FDA.reportPublic FDA data

PreviDent

Product NDC
0126-0286
11-digit product format
001260286
Labeler code
0126
Product ID
0126-0286_5aa1cb04-ad2b-4675-a4bc-f6d8b04513d9
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
2012-08-29
Substance
SODIUM FLUORIDE
Active strength
11 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
PreviDent
Brand name suffix
5000 Plus Fruitastic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE11 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui392038, 630194

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0126-0286-66PreviDent 5000 Plus Fruitastic1 in 1 CARTONPASTE, DENTIFRICE17
0126-0286-66PreviDent 5000 Plus Fruitastic51 g in 1 TUBEPASTE, DENTIFRICE517

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0126-0286-66GM - Gram0126-02868caa8467-dde9-42ad-bd69-367cfec3fe7a12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W7PREVIDENT 5000 PLUS SPEARMINT (SODIUM FLUORIDE) PASTE, DENTIFRICE PREVIDENT 5000 PLUS FRUITASTIC (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]1
Fluoride IonACTIVE MOIETYQ80VPU408OPREVIDENT 5000 PLUS SPEARMINT (SODIUM FLUORIDE) PASTE, DENTIFRICE PREVIDENT 5000 PLUS FRUITASTIC (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]1
D&C Red No. 33INACTIVE INGREDIENT9DBA0SBB0LPREVIDENT 5000 PLUS SPEARMINT (SODIUM FLUORIDE) PASTE, DENTIFRICE PREVIDENT 5000 PLUS FRUITASTIC (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]1
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDPREVIDENT 5000 PLUS SPEARMINT (SODIUM FLUORIDE) PASTE, DENTIFRICE PREVIDENT 5000 PLUS FRUITASTIC (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]1
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1APREVIDENT 5000 PLUS SPEARMINT (SODIUM FLUORIDE) PASTE, DENTIFRICE PREVIDENT 5000 PLUS FRUITASTIC (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]1
Potassium PyrophosphateINACTIVE INGREDIENTB9W4019H5GPREVIDENT 5000 PLUS SPEARMINT (SODIUM FLUORIDE) PASTE, DENTIFRICE PREVIDENT 5000 PLUS FRUITASTIC (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]1
Saccharin Sodium DihydrateINACTIVE INGREDIENTSB8ZUX40TYPREVIDENT 5000 PLUS SPEARMINT (SODIUM FLUORIDE) PASTE, DENTIFRICE PREVIDENT 5000 PLUS FRUITASTIC (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4PREVIDENT 5000 PLUS SPEARMINT (SODIUM FLUORIDE) PASTE, DENTIFRICE PREVIDENT 5000 PLUS FRUITASTIC (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]1
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EUPREVIDENT 5000 PLUS SPEARMINT (SODIUM FLUORIDE) PASTE, DENTIFRICE PREVIDENT 5000 PLUS FRUITASTIC (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]1
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JPREVIDENT 5000 PLUS SPEARMINT (SODIUM FLUORIDE) PASTE, DENTIFRICE PREVIDENT 5000 PLUS FRUITASTIC (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]1
SorbitolINACTIVE INGREDIENT506T60A25RPREVIDENT 5000 PLUS SPEARMINT (SODIUM FLUORIDE) PASTE, DENTIFRICE PREVIDENT 5000 PLUS FRUITASTIC (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPPREVIDENT 5000 PLUS SPEARMINT (SODIUM FLUORIDE) PASTE, DENTIFRICE PREVIDENT 5000 PLUS FRUITASTIC (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RPREVIDENT 5000 PLUS SPEARMINT (SODIUM FLUORIDE) PASTE, DENTIFRICE PREVIDENT 5000 PLUS FRUITASTIC (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]1
Xanthan GumINACTIVE INGREDIENTTTV12P4NEEPREVIDENT 5000 PLUS SPEARMINT (SODIUM FLUORIDE) PASTE, DENTIFRICE PREVIDENT 5000 PLUS FRUITASTIC (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0126-0286PREVIDENT 5000 PLUS SPEARMINT (SODIUM FLUORIDE) PASTE, DENTIFRICE PREVIDENT 5000 PLUS FRUITASTIC (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 2 package rows20230322_5ef93306-59dd-447b-a2ec-dd865e52c76b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
630194PreviDent 5000 Plus 1.1 % ToothpastePSN5ef93306-59dd-447b-a2ec-dd865e52c76b7
392038sodium fluoride 1.1 % ToothpastePSN5ef93306-59dd-447b-a2ec-dd865e52c76b7
630194sodium fluoride 0.011 MG/MG Toothpaste [Prevident]SBD5ef93306-59dd-447b-a2ec-dd865e52c76b7
392038sodium fluoride 0.011 MG/MG ToothpasteSCD5ef93306-59dd-447b-a2ec-dd865e52c76b7
630194Prevident 0.011 MG/MG ToothpasteSY5ef93306-59dd-447b-a2ec-dd865e52c76b7
630194PreviDent 1.1 % ToothpasteSY5ef93306-59dd-447b-a2ec-dd865e52c76b7
630194PreviDent 5000 Booster 1.1 % Oral GelSY5ef93306-59dd-447b-a2ec-dd865e52c76b7
392038sodium fluoride 1.1 % (fluoride ion 0.5 % ) ToothpasteSY5ef93306-59dd-447b-a2ec-dd865e52c76b7
392038sodium fluoride 1.1 % Dental GelSY5ef93306-59dd-447b-a2ec-dd865e52c76b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0126-0286-66001260286661 TUBE in 1 CARTON (0126-0286-66) / 51 g in 1 TUBE1 tube2012-08-290000-00-00NoNoCurrent