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 29 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Supersmile Professional Whitening TP Citrus BlastSODIUM MONOFLUOROPHOSPHATERobell Research, Inc25039552-c35d-a69d-e063-6394a90ab1032026-01-08WarningsExact identifier
application number: M021
Supersmile Professional Whitening TP Citrus BlastSODIUM MONOFLUOROPHOSPHATERobell Research, Inc2504686d-b053-51d0-e063-6394a90a789f2026-01-08WarningsExact identifier
application number: M021
Supersmile Professional Whitening TP Peppy Mint 8 ozSODIUM MONOFLUOROPHOSPHATERobell Research, Inc25121ebb-922b-719d-e063-6394a90a23d32026-01-08WarningsExact identifier
application number: M021
Crest Pro-health Gum Detoxify Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf498b727-c38c-1d67-e053-2995a90a0f112026-01-08WarningsExact identifier
application number: M021
DG health Sensitive Maximum StrengthPOTASSIUM NITRATE, SODIUM FLUORIDEDolgencorp, LLC81cd5d37-3751-625f-e053-2a91aa0a6dfd2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Advanced Glamorous WhiteSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf5b18988-68c7-40f9-e053-2995a90a22bc2026-01-08WarningsExact identifier
application number: M021
CVS Restore and Defend Sensitive WhiteningSTANNOUS FLUORIDECVS Pharmacy81b72da2-7f41-74ca-e053-2a91aa0a96462026-01-08WarningsExact identifier
application number: M021
Gum and Enamel RepairSTANNOUS FLUORIDECVSccad05d4-7f05-bebd-e053-2a95a90aa52c2026-01-08WarningsExact identifier
application number: M021
CVS Pharmacy Pro DefenseFLUORIDECVS Pharmacy445ec57e-dc3c-49a0-8ca9-4806fcdc03032026-01-08WarningsExact identifier
application number: M021
Gum DetoxifySTANNOUS FLUORIDEWalmartad3f645d-aaf9-2800-e053-2a95a90ab62f2026-01-08WarningsExact identifier
application number: M021
CVS Complete ProtectionSTANNOUS FLOURIDECVSb681b5e4-a0e1-8d0f-e053-2a95a90aa6722026-01-06WarningsExact identifier
application number: M021
Complete ProtectionSTANNOUS FLUORIDETarget03708e08-0189-b83d-e063-6394a90a50e62026-01-06WarningsExact identifier
application number: M021
Brush Buddies Mouthwash 12oz Star Wars Saber Strike StrawberrySODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.4998c0e6-1de3-11cd-e063-6294a90acb6f2026-01-01WarningsExact identifier
application number: M021
Exceed Total Care Sensitive Spearmint Tooth PolishPOTASSIUM NITRATE AND SODIUM FLUORIDEMelaleuca, Incdc620d3f-880f-df05-e053-2995a90a84092025-12-31WarningsExact identifier
application number: M021
Exceed Total Care Sensitive Peppermint Tooth PolishPOTASSIUM NITRATE AND SODIUM FLUORIDEMelaleuca, Inced2179a4-3d19-6481-e053-2995a90ad6552025-12-31WarningsExact identifier
application number: M021
Koala Pals BerryliciousSODIUM FLUORIDEMelaleuca, Inc.6624be86-c9a8-53b8-e053-2a91aa0a87ef2025-12-31WarningsExact identifier
application number: M021
Whitening Tooth PolishSODIUM FLUORIDEMelaleuca, Inc.6893405a-a2c4-068e-e053-2a91aa0ae5b12025-12-31WarningsExact identifier
application number: M021
Gel 1100 MintSODIUM FLUORIDEDental Alliance Holdings LLCf125fb04-5045-5367-e053-2a95a90aa73b2025-12-29WarningsExact identifier
application number: M021
Gracie Square Hospital AmenitySODIUM MONOFLUOROPHOSPHATEASP Global, LLc89d81053-6950-465e-a5b1-cbf841d7afcb2025-12-29WarningsExact identifier
application number: M021
CloSYS Fluoride RinseSODIUM FLUORIDERowpar Pharmaceuticals, Inc.1a994f24-99ee-4b27-aab0-e816931a22c82025-12-23WarningsExact 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