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

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 Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui240698

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

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