Sodium Fluoride 5000 PPM

Product NDC
69367-312
11-digit product format
693670312
Labeler code
69367
Product ID
69367-312_f227132c-6257-4245-b8e0-7de78c15c201
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE
Route
DENTAL
Labeler
Westminster Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2021-06-16
Substance
SODIUM FLUORIDE
Active strength
6 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 5000 PPM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE6 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui392038

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69367-312-01Sodium Fluoride 5000 PPM100 mL in 1 TUBEPASTE1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-312-01ML - Milliliter69367-31290285fed-8d3e-4487-b2bb-4c73d825ea8c12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-312SODIUM FLUORIDE 5000 PPM (SODIUM FLUORIDE) PASTE [WESTMINSTER PHARMACEUTICALS, LLC]9Current NDC, Legacy NDC, 1 package rows20250417_56efb346-c715-463d-9260-f7fcfbd2b70f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
392038sodium fluoride 1.1 % ToothpastePSN56efb346-c715-463d-9260-f7fcfbd2b70f9
392038sodium fluoride 0.011 MG/MG ToothpasteSCD56efb346-c715-463d-9260-f7fcfbd2b70f9
392038sodium fluoride 1.1 % (fluoride ion 0.5 % ) ToothpasteSY56efb346-c715-463d-9260-f7fcfbd2b70f9
392038sodium fluoride 1.1 % Dental GelSY56efb346-c715-463d-9260-f7fcfbd2b70f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69367-312-0169367031201100 mL in 1 TUBE (69367-312-01) 100 ml2021-06-160000-00-00NoNoCurrent