Gelato Homecare

Product NDC
68400-205
11-digit product format
684000205
Labeler code
68400
Product ID
68400-205_16b18ba2-a212-830c-e063-6394a90a7e0f
Type
HUMAN OTC DRUG
Nonproprietary name
Stannous Fluoride
Dosage form
GEL
Route
DENTAL
Labeler
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-01-05
Substance
STANNOUS FLUORIDE
Active strength
.116 g/120g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gelato Homecare
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STANNOUS FLUORIDE.116 g/120g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3FTR44B32Q
Rxcui237847

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68400-205-04Gelato Homecare120 g in 1 TUBEGEL1208

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68400-205GELATO HOMECARE (STANNOUS FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]8Current NDC, Legacy NDC, 1 package rows20240426_07d7fb43-8d3e-4d1f-b38d-e3caf28e9acf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
237847stannous fluoride 0.4 % Oral GelPSN07d7fb43-8d3e-4d1f-b38d-e3caf28e9acf8
237847stannous fluoride 0.004 MG/MG Oral GelSCD07d7fb43-8d3e-4d1f-b38d-e3caf28e9acf8
237847stannous fluoride 0.4 % (fluoride ion 0.16 % ) Oral GelSY07d7fb43-8d3e-4d1f-b38d-e3caf28e9acf8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68400-205-0468400020504120 g in 1 TUBE (68400-205-04) 120 g2016-09-010000-00-00NoNoCurrent