PRO-SYS

Product NDC
66975-720
11-digit product format
669750720
Labeler code
66975
Product ID
66975-720_4e53a23c-7977-632d-e063-6394a90a7ae6
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL; ORAL
Labeler
Benco Dental
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-01
Substance
SODIUM FLUORIDE
Active strength
.11 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
SODIUM FLUORIDE.11 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui416783

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66975-720-01PRO-SYS113.4 g in 1 TUBEPASTE, DENTIFRICE113.41
66975-720-02PRO-SYS24 g in 1 TUBEPASTE, DENTIFRICE241

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN4e539cb2-bcbd-95fc-e063-6294a90a21211
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD4e539cb2-bcbd-95fc-e063-6294a90a21211
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY4e539cb2-bcbd-95fc-e063-6294a90a21211
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY4e539cb2-bcbd-95fc-e063-6294a90a21211
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY4e539cb2-bcbd-95fc-e063-6294a90a21211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66975-720-0166975072001113.4 g in 1 TUBE (66975-720-01) 113.4 g2025-12-01NoNoHistorical
66975-720-026697507200224 g in 1 TUBE (66975-720-02) 24 g2025-12-01NoNoHistorical