FDA.reportPublic FDA data

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 UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
RU45X2JN0ZInternal UNII lookup
8ZYQ1474W7Internal 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
4c9c144a-f28e-756d-e063-6394a90a5971Available on FDA.report

DailyMed Package Descriptions#

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

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
PRO-SYSPOTASSIUM NITRATE, SODIUM FLUORIDEBenco Dental4c9c144a-f28e-756d-e063-6394a90a59712026-03-31WarningsExact identifier
ndc (product): 66975-778

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 g2025-12-01NoNoCurrent