Binaca Fluoride Anticavity Mouthwash

Product NDC
64893-500
11-digit product format
648930500
Labeler code
64893
Product ID
64893-500_7fff3c11-b0a8-4e66-8b31-0231b4be1b66
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
LIQUID
Route
DENTAL
Labeler
Dr. Fresh, LLC
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-09-02
Marketing end
2021-11-30
Substance
SODIUM FLUORIDE
Active strength
0 mg/mL
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct64893-500DDiscontinued by firm2026-10-05
excluded packagepackage64893-50064893-500-00DDiscontinued by firm2026-10-05

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 packagepackage64893-500-00d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64893-500-00f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64893-500-002ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64893-500-00a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64893-500-00cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64893-500-00cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64893-500-00302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64893-500-00ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64893-500-000efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64893-500-00ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64893-500-00367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64893-500-00557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64893-500-002021-09-27C16284748780-1c7ccaba7-12c3-fd44-e053-dadaa90aa01bBinaca Fluoride Anticavity Mouthwash
64893-500-002021-07-23C16284748780-1c7ccaba7-12c3-fd44-e053-dadaa90aa01bBinaca Fluoride Anticavity Mouthwash

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7BINACA FLUORIDE ANTICAVITY MOUTHWASH (SODIUM FLUORIDE) LIQUID [DR. FRESH, INC.]2
SODIUM CATIONACTIVE MOIETYLYR4M0NH37BINACA FLUORIDE ANTICAVITY MOUTHWASH (SODIUM FLUORIDE) LIQUID [DR. FRESH, INC.]2
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9BINACA FLUORIDE ANTICAVITY MOUTHWASH (SODIUM FLUORIDE) LIQUID [DR. FRESH, INC.]2
CALCIUM LACTATEINACTIVE INGREDIENT2URQ2N32W3BINACA FLUORIDE ANTICAVITY MOUTHWASH (SODIUM FLUORIDE) LIQUID [DR. FRESH, INC.]2
CETYLPYRIDINIUM CHLORIDEINACTIVE INGREDIENTD9OM4SK49PBINACA FLUORIDE ANTICAVITY MOUTHWASH (SODIUM FLUORIDE) LIQUID [DR. FRESH, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPBINACA FLUORIDE ANTICAVITY MOUTHWASH (SODIUM FLUORIDE) LIQUID [DR. FRESH, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBINACA FLUORIDE ANTICAVITY MOUTHWASH (SODIUM FLUORIDE) LIQUID [DR. FRESH, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBINACA FLUORIDE ANTICAVITY MOUTHWASH (SODIUM FLUORIDE) LIQUID [DR. FRESH, INC.]2
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BBINACA FLUORIDE ANTICAVITY MOUTHWASH (SODIUM FLUORIDE) LIQUID [DR. FRESH, INC.]2
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2BINACA FLUORIDE ANTICAVITY MOUTHWASH (SODIUM FLUORIDE) LIQUID [DR. FRESH, INC.]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYBINACA FLUORIDE ANTICAVITY MOUTHWASH (SODIUM FLUORIDE) LIQUID [DR. FRESH, INC.]2
SORBITOLINACTIVE INGREDIENT506T60A25RBINACA FLUORIDE ANTICAVITY MOUTHWASH (SODIUM FLUORIDE) LIQUID [DR. FRESH, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RBINACA FLUORIDE ANTICAVITY MOUTHWASH (SODIUM FLUORIDE) LIQUID [DR. FRESH, INC.]2
XYLITOLINACTIVE INGREDIENTVCQ006KQ1EBINACA FLUORIDE ANTICAVITY MOUTHWASH (SODIUM FLUORIDE) LIQUID [DR. FRESH, INC.]2
ZINC GLUCONATEINACTIVE INGREDIENTU6WSN5SQ1ZBINACA FLUORIDE ANTICAVITY MOUTHWASH (SODIUM FLUORIDE) LIQUID [DR. FRESH, INC.]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64893-500-0064893050000473 mL in 1 TUBE (64893-500-00) 473 ml2010-09-022021-11-30NoNoCurrent