FDA.reportPublic FDA data

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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DENTI BUONGIORNO GUM CARE COOL MINT TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEATOSAFE CO., Ltd487cf27a-d761-6353-e063-6394a90af0292026-01-16WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings • Keep out of reach of children under 6 years of age. • If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

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
SODIUM FLUORIDE15 g/100g
SILICON DIOXIDE.22 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9E8X80D2L0, 8ZYQ1474W7, ETJ7Z6XBU4
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