Anticavity Fluoride Rinse

Product NDC
59779-163
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 firm2026-10-16

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 22 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACT Restoring Anticavity Fluoride Cool MintSODIUM FLUORIDEChattem, Inc.ef63e193-5804-4b35-bae7-cad29cf4e8bc2026-01-12WarningsExact identifier
application number: M021
Prime Tooth Care BlueberrySODIUM FLUORIDEPrime Tooth Care LLC86642110-4572-4b8b-88f1-8d25fe05701e2026-01-09WarningsExact identifier
application number: M021
Prime Tooth Care Juicy PeachSODIUM FLUORIDEPrime Tooth Care LLC142f1610-3494-459f-a956-760e82169b872026-01-09WarningsExact identifier
application number: M021
Prime Tooth Care Coconut WhipSODIUM FLUORIDEPrime Tooth Care LLC55e95657-9415-4d9c-ac9b-d021aa14e64d2026-01-09WarningsExact identifier
application number: M021
Prime Tooth Care Hami MelonSODIUM FLUORIDEPrime Tooth Care LLC0028f88d-a9fe-4cfa-a6c6-168f9689b5f62026-01-09WarningsExact identifier
application number: M021
Prime Tooth Care Mango SmoothieSODIUM FLUORIDEPrime Tooth Care LLC2f2cf851-2edc-4aaf-9083-c37bc58547de2026-01-09WarningsExact identifier
application number: M021
Prime Tooth Care StrawberriesSODIUM FLUORIDEPrime Tooth Care LLC7b4328bd-5d2d-40ca-8322-5e818e1babf92026-01-09WarningsExact identifier
application number: M021
Prime Tooth Care Summer WatermelonSODIUM FLUORIDEPrime Tooth Care LLCb7c731a1-80e7-4571-a568-db0290a720c12026-01-09WarningsExact identifier
application number: M021
Kids Prime Pediatric Dental Group Anticavity for KidsSODIUM FLUORIDEPrime Tooth Care LLC93259174-447d-4f7a-8e55-990eb8da51512026-01-09WarningsExact identifier
application number: M021
Crest 3D White Brilliance Pro Enamel ProtectSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf32d5708-8cb1-6499-e053-2995a90ac6322026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Advanced Complete Care Anticavity FluorideSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf3a644c0-da04-276d-e053-2a95a90abf272026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Densify Active RepairSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4487d78-1da8-3f33-e053-2a95a90a6d922026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Densify Sensitive CareSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf435c1fe-7fbb-1b25-e053-2995a90aca112026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Densify Pro Intensive RepairSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf45c9c89-f294-deca-e053-2a95a90ae5572026-01-08WarningsExact identifier
application number: M021
Crest Pro-health Gum Detoxify Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf49a00de-b16a-66e6-e053-2995a90aedc62026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Gum Detoxify Gentle WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf49a7dc7-77f3-3911-e053-2a95a90ad55c2026-01-08WarningsExact identifier
application number: M021
Crest Complete Multi-Benefit Whitening plus Cinnamon ExpressionsSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company961295a6-79ae-44b1-e053-2995a90a61302026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Enamel Repair and Gum Intensive CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4c2118d-1216-d0d0-e053-2995a90a70882026-01-08WarningsExact identifier
application number: M021
Crest 3D White CharcoalSODIUM FLUORIDEProcter & Gamble Manfuacturing Company96247083-39e9-7ca7-e053-2995a90a75d02026-01-08WarningsExact identifier
application number: M021
Crest 3D White Advanced Express WhiteSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf4c2d5aa-b0e6-7068-e053-2995a90ae90c2026-01-08WarningsExact 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
59779-163-86597790163861000 mL in 1 PACKAGE (59779-163-86) 1000 ml2008-09-150000-00-00NoNoCurrent