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
SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength
5.8; 57.5 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
SODIUM FLUORIDE5.8 mg/mL
POTASSIUM NITRATE57.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup
RU45X2JN0ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
637365Internal RxNorm lookup
999717Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b028cfff-4946-49e8-b8bb-197ab99d0d35Available on FDA.report

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#

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

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
PreviDent 5000 SensitiveSODIUM FLUORIDE AND POTASSIUM NITRATEColgate Oral Pharmaceuticals, Inc.b028cfff-4946-49e8-b8bb-197ab99d0d352019-12-09Warnings, Adverse reactionsExact identifier
ndc (product): 0126-0070

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