Home NDC 68400-136 Gelato Neutral pH
Product NDC 68400-136
11-digit product format 684000136
Labeler code 68400
Product ID 68400-136_16b24df6-2bec-a706-e063-6294a90a5fba
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 Ingredient Strength SODIUM FLUORIDE 4.086 g/454g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 245593 Internal RxNorm lookup 656838 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68400-136-15 Gelato Neutral pH 454 g in 1 BOTTLE, PLASTIC GEL 454 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SODIUM FLUORIDE ACTIVE INGREDIENT 8ZYQ1474W7 GELATO NEUTRAL PH (SODIUM FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC] 8 FLUORIDE ION ACTIVE MOIETY Q80VPU408O GELATO NEUTRAL PH (SODIUM FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC] 8 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP GELATO NEUTRAL PH (SODIUM FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC] 8 MAGNESIUM ALUMINUM SILICATE INACTIVE INGREDIENT 6M3P64V0NC GELATO NEUTRAL PH (SODIUM FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC] 8 PHOSPHORIC ACID INACTIVE INGREDIENT E4GA8884NN GELATO NEUTRAL PH (SODIUM FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC] 8 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH GELATO NEUTRAL PH (SODIUM FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC] 8 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T GELATO NEUTRAL PH (SODIUM FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC] 8 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY GELATO NEUTRAL PH (SODIUM FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC] 8 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU GELATO NEUTRAL PH (SODIUM FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC] 8 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP GELATO NEUTRAL PH (SODIUM FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC] 8 WATER INACTIVE INGREDIENT 059QF0KO0R GELATO NEUTRAL PH (SODIUM FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC] 8 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE GELATO NEUTRAL PH (SODIUM FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC] 8 XYLITOL INACTIVE INGREDIENT VCQ006KQ1E GELATO NEUTRAL PH (SODIUM FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC] 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68400-136 GELATO NEUTRAL PH (SODIUM FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC] 12 Current NDC, Legacy NDC, 1 package rows 20240426_2f8fe488-4a1b-451a-852b-4ddc2cf08347.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 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Gelato Neutral pH SODIUM FLUORIDE Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc 2f8fe488-4a1b-451a-852b-4ddc2cf08347 2024-04-22 Warnings Exact identifier ndc (product): 68400-136
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 68400-136-15 68400013615 454 g in 1 BOTTLE, PLASTIC (68400-136-15) 454 g 2018-04-01 0000-00-00 No No Current