FDA.reportPublic FDA data

FLUORIDEX

Product NDC
59883-031
11-digit product format
598830031
Labeler code
59883
Product ID
59883-031_2cf0556f-5090-c02c-e063-6394a90a4b40
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
2016-12-21
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
59883-031-04FLUORIDEX1 in 1 BOXPASTE, DENTIFRICE15
59883-031-04FLUORIDEX112 g in 1 TUBEPASTE, DENTIFRICE1125
59883-031-05FLUORIDEX24 g in 1 TUBEPASTE, DENTIFRICE245

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59883-031-04GM - Gram59883-03117c3cf8a-6ab2-46e3-8ada-10998a1c952212019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59883-031FLUORIDEX (SODIUM FLUORIDE) PASTE, DENTIFRICE [DENT-MAT HOLDINGS, LLC.]5Current NDC, Legacy NDC, 3 package rows20250131_601774d5-f4de-01bc-e053-2991aa0a7f4f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
847014Fluoridex Daily Defense Sensitivity 5 % / 1.1 % ToothpastePSN601774d5-f4de-01bc-e053-2991aa0a7f4f5
637365potassium nitrate 5 % / sodium fluoride 1.1 % ToothpastePSN601774d5-f4de-01bc-e053-2991aa0a7f4f5
847014potassium nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG Toothpaste [Fluoridex Daily Defense Sensitivity]SBD601774d5-f4de-01bc-e053-2991aa0a7f4f5
637365potassium nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG ToothpasteSCD601774d5-f4de-01bc-e053-2991aa0a7f4f5
847014Fluoridex Daily Defense Sensitivity (potassium nitrate 5 % / sodium fluoride 1.1 % ) ToothpasteSY601774d5-f4de-01bc-e053-2991aa0a7f4f5
847014Fluoridex Daily Defense Sensitivity ToothpasteSY601774d5-f4de-01bc-e053-2991aa0a7f4f5
637365K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG ToothpasteSY601774d5-f4de-01bc-e053-2991aa0a7f4f5
847014K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG Toothpaste [Fluoridex Daily Defense Sensitivity]SY601774d5-f4de-01bc-e053-2991aa0a7f4f5
637365Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG ToothpasteSY601774d5-f4de-01bc-e053-2991aa0a7f4f5
847014Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG Toothpaste [Fluoridex Daily Defense Sensitivity]SY601774d5-f4de-01bc-e053-2991aa0a7f4f5
637365potassium nitrate 5 % / sodium fluoride 1.1 % Gel ToothpasteSY601774d5-f4de-01bc-e053-2991aa0a7f4f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59883-031-04598830031041 TUBE in 1 BOX (59883-031-04) / 112 g in 1 TUBE1 tube2016-12-210000-00-00NoNoCurrent
59883-031-055988300310524 g in 1 TUBE (59883-031-05) 24 g2018-08-220000-00-00YesNoCurrent