FDA.reportPublic FDA data

Gelato Perio Maintenance Rinse

Product NDC
68400-202
11-digit product format
684000202
Labeler code
68400
Product ID
68400-202_d60949c4-3bc6-2cd9-e053-2a95a90af5d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Stannous Fluoride
Dosage form
CONCENTRATE
Route
DENTAL
Labeler
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2013-02-01
Marketing end
0000-00-00
Substance
STANNOUS FLUORIDE
Active strength
0 g/283.5g
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68400-202DDiscontinued by firm2026-09-14
excluded packagepackage68400-20268400-202-10DDiscontinued by firm2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct68400-202DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68400-20268400-202-10DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Stannous FluorideACTIVE INGREDIENT3FTR44B32QGELATO PERIO MAINTENANCE RINSE (STANNOUS FLUORIDE ) CONCENTRATE [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]2
Fluoride IonACTIVE MOIETYQ80VPU408OGELATO PERIO MAINTENANCE RINSE (STANNOUS FLUORIDE ) CONCENTRATE [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXGELATO PERIO MAINTENANCE RINSE (STANNOUS FLUORIDE ) CONCENTRATE [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGELATO PERIO MAINTENANCE RINSE (STANNOUS FLUORIDE ) CONCENTRATE [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHGELATO PERIO MAINTENANCE RINSE (STANNOUS FLUORIDE ) CONCENTRATE [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYGELATO PERIO MAINTENANCE RINSE (STANNOUS FLUORIDE ) CONCENTRATE [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68400-202GELATO PERIO MAINTENANCE RINSE (STANNOUS FLUORIDE) CONCENTRATE [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]6Legacy NDC20240426_d2f0df92-d52f-4c9c-99d0-3cd2a025e5e9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68400-202-1068400020210283.5 g in 1 BOTTLE, PLASTIC (68400-202-10) 283.5 g2017-01-010000-00-00NoNoCurrent