PreviDent OrthoDefense

Product NDC
0126-0289
11-digit product format
001260289
Labeler code
0126
Product ID
0126-0289_7614b377-1c90-4bce-a8d7-f439ec93ceb8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Colgate Oral Pharmaceuticals, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2019-03-04
Substance
SODIUM FLUORIDE
Active strength
6 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 OrthoDefense
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE6 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0126-0289-92PreviDent OrthoDefense100 mL in 1 BOTTLEPASTE, DENTIFRICE1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0126-0289-92ML - Milliliter0126-028918ecfdf4-58ba-4250-a4c1-faab31da0b4b12020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0126-0289PREVIDENT ORTHODEFENSE (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 1 package rows20220715_99d37f3e-ac4f-4e8f-92e3-9b27d7632d35.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
630194PreviDent 5000 Plus 1.1 % ToothpastePSN99d37f3e-ac4f-4e8f-92e3-9b27d7632d354
392038sodium fluoride 1.1 % ToothpastePSN99d37f3e-ac4f-4e8f-92e3-9b27d7632d354
630194sodium fluoride 0.011 MG/MG Toothpaste [Prevident]SBD99d37f3e-ac4f-4e8f-92e3-9b27d7632d354
392038sodium fluoride 0.011 MG/MG ToothpasteSCD99d37f3e-ac4f-4e8f-92e3-9b27d7632d354
630194Prevident 0.011 MG/MG ToothpasteSY99d37f3e-ac4f-4e8f-92e3-9b27d7632d354
630194PreviDent 1.1 % ToothpasteSY99d37f3e-ac4f-4e8f-92e3-9b27d7632d354
630194PreviDent 5000 Booster 1.1 % Oral GelSY99d37f3e-ac4f-4e8f-92e3-9b27d7632d354
392038sodium fluoride 1.1 % (fluoride ion 0.5 % ) ToothpasteSY99d37f3e-ac4f-4e8f-92e3-9b27d7632d354
392038sodium fluoride 1.1 % Dental GelSY99d37f3e-ac4f-4e8f-92e3-9b27d7632d354

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0126-0289-9200126028992100 mL in 1 BOTTLE (0126-0289-92) 100 ml2019-03-070000-00-00NoNoCurrent