PreviDent

Product NDC
0126-0016
11-digit product format
001260016
Labeler code
0126
Product ID
0126-0016_f4c2f476-bdd5-49d1-80f7-361be61e47e5
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
2009-07-06
Substance
SODIUM FLUORIDE
Active strength
6.1 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
Brand name suffix
5000 Dry Mouth
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE6.1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0126-0016-61PreviDent 5000 Dry Mouth100 mL in 1 BOTTLEGEL, DENTIFRICE1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0126-0016-61ML - Milliliter0126-00166a1ff55d-412c-4784-8b0b-2c5512f701f212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium fluorideACTIVE INGREDIENT8ZYQ1474W7PREVIDENT 5000 DRY MOUTH (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]1
fluoride ionACTIVE MOIETYQ80VPU408OPREVIDENT 5000 DRY MOUTH (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0126-0016PREVIDENT 5000 DRY MOUTH (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 1 package rows20221130_d93ee76f-454b-40bf-9357-39a2ae3b6ccb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
630194PreviDent 5000 Plus 1.1 % ToothpastePSNd93ee76f-454b-40bf-9357-39a2ae3b6ccb5
392038sodium fluoride 1.1 % ToothpastePSNd93ee76f-454b-40bf-9357-39a2ae3b6ccb5
630194sodium fluoride 0.011 MG/MG Toothpaste [Prevident]SBDd93ee76f-454b-40bf-9357-39a2ae3b6ccb5
392038sodium fluoride 0.011 MG/MG ToothpasteSCDd93ee76f-454b-40bf-9357-39a2ae3b6ccb5
630194Prevident 0.011 MG/MG ToothpasteSYd93ee76f-454b-40bf-9357-39a2ae3b6ccb5
630194PreviDent 1.1 % ToothpasteSYd93ee76f-454b-40bf-9357-39a2ae3b6ccb5
630194PreviDent 5000 Booster 1.1 % Oral GelSYd93ee76f-454b-40bf-9357-39a2ae3b6ccb5
392038sodium fluoride 1.1 % (fluoride ion 0.5 % ) ToothpasteSYd93ee76f-454b-40bf-9357-39a2ae3b6ccb5
392038sodium fluoride 1.1 % Dental GelSYd93ee76f-454b-40bf-9357-39a2ae3b6ccb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0126-0016-6100126001661100 mL in 1 BOTTLE (0126-0016-61) 100 ml2009-07-060000-00-00NoNoCurrent