Gelato Homecare

Product NDC
68400-201
11-digit product format
684000201
Labeler code
68400
Product ID
68400-201_1679a47c-dc75-72ca-e063-6294a90a39c0
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
68400-201-04Gelato Homecare120 g in 1 TUBEGEL1207

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68400-201GELATO HOMECARE (STANNOUS FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]7Current NDC, Legacy NDC, 1 package rows20240426_1e93d4f8-1eec-40f8-8a6d-86e96dfeb8db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
237847stannous fluoride 0.4 % Oral GelPSN1e93d4f8-1eec-40f8-8a6d-86e96dfeb8db7
237847stannous fluoride 0.004 MG/MG Oral GelSCD1e93d4f8-1eec-40f8-8a6d-86e96dfeb8db7
237847stannous fluoride 0.4 % (fluoride ion 0.16 % ) Oral GelSY1e93d4f8-1eec-40f8-8a6d-86e96dfeb8db7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68400-201-0468400020104120 g in 1 TUBE (68400-201-04) 120 g2016-09-010000-00-00NoNoCurrent