FDA.reportPublic FDA data

PreviDent

Product NDC
0126-0070
11-digit product format
001260070
Labeler code
0126
Product ID
0126-0070_9d1b6e76-002b-49e4-b483-be15723a03d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium fluoride and Potassium nitrate
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
Colgate Oral Pharmaceuticals, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2009-07-06
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
57.5; 5.8 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PreviDent
Brand name suffix
5000 Sensitive
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE57.5 mg/mL
SODIUM FLUORIDE5.8 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRU45X2JN0Z, 8ZYQ1474W7
Rxcui637365, 999717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0126-0070-61PreviDent 5000 Sensitive100 mL in 1 BOTTLEGEL, DENTIFRICE1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0126-0070-61ML - Milliliter0126-00705d961368-b38b-4ff1-8cd9-838d1377854812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Potassium nitrateACTIVE INGREDIENTRU45X2JN0ZPREVIDENT 5000 SENSITIVE (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]1
Sodium fluorideACTIVE INGREDIENT8ZYQ1474W7PREVIDENT 5000 SENSITIVE (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]1
fluoride ionACTIVE MOIETYQ80VPU408OPREVIDENT 5000 SENSITIVE (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]1
Potassium cationACTIVE MOIETY295O53K152PREVIDENT 5000 SENSITIVE (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0126-0070PREVIDENT 5000 SENSITIVE (SODIUM FLUORIDE AND POTASSIUM NITRATE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 1 package rows20220819_b028cfff-4946-49e8-b8bb-197ab99d0d35.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
637365potassium nitrate 5 % / sodium fluoride 1.1 % ToothpastePSNb028cfff-4946-49e8-b8bb-197ab99d0d357
999717PreviDent 5000, Colgate 5 % / 1.1 % ToothpastePSNb028cfff-4946-49e8-b8bb-197ab99d0d357
999717potassium nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG Toothpaste [Prevident 5000 Sensitive]SBDb028cfff-4946-49e8-b8bb-197ab99d0d357
637365potassium nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG ToothpasteSCDb028cfff-4946-49e8-b8bb-197ab99d0d357
999717Colgate Prevident 5000 Sensitive (potassium nitrate 5 % / sodium fluoride 1.1 % ) ToothpasteSYb028cfff-4946-49e8-b8bb-197ab99d0d357
637365K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG ToothpasteSYb028cfff-4946-49e8-b8bb-197ab99d0d357
999717K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG Toothpaste [Prevident 5000 Sensitive]SYb028cfff-4946-49e8-b8bb-197ab99d0d357
637365Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG ToothpasteSYb028cfff-4946-49e8-b8bb-197ab99d0d357
999717Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG Toothpaste [Prevident 5000 Sensitive]SYb028cfff-4946-49e8-b8bb-197ab99d0d357
637365potassium nitrate 5 % / sodium fluoride 1.1 % Gel ToothpasteSYb028cfff-4946-49e8-b8bb-197ab99d0d357
999717Prevident 5000 Enamel Protect (potassium nitrate 5 % / sodium fluoride 1.1 % ) ToothpasteSYb028cfff-4946-49e8-b8bb-197ab99d0d357

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0126-0070-6100126007061100 mL in 1 BOTTLE (0126-0070-61) 100 ml2009-07-060000-00-00NoNoCurrent