Home NDC 68400-324 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 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 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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68400-324-15 Gelato Neutral pH 454 g in 1 BOTTLE, PLASTIC GEL 454 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68400-324 GELATO NEUTRAL PH (SODIUM FLUORIDE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC] 4 Current NDC, Legacy NDC, 1 package rows 20240426_738c98a9-6549-4179-8758-fc026c61c372.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 738c98a9-6549-4179-8758-fc026c61c372 2024-04-22 Warnings Exact identifier ndc (product): 68400-324
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 68400-324-15 68400032415 454 g in 1 BOTTLE, PLASTIC (68400-324-15) 454 g 2018-04-01 0000-00-00 No No Current