FDA.reportPublic FDA data

DOCTRUST ONE S Tooth

Product NDC
76670-0016
11-digit product format
766700016
Labeler code
76670
Product ID
76670-0016_33826193-17cc-21f5-e063-6294a90a0fe6
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium fluoride, Dental type silica, Potassium nirate
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
DOCSMEDI Co., Ltd.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-04-01
Substance
POTASSIUM NITRATE; SILICON DIOXIDE; SODIUM FLUORIDE
Active strength
5; 18.5; .31 g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DOCTRUST ONE S Tooth
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE5 g/100g
SILICON DIOXIDE18.5 g/100g
SODIUM FLUORIDE.31 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRU45X2JN0Z, ETJ7Z6XBU4, 8ZYQ1474W7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76670-0016-1DOCTRUST ONE S Tooth100 g in 1 TUBEPASTE, DENTIFRICE1001
76670-0016-2DOCTRUST ONE S Tooth1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76670-0016DOCTRUST ONE S TOOTH (SODIUM FLUORIDE, DENTAL TYPE SILICA, POTASSIUM NIRATE) PASTE, DENTIFRICE [DOCSMEDI CO., LTD.]1Current NDC, 2 package rows20250426_3382776a-a10e-1823-e063-6394a90a6f91.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76670-0016-176670001601100 g in 1 TUBE100 gHistorical
76670-0016-2766700016021 TUBE in 1 CARTON (76670-0016-2) / 100 g in 1 TUBE (76670-0016-1) 1 tube2025-04-01NoNoHistorical