Anticavity Fluoride Rinse

Product NDC
59779-163
Requested package NDC
59779-163-77
11-digit product format
597790163
Labeler code
59779
Product ID
59779-163_4a9333a3-a8d6-0dcd-e063-6294a90afdab
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
MOUTHWASH
Route
ORAL
Labeler
CVS Pharmacy, Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-09-15
Substance
SODIUM FLUORIDE
Active strength
.1 mg/mL
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59779-16359779-163-77DDiscontinued by firm2026-09-14

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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59779-16359779-163-77DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59779-16359779-163-77DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…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
Anticavity Fluoride Rinse
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.1 mg/mL

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
1038904Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b2f7490c-e2af-49df-b054-70fb4815f729Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-163-77Anticavity Fluoride Rinse500 mL in 1 BOTTLE, PLASTICMOUTHWASH50016
59779-163-86Anticavity Fluoride Rinse1000 mL in 1 PACKAGEMOUTHWASH100016

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [CVS PHARMACY, INC]2
FLUORIDE IONACTIVE MOIETYQ80VPU408OANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [CVS PHARMACY, INC]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [CVS PHARMACY, INC]2
EUCALYPTOLINACTIVE INGREDIENTRV6J6604TKANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [CVS PHARMACY, INC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [CVS PHARMACY, INC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [CVS PHARMACY, INC]2
MENTHOLINACTIVE INGREDIENTL7T10EIP3AANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [CVS PHARMACY, INC]2
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022YANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [CVS PHARMACY, INC]2
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [CVS PHARMACY, INC]2
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [CVS PHARMACY, INC]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [CVS PHARMACY, INC]2
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [CVS PHARMACY, INC]2
SORBITOLINACTIVE INGREDIENT506T60A25RANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [CVS PHARMACY, INC]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [CVS PHARMACY, INC]2
THYMOLINACTIVE INGREDIENT3J50XA376EANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [CVS PHARMACY, INC]2
WATERINACTIVE INGREDIENT059QF0KO0RANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [CVS PHARMACY, INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-163ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [CVS PHARMACY, INC]13Current NDC, Legacy NDC, 2 package rows20240807_b2f7490c-e2af-49df-b054-70fb4815f729.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 1 of 52 · 1,033 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZONSENToothpasteTOOTHPASTEWuhan Zonsen Medical Products Co., Ltd.5613faef-3469-569a-e063-6394a90ac32d2026-09-10WarningsExact identifier
application number: M021
TheraBreathSODIUM FLUORIDEChurch & Dwight Co., Inc.53c1086d-264b-9d00-e063-6394a90ad19d2026-09-09WarningsExact identifier
application number: M021
Opalescence Whitening Cool MintSODIUM FLUORIDEUltradent Products, Inc.44e7d0ed-3c37-5889-e063-6294a90afcca2026-09-09WarningsExact identifier
application number: M021
Opalescence WhiteningSODIUM FLUORIDEUltradent Products, Incd07f842e-b6f1-4ae1-b576-f542ecd02dd42026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence OriginalSODIUM FLUORIDEUltradent Products, Inc.5c3bf8fc-2e8f-4a58-bcbf-e47540072a492026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence CompleteOPAL BY OPALESCENCE COMPLETEUltradent Products, Inc.249cc46a-dad6-0345-e063-6394a90a44472026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh KnockoutSODIUM FLUORIDEColgate-Palmolive Company0ffbb3a9-7bfa-4f6a-aef3-fde327a410c92026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh CharcoalSODIUM FLUORIDEColgate-Palmolive Companyde3674f4-3ce6-47d5-8391-6ad6789d68d92026-09-09WarningsExact identifier
application number: M021
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Incef108fff-a79c-4e8d-8bf0-3fe567f93eb82026-09-08WarningsExact identifier
application number: M021
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Inc1a42cf2d-6c48-4e38-97bc-b6f2084bf39b2026-09-08WarningsExact identifier
application number: M021
Freshmint Premium Anticavity GelSODIUM FLUORIDENew World Imports, Incdfe564c1-2097-431d-93f0-cf423f2542482026-09-08WarningsExact identifier
application number: M021
Freshmint Anticavity FluorideSODIUM MONOFLUOROPHOSPHATENew World Imports, Inc5aff7e41-58cd-5ab8-e063-6294a90aa1c72026-09-08WarningsExact identifier
application number: M021
Colgate Optic White Advanced Sparkling WhiteSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companybc56603d-4190-48c1-b16e-3179a650cb392026-09-06WarningsExact identifier
application number: M021
Dentalclean Advanced ProSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda4d261dc8-b065-567f-e063-6294a90aa93f2026-09-04WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude54bd43c9-489d-4e6b-9031-90ec0e3c45162026-09-01WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude53c344e9-49f5-48aa-8309-1e15f80b80a02026-09-01WarningsExact identifier
application number: M021
UnpasteZERO WASTE FLUORIDE MINT TOOTH TABSAvespan LLC312ae88d-7ea4-b3e0-e063-6294a90a99e52026-09-01WarningsExact identifier
application number: M021
Dentalclean Regenerator Sensitive Dental Gel with FluorideSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda176aa3ed-e2a4-536d-e063-6294a90aa0972026-08-31WarningsExact identifier
application number: M021
Listerine Total Care Fresh Mint AnticavitySODIUM FLUORIDEKenvue Brands LLCb2ce66c3-dc48-47a5-a731-5550bc1946792026-08-28WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEYour Military Exchangescef74e9c-d3b5-4e92-9908-187be97b63ab2026-08-28Warnings, Adverse reactionsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038904sodium fluoride 0.0221 % (fluoride ion 0.01 % ) MouthwashPSNb2f7490c-e2af-49df-b054-70fb4815f72916
1038904sodium fluoride 0.221 MG/ML MouthwashSCDb2f7490c-e2af-49df-b054-70fb4815f72916
1038904sodium fluoride 0.0221 % (fluoride 0.01 % ) Oral RinseSYb2f7490c-e2af-49df-b054-70fb4815f72916

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-163-7759779016377500 mL in 1 BOTTLE, PLASTIC (59779-163-77) 500 ml2008-09-150000-00-00NoNoCurrent