FDA.reportPublic FDA data

Gel-Kam Mint

Product NDC
0126-0192
11-digit product format
001260192
Labeler code
0126
Product ID
0126-0192_d11d1acf-71a3-433a-8845-31d9a40bdfbd
Type
HUMAN OTC DRUG
Nonproprietary name
Stannous Fluoride
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
Colgate Oral Pharmaceuticals, Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1990-01-01
Substance
STANNOUS FLUORIDE
Active strength
1 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
Gel-Kam Mint
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STANNOUS FLUORIDE1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3FTR44B32Q
Rxcui237847, 750088

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0126-0192-93Gel-Kam Mint122 g in 1 TUBEGEL, DENTIFRICE12213
0126-0192-93Gel-Kam Mint1 in 1 CARTONGEL, DENTIFRICE113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0126-0192-93GM - Gram0126-01922f391b90-6296-499e-97e3-27ef5272ce9512015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Stannous FluorideACTIVE INGREDIENT3FTR44B32QGEL-KAM MINT (STANNOUS FLUORIDE) GEL, DENTIFRICE GEL-KAM FRUIT AND BERRY (STANNOUS FLUORIDE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OGEL-KAM MINT (STANNOUS FLUORIDE) GEL, DENTIFRICE GEL-KAM FRUIT AND BERRY (STANNOUS FLUORIDE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXGEL-KAM MINT (STANNOUS FLUORIDE) GEL, DENTIFRICE GEL-KAM FRUIT AND BERRY (STANNOUS FLUORIDE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]1
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)INACTIVE INGREDIENTS38J6RZN16GEL-KAM MINT (STANNOUS FLUORIDE) GEL, DENTIFRICE GEL-KAM FRUIT AND BERRY (STANNOUS FLUORIDE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0126-0192GEL-KAM MINT (STANNOUS FLUORIDE) GEL, DENTIFRICE GEL-KAM FRUIT AND BERRY (STANNOUS FLUORIDE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]13Current NDC, Legacy NDC, 2 package rows20240119_8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
750088Gel-Kam 0.4 % Oral GelPSN8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c13
237847stannous fluoride 0.4 % Oral GelPSN8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c13
750088stannous fluoride 0.004 MG/MG Oral Gel [Gel-Kam]SBD8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c13
237847stannous fluoride 0.004 MG/MG Oral GelSCD8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c13
750088Gel-Kam 0.004 MG/MG Oral GelSY8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c13
750088Gel-Kam 0.4 % Oral GelSY8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c13
237847stannous fluoride 0.4 % (fluoride ion 0.16 % ) Oral GelSY8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0126-0192-93001260192931 TUBE in 1 CARTON (0126-0192-93) / 122 g in 1 TUBE1 tube1990-01-010000-00-00NoNoCurrent