FDA.reportPublic FDA data

Sodium Fluoride and Potassium Nitrate

Product NDC
69367-318
11-digit product format
693670318
Labeler code
69367
Product ID
69367-318_0c9c8462-f962-4615-8649-dea8e1ecb498
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride and Potassium Nitrate
Dosage form
GEL
Route
DENTAL
Labeler
Westminster Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-06-15
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
57.5; 5.8 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sodium Fluoride and Potassium Nitrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE57.5 mg/mL
SODIUM FLUORIDE5.8 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRU45X2JN0Z, 8ZYQ1474W7
Rxcui637365

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69367-318-01Sodium Fluoride and Potassium Nitrate100 mL in 1 TUBEGEL1007
69367-318-01Sodium Fluoride and Potassium Nitrate1 in 1 CARTONGEL17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-318-01ML - Milliliter69367-318d8d9923e-3e22-4c73-8075-5f147f5f7ae612024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-318SODIUM FLUORIDE AND POTASSIUM NITRATE GEL [WESTMINSTER PHARMACEUTICALS, LLC]7Current NDC, Legacy NDC, 2 package rows20240420_7a051d80-879d-4995-96ef-77b60dad26b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
637365potassium nitrate 5 % / sodium fluoride 1.1 % ToothpastePSN7a051d80-879d-4995-96ef-77b60dad26b77
637365potassium nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG ToothpasteSCD7a051d80-879d-4995-96ef-77b60dad26b77
637365K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG ToothpasteSY7a051d80-879d-4995-96ef-77b60dad26b77
637365Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG ToothpasteSY7a051d80-879d-4995-96ef-77b60dad26b77
637365potassium nitrate 5 % / sodium fluoride 1.1 % Gel ToothpasteSY7a051d80-879d-4995-96ef-77b60dad26b77

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69367-318-01693670318011 TUBE in 1 CARTON (69367-318-01) / 100 mL in 1 TUBE1 tube2022-06-150000-00-00NoNoCurrent