PreviDent

Product NDC
0126-0287
11-digit product format
001260287
Labeler code
0126
Product ID
0126-0287_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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0126-0287DDiscontinued by firm2026-08-11
excluded packagepackage0126-02870126-0287-33DDiscontinued by firm2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0126-0287-33d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0126-0287-33f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0126-0287-332ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0126-0287-33a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0126-0287-33cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0126-0287-33cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0126-0287-33302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0126-0287-33ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0126-0287-330efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0126-0287-33ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0126-0287-33367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0126-0287-33557ba5c1ecfa…9c80585c8c6e…

Additional Listing Data#

Finished product
Yes
Brand name base
PreviDent
Brand name suffix
5000 Plus Spearmint
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE11 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
392038Internal RxNorm lookup
630194Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5ef93306-59dd-447b-a2ec-dd865e52c76bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0126-0287-66PreviDent 5000 Plus Spearmint1 in 1 CARTONPASTE, DENTIFRICE17
0126-0287-66PreviDent 5000 Plus Spearmint51 g in 1 TUBEPASTE, DENTIFRICE517

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0126-0287-33GM - Gram0126-0287046bd473-5af0-428d-a29d-9fa58ff61ae712013-02-13
0126-0287-66GM - Gram0126-028755103c99-3112-4b9f-af7b-923203dd77a512013-02-13

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
0126-0287PREVIDENT 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

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 Plus FruitasticSODIUM FLUORIDEColgate Oral Pharmaceuticals Inc.5ef93306-59dd-447b-a2ec-dd865e52c76b2026-06-18Warnings, Adverse reactionsExact identifier
ndc (product): 0126-0287

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
0126-0287-66001260287661 TUBE in 1 CARTON (0126-0287-66) / 51 g in 1 TUBE1 tube2012-08-290000-00-00NoNoCurrent