Anticavity

Product NDC
55319-213
11-digit product format
553190213
Labeler code
55319
Product ID
55319-213_c34f44dc-6b6a-4941-a8ee-f5273fd9f031
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium fluoride
Dosage form
RINSE
Route
ORAL
Labeler
Family Dollar Servicesm Inc
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2005-02-23
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
0 mg/mL
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55319-213DDiscontinued by firm2026-10-12
excluded packagepackage55319-21355319-213-44DDiscontinued 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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55319-213-44d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55319-213-44f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55319-213-442ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55319-213-44a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55319-213-44cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55319-213-44cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55319-213-44302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55319-213-44ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55319-213-440efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55319-213-44ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55319-213-44367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55319-213-44557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7ANTICAVITY (SODIUM FLUORIDE) RINSE [FAMILY DOLLAR SERVICESM INC]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OANTICAVITY (SODIUM FLUORIDE) RINSE [FAMILY DOLLAR SERVICESM INC]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHANTICAVITY (SODIUM FLUORIDE) RINSE [FAMILY DOLLAR SERVICESM INC]1
CETYLPYRIDINIUM CHLORIDEINACTIVE INGREDIENTD9OM4SK49PANTICAVITY (SODIUM FLUORIDE) RINSE [FAMILY DOLLAR SERVICESM INC]1
EDETATE CALCIUM DISODIUM ANHYDROUSINACTIVE INGREDIENT8U5D034955ANTICAVITY (SODIUM FLUORIDE) RINSE [FAMILY DOLLAR SERVICESM INC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KANTICAVITY (SODIUM FLUORIDE) RINSE [FAMILY DOLLAR SERVICESM INC]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SANTICAVITY (SODIUM FLUORIDE) RINSE [FAMILY DOLLAR SERVICESM INC]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MANTICAVITY (SODIUM FLUORIDE) RINSE [FAMILY DOLLAR SERVICESM INC]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3AANTICAVITY (SODIUM FLUORIDE) RINSE [FAMILY DOLLAR SERVICESM INC]1
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022YANTICAVITY (SODIUM FLUORIDE) RINSE [FAMILY DOLLAR SERVICESM INC]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ANTICAVITY (SODIUM FLUORIDE) RINSE [FAMILY DOLLAR SERVICESM INC]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHANTICAVITY (SODIUM FLUORIDE) RINSE [FAMILY DOLLAR SERVICESM INC]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4ANTICAVITY (SODIUM FLUORIDE) RINSE [FAMILY DOLLAR SERVICESM INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ANTICAVITY (SODIUM FLUORIDE) RINSE [FAMILY DOLLAR SERVICESM INC]1
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYANTICAVITY (SODIUM FLUORIDE) RINSE [FAMILY DOLLAR SERVICESM INC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUANTICAVITY (SODIUM FLUORIDE) RINSE [FAMILY DOLLAR SERVICESM INC]1
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY37ANTICAVITY (SODIUM FLUORIDE) RINSE [FAMILY DOLLAR SERVICESM INC]1
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FANTICAVITY (SODIUM FLUORIDE) RINSE [FAMILY DOLLAR SERVICESM INC]1
SORBITOLINACTIVE INGREDIENT506T60A25RANTICAVITY (SODIUM FLUORIDE) RINSE [FAMILY DOLLAR SERVICESM INC]1
WATERINACTIVE INGREDIENT059QF0KO0RANTICAVITY (SODIUM FLUORIDE) RINSE [FAMILY DOLLAR SERVICESM INC]1