Home NDC 68400-109 Gelato APF
Product NDC 68400-109
11-digit product format 684000109
Labeler code 68400
Product ID 68400-109_d5f64c1b-8495-1049-e053-2995a90a7d33
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 2012-12-14
Substance SODIUM FLUORIDE
Active strength 5.6 g/454g
NDC exclude flag No
Listing certified through 2026-12-31
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 Gelato APF
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 5.6 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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68400-109-15 Gelato APF 454 g in 1 BOTTLE, PLASTIC GEL 454 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SODIUM FLUORIDE ACTIVE INGREDIENT 8ZYQ1474W7 GELATO APF (SODIUM FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.] 3 FLUORIDE ION ACTIVE MOIETY Q80VPU408O GELATO APF (SODIUM FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.] 3 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP GELATO APF (SODIUM FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.] 3 Magnesium Aluminum Silicate INACTIVE INGREDIENT 6M3P64V0NC GELATO APF (SODIUM FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.] 3 Phosphoric Acid INACTIVE INGREDIENT E4GA8884NN GELATO APF (SODIUM FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.] 3 Polysorbate 20 INACTIVE INGREDIENT 7T1F30V5YH GELATO APF (SODIUM FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.] 3 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY GELATO APF (SODIUM FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.] 3 Sodium Benzoate INACTIVE INGREDIENT OJ245FE5EU GELATO APF (SODIUM FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP GELATO APF (SODIUM FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.] 3 Water INACTIVE INGREDIENT 059QF0KO0R GELATO APF (SODIUM FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.] 3 Xanthan Gum INACTIVE INGREDIENT TTV12P4NEE GELATO APF (SODIUM FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.] 3 Xylitol INACTIVE INGREDIENT VCQ006KQ1E GELATO APF (SODIUM FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68400-109 GELATO APF (SODIUM FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.] 6 Current NDC, Legacy NDC, 1 package rows 20220120_b1d799c6-e483-44fd-b07c-94ca2ee239ef.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 APF SODIUM FLUORIDE Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. b1d799c6-e483-44fd-b07c-94ca2ee239ef 2022-01-19 Warnings Exact identifier ndc (product): 68400-109
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 68400-109-15 68400010915 454 g in 1 BOTTLE, PLASTIC (68400-109-15) 454 g 2016-06-01 0000-00-00 No No Current