KOLORZ NEUTRAL FLUORIDE FOAM

Product NDC
25047-765
11-digit product format
250470765
Labeler code
25047
Product ID
25047-765_79be0b6b-34c3-4e14-9702-54e7d4f1104e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
AEROSOL, FOAM
Route
DENTAL
Labeler
DMG AMERICA, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2006-11-22
Substance
SODIUM FLUORIDE
Active strength
.9 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
KOLORZ NEUTRAL FLUORIDE FOAM
Brand name suffix
TRIPLE MINT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.9 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui688393, 688397

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
25047-765-442021-10-04C16284748780-1ba0f9c33-2f61-a910-e053-dadaa90a0b85kolorz ® NEUTRAL Fluoride Foam
25047-765-442021-01-29C16284748780-1ba0f9c33-2f61-a910-e053-dadaa90a0b85kolorz ® NEUTRAL Fluoride Foam

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25047-765-44KOLORZ NEUTRAL FLUORIDE FOAM TRIPLE MINT125 g in 1 CANAEROSOL, FOAM1253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25047-765KOLORZ NEUTRAL FLUORIDE FOAM TRIPLE MINT (SODIUM FLUORIDE) AEROSOL, FOAM [DMG AMERICA, LLC]3Current NDC, Legacy NDC, 1 package rows20230819_b83c62be-8e9d-4fa2-aa10-d34c88bf2387.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
688397Kolorz 2 % Oral FoamPSNb83c62be-8e9d-4fa2-aa10-d34c88bf23873
688393sodium fluoride 2 % Oral FoamPSNb83c62be-8e9d-4fa2-aa10-d34c88bf23873
688397sodium fluoride 20 MG/ML Oral Foam [Kolorz]SBDb83c62be-8e9d-4fa2-aa10-d34c88bf23873
688393sodium fluoride 20 MG/ML Oral FoamSCDb83c62be-8e9d-4fa2-aa10-d34c88bf23873
688397Kolorz 2 % Oral FoamSYb83c62be-8e9d-4fa2-aa10-d34c88bf23873
688397Kolorz 20 MG/ML Oral FoamSYb83c62be-8e9d-4fa2-aa10-d34c88bf23873
688393sodium fluoride 2 % Oral FoamSYb83c62be-8e9d-4fa2-aa10-d34c88bf23873

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25047-765-4425047076544125 g in 1 CAN (25047-765-44) 125 g2006-11-220000-00-00NoNoCurrent