FLUORIDEX

Product NDC
59883-030
11-digit product format
598830030
Labeler code
59883
Product ID
59883-030_020d58ac-51bc-19a2-e063-6394a90aedf6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
DENT-MAT HOLDINGS, LLC.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2017-01-06
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
50; 5 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
FLUORIDEX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE50 mg/g
SODIUM FLUORIDE5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRU45X2JN0Z, 8ZYQ1474W7
Rxcui637365, 847014

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59883-030-04FLUORIDEX1 in 1 BOXPASTE, DENTIFRICE13
59883-030-04FLUORIDEX112 g in 1 TUBEPASTE, DENTIFRICE1123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59883-030FLUORIDEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DENT-MAT HOLDINGS, LLC.]3Current NDC, Legacy NDC, 2 package rows20230804_6050ef4d-50e8-55d7-e053-2991aa0ad076.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
847014Fluoridex Daily Defense Sensitivity 5 % / 1.1 % ToothpastePSN6050ef4d-50e8-55d7-e053-2991aa0ad0763
637365potassium nitrate 5 % / sodium fluoride 1.1 % ToothpastePSN6050ef4d-50e8-55d7-e053-2991aa0ad0763
847014potassium nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG Toothpaste [Fluoridex Daily Defense Sensitivity]SBD6050ef4d-50e8-55d7-e053-2991aa0ad0763
637365potassium nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG ToothpasteSCD6050ef4d-50e8-55d7-e053-2991aa0ad0763
847014Fluoridex Daily Defense Sensitivity (potassium nitrate 5 % / sodium fluoride 1.1 % ) ToothpasteSY6050ef4d-50e8-55d7-e053-2991aa0ad0763
847014Fluoridex Daily Defense Sensitivity ToothpasteSY6050ef4d-50e8-55d7-e053-2991aa0ad0763
637365K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG ToothpasteSY6050ef4d-50e8-55d7-e053-2991aa0ad0763
847014K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG Toothpaste [Fluoridex Daily Defense Sensitivity]SY6050ef4d-50e8-55d7-e053-2991aa0ad0763
637365Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG ToothpasteSY6050ef4d-50e8-55d7-e053-2991aa0ad0763
847014Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG Toothpaste [Fluoridex Daily Defense Sensitivity]SY6050ef4d-50e8-55d7-e053-2991aa0ad0763
637365potassium nitrate 5 % / sodium fluoride 1.1 % Gel ToothpasteSY6050ef4d-50e8-55d7-e053-2991aa0ad0763

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59883-030-04598830030041 TUBE in 1 BOX (59883-030-04) / 112 g in 1 TUBE1 tube2017-01-060000-00-00NoNoCurrent