FDA.reportPublic FDA data

Anticavity

Product NDC
55910-163
11-digit product format
559100163
Labeler code
55910
Product ID
55910-163_4c0f0ffe-bed6-25e9-e063-6294a90a04dd
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Old East Main Co.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2006-05-13
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 packagepackage55910-16355910-163-86DDiscontinued by firm2026-10-20

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 · 1 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 packagepackage55910-16355910-163-86DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
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
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
64f3d92d-f58c-4bc2-8819-f91492221ddbAvailable 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
55910-163-85Anticavity250 mL in 1 BOTTLE, PLASTICMOUTHWASH25019
55910-163-86Anticavity1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100019

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-163ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [OLD EAST MAIN CO.]15Current NDC, Legacy NDC, 2 package rows20240918_64f3d92d-f58c-4bc2-8819-f91492221ddb.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 12 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Clean Breath PeppermintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company4f1ef07b-ee68-e6ae-e063-6394a90af5e52026-04-10WarningsExact identifier
application number: M021
Crest Clean Breath SpearmintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company4f20343e-6c03-48e8-e063-6294a90a8cdf2026-04-10WarningsExact identifier
application number: M021
Crest Clean Breath Smooth MintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company4f2042b4-8eae-5c2c-e063-6394a90a640c2026-04-10WarningsExact identifier
application number: M021
Crest 3D White Advanced Arctic Fresh with Stain-Blasting FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4ef4146d-6281-fe66-e063-6394a90a32c32026-04-09WarningsExact identifier
application number: M021
Crest 3D White Advanced Glamorous White with Stain-Blasting FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4ef5261e-9d2f-ae05-e063-6294a90a489a2026-04-09WarningsExact identifier
application number: M021
Crest 3D White Advanced Luminous Mint Daily Whitening UpkeepSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f0876d9-41c9-d891-e063-6394a90a1cbd2026-04-09WarningsExact identifier
application number: M021
Crest 3D White Advanced Charcoal with Stain-Blasting FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4ef57a05-b9f5-42f7-e063-6294a90a5d892026-04-09WarningsExact identifier
application number: M021
Crest 3D White Advanced Radiant Mint with Stain Blasting FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4ee26a82-16fd-f0fb-e063-6394a90a91d12026-04-09WarningsExact identifier
application number: M021
Crest 3D White Whitening Therapy Deep Clean CharcoalSODIUM FLUORIDEProcter & Gamble Manfuacturing Company812c1519-1a4b-2495-e053-2a91aa0a914a2026-04-09WarningsExact identifier
application number: M021
Crest 3D White Advanced Deep Clean with Stain-Blasting FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4ef4e7c2-1f58-59fc-e063-6294a90ad43b2026-04-08WarningsExact identifier
application number: M021
Anticavity mouth rinse Low-foaming Spearmint779 US VARIANT ANTICAVITY MOUTH RINSE LOW-FOAMING SPEARMINTDyson Technology Limited4ef669b9-defe-8965-e063-6394a90ab3352026-04-08WarningsExact identifier
application number: M021
Crest 3D White Advanced Radiant MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf5c89efc-5fa0-2a05-e053-2a95a90a7b9c2026-04-07WarningsExact identifier
application number: M021
Crest 3D White Advanced CharcoalSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf4eb8111-53da-17ae-e053-2a95a90a11272026-04-07WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEADUSA Distribution, LLC35385ada-bd8d-4d38-9587-0256885f749f2026-04-07Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEADUSA Distribution, LLCcf0c8b48-0d1c-406a-a67d-7d16187d38d82026-04-07Warnings, Adverse reactionsExact identifier
application number: M021
Crest 3D White Arctic FreshSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyfa08a877-b9e5-4eba-b832-3a28f4f3f83c2026-04-07WarningsExact identifier
application number: M021
Anticavity FluorideSODIUM FLUORIDEFamily Dollar (FAMILY WELLNESS)63c4c0e9-84b1-4076-bdf4-7e9543b2cf462026-04-01WarningsExact identifier
application number: M021
CloSYS Silver Sensitive Mouth Rinse Fluoride RinseSODIUM FLUORIDERowpar Pharmaceuticals, Inc.98a8cee8-9f3c-4a4a-89f8-72e1f1b067962026-04-01WarningsExact identifier
application number: M021
CloSYSSODIUM FLUORIDERowpar Pharmaceuticals, Inc.5f87abb7-0e9d-6369-e053-2a91aa0a24112026-03-31WarningsExact identifier
application number: M021
Crest Clean Breath SpearmintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company4e544d09-0cf3-f0c7-e063-6394a90a23692026-03-31WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN64f3d92d-f58c-4bc2-8819-f91492221ddb19
313029sodium fluoride 0.2 MG/ML MouthwashSCD64f3d92d-f58c-4bc2-8819-f91492221ddb19
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY64f3d92d-f58c-4bc2-8819-f91492221ddb19
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY64f3d92d-f58c-4bc2-8819-f91492221ddb19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-163-8555910016385250 mL in 1 BOTTLE, PLASTIC (55910-163-85) 250 ml2025-09-09NoNoCurrent
55910-163-86559100163861000 mL in 1 BOTTLE, PLASTIC (55910-163-86) 1000 ml2006-05-130000-00-00NoNoCurrent