FDA.reportPublic FDA data

KOLORZ SIXTY SECOND FLUORIDE

Product NDC
25047-771
11-digit product format
250470771
Labeler code
25047
Product ID
25047-771_f15de5cf-4f64-472b-bda4-87daed17c864
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
GEL
Route
DENTAL
Labeler
DMG AMERICA, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2006-11-22
Substance
SODIUM FLUORIDE
Active strength
12.3 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
KOLORZ SIXTY SECOND FLUORIDE
Brand name suffix
TRIPLE MINT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE12.3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui1535362, 2121950

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
25047-771-162021-09-30C16284748780-1ba0f9c33-39b1-a910-e053-dadaa90a0b85kolorz ® Sixty Second Fluoride Gel
25047-771-162021-01-29C16284748780-1ba0f9c33-39b1-a910-e053-dadaa90a0b85kolorz ® Sixty Second Fluoride Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25047-771-16KOLORZ SIXTY SECOND FLUORIDETRIPLE MINT480 mL in 1 BOTTLEGEL4804

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25047-771KOLORZ SIXTY SECOND FLUORIDE CHERRY CHEESECAKE (SODIUM FLUORIDE) GEL KOLORZ SIXTY SECOND FLUORIDE PINA COLADA (SODIUM FLUORIDE) GEL KOLORZ SIXTY SECOND FLUORIDE TRIPLE MINT (SODIUM FLUORIDE) GEL KOLORZ SIXTY SECOND FLUORIDE BLUE RASPBERRY (SODIUM FLUORIDE) GEL KOLORZ SIXTY SECOND FLUORIDE COTTON CANDY (SODIUM FLUORIDE) GEL [DMG AMERICA, LLC]4Current NDC, Legacy NDC, 1 package rows20241003_21fa26f2-0162-4044-aec0-d5360be3f3e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2121950Kolorz Sixty Second Fluoride 2.72 % Oral GelPSN21fa26f2-0162-4044-aec0-d5360be3f3e04
1535362sodium fluoride 2.72 % Oral GelPSN21fa26f2-0162-4044-aec0-d5360be3f3e04
2121950sodium fluoride 0.0272 MG/MG Oral Gel [Kolorz]SBD21fa26f2-0162-4044-aec0-d5360be3f3e04
1535362sodium fluoride 0.0272 MG/MG Oral GelSCD21fa26f2-0162-4044-aec0-d5360be3f3e04
2121950Kolorz 0.0272 MG/MG Oral GelSY21fa26f2-0162-4044-aec0-d5360be3f3e04
2121950Kolorz 2.72 % Oral GelSY21fa26f2-0162-4044-aec0-d5360be3f3e04
1535362sodium fluoride 2.72 % (fluoride ion 1.23 % ) Oral GelSY21fa26f2-0162-4044-aec0-d5360be3f3e04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25047-771-1625047077116480 mL in 1 BOTTLE (25047-771-16) 480 ml2006-11-220000-00-00NoNoCurrent