Home NDC 0126-0165 Gel-Kam Fruit and Berry
Product NDC 0126-0165
11-digit product format 001260165
Labeler code 0126
Product ID 0126-0165_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 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Gel-Kam Fruit and Berry
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength STANNOUS FLUORIDE 1 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3FTR44B32Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 237847 Internal RxNorm lookup 750088 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0126-0165-93 Gel-Kam Fruit and Berry 122 g in 1 TUBE GEL, DENTIFRICE 122 13 0126-0165-93 Gel-Kam Fruit and Berry 1 in 1 CARTON GEL, DENTIFRICE 1 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Stannous Fluoride ACTIVE INGREDIENT 3FTR44B32Q GEL-KAM MINT (STANNOUS FLUORIDE) GEL, DENTIFRICE GEL-KAM FRUIT AND BERRY (STANNOUS FLUORIDE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.] 1 FLUORIDE ION ACTIVE MOIETY Q80VPU408O GEL-KAM MINT (STANNOUS FLUORIDE) GEL, DENTIFRICE GEL-KAM FRUIT AND BERRY (STANNOUS FLUORIDE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.] 1 Glycerin INACTIVE INGREDIENT PDC6A3C0OX GEL-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 INGREDIENT S38J6RZN16 GEL-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 NDC Dashboard title SPL version Validation Dashboard ZIP 0126-0165 GEL-KAM MINT (STANNOUS FLUORIDE) GEL, DENTIFRICE GEL-KAM FRUIT AND BERRY (STANNOUS FLUORIDE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.] 13 Current NDC, Legacy NDC, 2 package rows 20240119_8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c.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 40 of 50 · 995 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0126-0165-93 00126016593 1 TUBE in 1 CARTON (0126-0165-93) / 122 g in 1 TUBE 1 tube 1990-01-01 0000-00-00 No No Current