Gelato Neutral pH

Product NDC
68400-324
11-digit product format
684000324
Labeler code
68400
Product ID
68400-324_16b249a0-bd35-a6a3-e063-6294a90a0f9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
GEL
Route
DENTAL
Labeler
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2013-03-01
Substance
SODIUM FLUORIDE
Active strength
4.086 g/454g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE4.086 g/454g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui245593, 656838

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68400-324-15Gelato Neutral pH454 g in 1 BOTTLE, PLASTICGEL4544

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68400-324GELATO NEUTRAL PH (SODIUM FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC]4Current NDC, Legacy NDC, 1 package rows20240426_738c98a9-6549-4179-8758-fc026c61c372.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
656838Gelato 2 % (fluoride ion 1.23 % ) Dental GelPSN738c98a9-6549-4179-8758-fc026c61c3724
245593sodium fluoride 2 % Dental GelPSN738c98a9-6549-4179-8758-fc026c61c3724
656838sodium fluoride 0.02 MG/MG Oral Gel [Gelato sodium fluoride]SBD738c98a9-6549-4179-8758-fc026c61c3724
245593sodium fluoride 0.02 MG/MG Oral GelSCD738c98a9-6549-4179-8758-fc026c61c3724
656838Gelato 0.02 MG/MG Oral GelSY738c98a9-6549-4179-8758-fc026c61c3724
656838Gelato APF (sodium fluoride 2 % (fluoride ion 1.23 % )) Dental GelSY738c98a9-6549-4179-8758-fc026c61c3724
656838Gelato APF (sodium fluoride 2.09 % (fluoride ion 1.23 % )) Dental GelSY738c98a9-6549-4179-8758-fc026c61c3724
245593sodium fluoride 2 % (fluoride ion 1.23 % ) Dental GelSY738c98a9-6549-4179-8758-fc026c61c3724
245593sodium fluoride 2.09 % (fluoride ion 1.23 % ) Dental GelSY738c98a9-6549-4179-8758-fc026c61c3724

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68400-324-1568400032415454 g in 1 BOTTLE, PLASTIC (68400-324-15) 454 g2018-04-010000-00-00NoNoCurrent