PreviDent Very Berry

Product NDC
0126-0288
11-digit product format
001260288
Labeler code
0126
Product ID
0126-0288_e16a75ef-1e92-474e-8134-f9f3416a07ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
Colgate Oral Pharmaceuticals, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2012-08-29
Substance
SODIUM FLUORIDE
Active strength
5 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 Very Berry
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE5 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
2ecc57ec-cd25-4911-9247-6375569b8abeAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0126-0288-02PreviDent Very Berry1 in 1 CARTONGEL, DENTIFRICE18
0126-0288-02PreviDent Very Berry56 g in 1 TUBEGEL, DENTIFRICE568

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0126-0288-02GM - Gram0126-02889ebd5922-30c4-4937-bd42-443089cba9c912013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W7PREVIDENT (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]1
Fluoride IonACTIVE MOIETYQ80VPU408OPREVIDENT (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]1
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDPREVIDENT (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]1
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOAPREVIDENT (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]1
Hydroxyethyl Cellulose (5000 MPA.S AT 1%)INACTIVE INGREDIENTX70SE62ZARPREVIDENT (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TPREVIDENT (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]1
Poloxamer 407INACTIVE INGREDIENTTUF2IVW3M2PREVIDENT (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]1
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHPREVIDENT (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]1
Saccharin Sodium DihydrateINACTIVE INGREDIENTSB8ZUX40TYPREVIDENT (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]1
SorbitolINACTIVE INGREDIENT506T60A25RPREVIDENT (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPPREVIDENT (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RPREVIDENT (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0126-0288PREVIDENT FRESH MINT (SODIUM FLUORIDE) GEL, DENTIFRICE PREVIDENT VERY BERRY (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 2 package rows20230322_2ecc57ec-cd25-4911-9247-6375569b8abe.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 Fresh MintSODIUM FLUORIDEColgate Oral Pharmaceuticals, Inc.2ecc57ec-cd25-4911-9247-6375569b8abe2023-03-17Warnings, Adverse reactionsExact identifier
ndc (product): 0126-0288

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
630194PreviDent 5000 Plus 1.1 % ToothpastePSN2ecc57ec-cd25-4911-9247-6375569b8abe8
392038sodium fluoride 1.1 % ToothpastePSN2ecc57ec-cd25-4911-9247-6375569b8abe8
630194sodium fluoride 0.011 MG/MG Toothpaste [Prevident]SBD2ecc57ec-cd25-4911-9247-6375569b8abe8
392038sodium fluoride 0.011 MG/MG ToothpasteSCD2ecc57ec-cd25-4911-9247-6375569b8abe8
630194Prevident 0.011 MG/MG ToothpasteSY2ecc57ec-cd25-4911-9247-6375569b8abe8
630194PreviDent 1.1 % ToothpasteSY2ecc57ec-cd25-4911-9247-6375569b8abe8
630194PreviDent 5000 Booster 1.1 % Oral GelSY2ecc57ec-cd25-4911-9247-6375569b8abe8
392038sodium fluoride 1.1 % (fluoride ion 0.5 % ) ToothpasteSY2ecc57ec-cd25-4911-9247-6375569b8abe8
392038sodium fluoride 1.1 % Dental GelSY2ecc57ec-cd25-4911-9247-6375569b8abe8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0126-0288-02001260288021 TUBE in 1 CARTON (0126-0288-02) / 56 g in 1 TUBE1 tube2016-07-150000-00-00NoNoCurrent