Anticavity

Product NDC
41163-004
Requested package NDC
41163-004-77
11-digit product format
411630004
Labeler code
41163
Product ID
41163-004_d9342000-d393-44de-92ea-8da41007a548
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium fluoride
Dosage form
RINSE
Route
ORAL
Labeler
UNIF
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-08-17
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
0 mg/mL
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage41163-00441163-004-77DDiscontinued by firm2026-10-12

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 packagepackage41163-00441163-004-77DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-004ANTICAVITY (SODIUM FLUORIDE) RINSE [UNITED NATURAL FOODS, INC. DBA UNFI]13Legacy NDC20250302_b14aa494-840c-44ca-87b7-2d746dab740a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-004-7741163000477500 mL in 1 BOTTLE, PLASTIC (41163-004-77) 500 ml2011-08-170000-00-00NoNoCurrent