PRO-SYS

Product NDC
66975-778
11-digit product format
669750778
Labeler code
66975
Product ID
66975-778_4e5407aa-4a76-dac3-e063-6394a90a6f2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Nitrate, Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL; ORAL
Labeler
Benco Dental
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-12-01
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
5; 1.1 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PRO-SYS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE5 g/100g
SODIUM FLUORIDE1.1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRU45X2JN0Z, 8ZYQ1474W7
Rxcui637365

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66975-778-01PRO-SYS113 g in 1 TUBEPASTE, DENTIFRICE1137

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
637365potassium nitrate 5 % / sodium fluoride 1.1 % ToothpastePSN4c9c144a-f28e-756d-e063-6394a90a59717
637365potassium nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG ToothpasteSCD4c9c144a-f28e-756d-e063-6394a90a59717
637365K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG ToothpasteSY4c9c144a-f28e-756d-e063-6394a90a59717
637365Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG ToothpasteSY4c9c144a-f28e-756d-e063-6394a90a59717
637365potassium nitrate 5 % / sodium fluoride 1.1 % Gel ToothpasteSY4c9c144a-f28e-756d-e063-6394a90a59717

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66975-778-0166975077801113 g in 1 TUBE (66975-778-01) 113 g2025-12-01NoNoHistorical