Anticavity Fluoride Rinse

Product NDC
36800-213
11-digit product format
368000213
Labeler code
36800
Product ID
36800-213_4ab8141c-7913-66fb-e063-6394a90aa357
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Topco Associates LLC
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2003-10-20
Substance
SODIUM FLUORIDE
Active strength
.2 mg/mL
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
Anticavity Fluoride Rinse
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.2 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
240698Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f760f8f8-0c74-4a6e-b5c9-cc82b8758a45Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-213-44Anticavity Fluoride Rinse532 mL in 1 BOTTLE, PLASTICMOUTHWASH53216

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
CETYLPYRIDINIUM CHLORIDEINACTIVE INGREDIENTD9OM4SK49PANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3AANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022YANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY37ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
SORBITOLINACTIVE INGREDIENT506T60A25RANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-213ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES, LLC]15Current NDC, Legacy NDC, 1 package rows20250406_f760f8f8-0c74-4a6e-b5c9-cc82b8758a45.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
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSNf760f8f8-0c74-4a6e-b5c9-cc82b8758a4516
240698sodium fluoride 0.5 MG/ML MouthwashSCDf760f8f8-0c74-4a6e-b5c9-cc82b8758a4516
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSYf760f8f8-0c74-4a6e-b5c9-cc82b8758a4516

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-213-4436800021344532 mL in 1 BOTTLE, PLASTIC (36800-213-44) 532 ml2003-10-200000-00-00NoNoCurrent