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; SODIUM FLUORIDE; SILICON DIOXIDE
Active strength
.2; .22; 15 g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
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
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 FLUORIDE.22 g/100g
SILICON DIOXIDE15 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9E8X80D2L0Internal UNII lookup
8ZYQ1474W7Internal UNII lookup
ETJ7Z6XBU4Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2713755Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
487cf27a-d761-6353-e063-6394a90af029Available on FDA.report

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

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
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
ndc (product): 85601-100

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