FDA.reportPublic FDA data

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 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
688393Internal RxNorm lookup
688397Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b83c62be-8e9d-4fa2-aa10-d34c88bf2387Available on FDA.report

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

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 NEUTRAL FLUORIDE FOAM TRIPLE MINTSODIUM FLUORIDEDMG AMERICA, LLCb83c62be-8e9d-4fa2-aa10-d34c88bf23872021-10-01WarningsExact identifier
ndc (product): 25047-765

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