYS Silver Sensitive Mouth RinseFluoride Rinse473 mL in 1 BOTTLERINSE4735
58578-0517-1CloSYS Silver Sensitive Mouth RinseFluoride Rinse1 in 1 BOXRINSE15
58578-0517-2CloSYS Silver Sensitive Mouth RinseFluoride Rinse2 in 1 PACKAGERINSE25
58578-0517-2CloSYS Silver Sensitive Mouth RinseFluoride Rinse946 mL in 1 BOTTLERINSE9465
58578-0517-3CloSYS Silver Sensitive Mouth RinseFluoride Rinse946 mL in 1 BOTTLERINSE9465
58578-0517-3CloSYS Silver Sensitive Mouth RinseFluoride Rinse3 in 1 PACKAGERINSE35
58578-0517-4CloSYS Silver Sensitive Mouth RinseFluoride Rinse946 mL in 1 BOTTLERINSE9465

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58578-0517CLOSYS SILVER SENSITIVE MOUTH RINSE FLUORIDE RINSE (SODIUM FLUORIDE) RINSE [ROWPAR PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 7 package rows20250523_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 2 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate MaxFresh Clean MintSODIUM FLUORIDEColgate-Palmolive Company7cb85fc4-573b-45d7-a430-f2fd17320c432026-08-26WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PRO SERIES HIGH IMPACT WHITESODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company8b210b6c-b712-4f14-906c-306922573a262026-08-26WarningsExact identifier
application number: M021
Crest Pro-Health Sensitivity ReliefSODIUM FLUORIDE AND POTASSIUM NITRATEThe Procter & Gamble Manufacturing Company59dff762-7f66-8bdc-e063-6294a90a9f182026-08-25WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDENice-Pak Products, LLCc71d4064-f938-477b-9346-eb38be65390d2026-08-25Warnings, Adverse reactionsExact identifier
application number: M021
AIM Whitening with Baking SodaSODIUM FLUORIDEChurch & Dwight Co., Inc.1d0fd0b4-33ba-5764-e054-00144ff88e882026-08-25WarningsExact identifier
application number: M021
OPTIC WHITE PRO SERIES VIBRANT CLEANSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyb1ada157-a9a0-4eec-83a2-6e448d7f12dc2026-08-21WarningsExact identifier
application number: M021
Therabreath WhiteningSODIUM FLUORIDEChurch & Dwight Co., Inc.3ba04b55-38f9-76f3-e063-6394a90a3c032026-08-21WarningsExact identifier
application number: M021
Therabreath Deep CleanSTANNOUS FLUORIDEChurch & Dwight Co., Inc.3c372f26-e0c4-0659-e063-6294a90ae9f92026-08-21WarningsExact identifier
application number: M021
TheraBreathPOTASSIUM NITRATE, SODIUM FLUORIDEChurch & Dwight Co., Inc.4b812a38-f7cb-51c8-e063-6394a90ab82c2026-08-21WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEYour Military Exchangeseb95e0ca-a94c-41cb-9f54-6c64ed9a97332026-08-21Warnings, Adverse reactionsExact identifier
application number: M021
Pop On Toothpaste.POP ON TOOTHPASTE.POPONSMILES,LLC4a0edab5-ae36-91b5-e063-6294a90aa6852026-08-21WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PRO SERIES EXPRESS WHITESODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company188dc3ac-64c9-438e-858b-846f725c6ea02026-08-21WarningsExact identifier
application number: M021
COLGATE TOTAL ACTIVE PREVENTION CLEAN MINTSTANNOUS FLUORIDEColgate-Palmolive Company178d4535-fa57-4b53-b1f8-5c591f2ea9e72026-08-21WarningsExact identifier
application number: M021
freshSTART Anticavity fluoride toothpaste.ANTICAVITY FLUORIDE TOOTHPASTEGuangzhou Xinuo Technology Co., Ltd.596432d5-3541-6dff-e063-6294a90a9d422026-08-19WarningsExact identifier
application number: M021
Colgate Sensitive ProRelief WhiteningSTANNOUS FLUORIDEColgate-Palmolive Company8d9d485e-6efb-4bca-a779-9e8b0aeed14c2026-08-18WarningsExact identifier
application number: M021
SprinJene NaturalSODIUM MONOFLUOROPHOSPHATEHealth and Natural Beauty USA Corpe64cecc3-0845-4bdf-a449-d78248791ccf2026-08-17WarningsExact identifier
application number: M021
ATOMY ANTICAVITY TOOTHSODIUM MONOFLUOROPHOSPHATEATOMY CO., LTD.592caccc-e3a9-9c66-e063-6394a90a26e32026-08-16WarningsExact identifier
application number: M021
SprinJene Health BoostSODIUM MONOFLUOROPHOSPHATEHealth and Natural Beauty USA Corp9be87bcd-403a-4d7e-8ded-9833249565d12026-08-14WarningsExact identifier
application number: M021
SprinJene Fresh BoostSODIUM FLUORIDEHealth and Natural Beauty USA Corp919f6f51-6c43-4f1c-9bc7-029bf76c0e682026-08-14WarningsExact identifier
application number: M021
SprinJene Natural Sensitivity ReliefSODIUM MONOFLUOROPHOSPHATE AND POTASSIUM NITRATEHealth and Natural Beauty USA Corp32cc5bc2-60c9-4cb4-acde-485ae494aba22026-08-14WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN98a8cee8-9f3c-4a4a-89f8-72e1f1b067965
313029sodium fluoride 0.2 MG/ML MouthwashSCD98a8cee8-9f3c-4a4a-89f8-72e1f1b067965
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY98a8cee8-9f3c-4a4a-89f8-72e1f1b067965
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY98a8cee8-9f3c-4a4a-89f8-72e1f1b067965

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58578-0517-1585780517011 BOTTLE in 1 BOX (58578-0517-1) / 473 mL in 1 BOTTLE1 bottle2024-01-01NoNoCurrent
58578-0517-2585780517022 BOTTLE in 1 PACKAGE (58578-0517-2) / 946 mL in 1 BOTTLE2 bottle2024-01-01NoNoCurrent
58578-0517-3585780517033 BOTTLE in 1 PACKAGE (58578-0517-3) / 946 mL in 1 BOTTLE3 bottle2024-01-01NoNoCurrent
58578-0517-458578051704946 mL in 1 BOTTLE (58578-0517-4) 946 ml2024-01-01NoNoCurrent