FDA.reportPublic FDA data

Anticavity

Product NDC
55910-030
11-digit product format
559100030
Labeler code
55910
Product ID
55910-030_4c0e8e2a-79a2-8052-e063-6294a90a4786
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium fluoride
Dosage form
RINSE
Route
ORAL
Labeler
Old East Main Co.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-02-24
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
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
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-030-44Anticavity532 mL in 1 BOTTLE, PLASTICRINSE53227
55910-030-77Anticavity500 mL in 1 BOTTLE, PLASTICRINSE50027

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7ANTICAVITY (SODIUM FLUORIDE) RINSE [DOLGENCORP, LLC]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OANTICAVITY (SODIUM FLUORIDE) RINSE [DOLGENCORP, LLC]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHANTICAVITY (SODIUM FLUORIDE) RINSE [DOLGENCORP, LLC]1
CETYLPYRIDINIUM CHLORIDEINACTIVE INGREDIENTD9OM4SK49PANTICAVITY (SODIUM FLUORIDE) RINSE [DOLGENCORP, LLC]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LANTICAVITY (SODIUM FLUORIDE) RINSE [DOLGENCORP, LLC]1
EDETATE CALCIUM DISODIUM ANHYDROUSINACTIVE INGREDIENT8U5D034955ANTICAVITY (SODIUM FLUORIDE) RINSE [DOLGENCORP, LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KANTICAVITY (SODIUM FLUORIDE) RINSE [DOLGENCORP, LLC]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ANTICAVITY (SODIUM FLUORIDE) RINSE [DOLGENCORP, LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HANTICAVITY (SODIUM FLUORIDE) RINSE [DOLGENCORP, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ANTICAVITY (SODIUM FLUORIDE) RINSE [DOLGENCORP, LLC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYANTICAVITY (SODIUM FLUORIDE) RINSE [DOLGENCORP, LLC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUANTICAVITY (SODIUM FLUORIDE) RINSE [DOLGENCORP, LLC]1
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY37ANTICAVITY (SODIUM FLUORIDE) RINSE [DOLGENCORP, LLC]1
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FANTICAVITY (SODIUM FLUORIDE) RINSE [DOLGENCORP, LLC]1
SORBITOLINACTIVE INGREDIENT506T60A25RANTICAVITY (SODIUM FLUORIDE) RINSE [DOLGENCORP, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RANTICAVITY (SODIUM FLUORIDE) RINSE [DOLGENCORP, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-030ANTICAVITY (SODIUM FLUORIDE) RINSE [OLD EAST MAIN CO]26Current NDC, Legacy NDC, 2 package rows20250406_f8036e2e-7541-4922-92b9-0d8319f7b64c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSNf8036e2e-7541-4922-92b9-0d8319f7b64c27
240698sodium fluoride 0.5 MG/ML MouthwashSCDf8036e2e-7541-4922-92b9-0d8319f7b64c27
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSYf8036e2e-7541-4922-92b9-0d8319f7b64c27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-030-4455910003044532 mL in 1 BOTTLE, PLASTIC532 mlHistorical
55910-030-7755910003077500 mL in 1 BOTTLE, PLASTIC (55910-030-77) 500 ml2015-02-240000-00-00NoNoCurrent