DENTI BUONGIORNO GUM CARE COOL MINT TOOTH

Product NDC
85601-100
11-digit product format
856010100
Labeler code
85601
Product ID
85601-100_487cf352-a14e-dd89-e063-6394a90a6053
Type
HUMAN OTC DRUG
Nonproprietary name
Silica, Sodium Fluoride, Tocopheryl Acetate
Dosage form
PASTE, DENTIFRICE
Route
ORAL
Labeler
ATOSAFE CO., Ltd
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2026-01-02
Substance
.ALPHA.-TOCOPHEROL ACETATE; SILICON DIOXIDE; SODIUM FLUORIDE
Active strength
.2; 15; .22 g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DENTI BUONGIORNO GUM CARE COOL MINT TOOTH
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
.ALPHA.-TOCOPHEROL ACETATE.2 g/100g
SILICON DIOXIDE15 g/100g
SODIUM FLUORIDE.22 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9E8X80D2L0, ETJ7Z6XBU4, 8ZYQ1474W7
Rxcui2713755

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85601-100-01DENTI BUONGIORNO GUM CARE COOL MINT TOOTH100 g in 1 TUBEPASTE, DENTIFRICE1001
85601-100-02DENTI BUONGIORNO GUM CARE COOL MINT TOOTH1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2713755alpha-tocopherol acetate 0.2 % / silicon dioxide 15 % / sodium fluoride 0.22 % ToothpastePSN487cf27a-d761-6353-e063-6394a90af0291
2713755alpha-tocopherol acetate 0.002 MG/MG / silicon dioxide 0.15 MG/MG / sodium fluoride 0.0022 MG/MG ToothpasteSCD487cf27a-d761-6353-e063-6394a90af0291
2713755alpha-tocopherol acetate 0.2 % / silicon dioxide 15 % / sodium fluoride 0.22 % ToothpasteSY487cf27a-d761-6353-e063-6394a90af0291

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85601-100-0185601010001100 g in 1 TUBE100 gHistorical
85601-100-02856010100021 TUBE in 1 CARTON (85601-100-02) / 100 g in 1 TUBE (85601-100-01) 1 tube2026-01-02NoNoCurrent