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
SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength
5.8; 57.5 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

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
SODIUM FLUORIDE5.8 mg/mL
POTASSIUM NITRATE57.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup
RU45X2JN0ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
637365Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7a051d80-879d-4995-96ef-77b60dad26b7Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium Fluoride and Potassium NitrateSODIUM FLUORIDE AND POTASSIUM NITRATEWestminster Pharmaceuticals, LLC7a051d80-879d-4995-96ef-77b60dad26b72024-04-18Warnings, Adverse reactionsExact identifier
ndc (product): 69367-318

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