KOLORZ SIXTY SECOND FLUORIDE FOAM

Product NDC
25047-763
11-digit product format
250470763
Labeler code
25047
Product ID
25047-763_abc23b24-2fa2-410c-b452-e57a3bca7af2
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
1.23 g/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 SIXTY SECOND FLUORIDE FOAM
Brand name suffix
COTTON CANDY
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.23 g/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
248389Internal RxNorm lookup
1093170Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
427f25e6-e50a-407a-a6f0-512123e381e4Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
25047-763-442021-10-04C16284748780-1ba0f9c33-1045-a910-e053-dadaa90a0b85kolorz ® Sixty Second Fluoride Foam
25047-763-442021-01-29C16284748780-1ba0f9c33-1045-a910-e053-dadaa90a0b85kolorz ® Sixty Second Fluoride Foam

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25047-763-44KOLORZ SIXTY SECOND FLUORIDE FOAM COTTON CANDY125 g in 1 CANAEROSOL, FOAM1253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25047-763KOLORZ SIXTY SECOND FLUORIDE FOAM BLUE RASPBERRY (SODIUM FLUORIDE) AEROSOL, FOAM KOLORZ SIXTY SECOND FLUORIDE FOAM CHERRY CHEESECAKE (SODIUM FLUORIDE) AEROSOL, FOAM KOLORZ SIXTY SECOND FLUORIDE FOAM COTTON CANDY (SODIUM FLUORIDE) AEROSOL, FOAM KOLORZ SIXTY SECOND FLUORIDE FOAM TRIPLE MINT (SODIUM FLUORIDE) AEROSOL, FOAM [DMG AMERICA, LLC]3Current NDC, Legacy NDC, 1 package rows20230819_427f25e6-e50a-407a-a6f0-512123e381e4.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
KOLORZ SIXTY SECOND FLUORIDE FOAM TRIPLE MINTSODIUM FLUORIDEDMG AMERICA, LLC427f25e6-e50a-407a-a6f0-512123e381e42021-10-01WarningsExact identifier
ndc (product): 25047-763

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1093170kolorz Sixty Second 2.72 % Oral FoamPSN427f25e6-e50a-407a-a6f0-512123e381e43
248389sodium fluoride 2.72 % Oral FoamPSN427f25e6-e50a-407a-a6f0-512123e381e43
1093170sodium fluoride 27.2 MG/ML Oral Foam [Kolorz]SBD427f25e6-e50a-407a-a6f0-512123e381e43
248389sodium fluoride 27.2 MG/ML Oral FoamSCD427f25e6-e50a-407a-a6f0-512123e381e43
1093170Kolorz 2.72 % Oral FoamSY427f25e6-e50a-407a-a6f0-512123e381e43
1093170Kolorz 27.2 MG/ML Oral FoamSY427f25e6-e50a-407a-a6f0-512123e381e43
248389sodium fluoride 2.72 % (fluoride ion 1.23 % ) Oral FoamSY427f25e6-e50a-407a-a6f0-512123e381e43
248389sodium fluoride 2.72 % Oral FoamSY427f25e6-e50a-407a-a6f0-512123e381e43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25047-763-4425047076344125 g in 1 CAN (25047-763-44) 125 g2006-11-220000-00-00NoNoCurrent