FDA.reportPublic FDA data

DENTI BUONGIORNO PLAQUE CARE TOOTH

Product NDC
85601-060
11-digit product format
856010060
Labeler code
85601
Product ID
85601-060_41155922-d7ad-0a7a-e063-6294a90afe48
Type
HUMAN OTC DRUG
Nonproprietary name
Silica, Sodium Fluoride, Tocopheryl Acetate, Tetrasodium Pyrophosphate
Dosage form
PASTE, DENTIFRICE
Route
ORAL
Labeler
ATOSAFE CO., Ltd
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-04-01
Substance
.ALPHA.-TOCOPHEROL ACETATE; SILICON DIOXIDE; SODIUM FLUORIDE; SODIUM PYROPHOSPHATE
Active strength
.2; 17; .22; .5 g/100g; 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
DENTI BUONGIORNO PLAQUE CARE TOOTH
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
.ALPHA.-TOCOPHEROL ACETATE.2 g/100g
SODIUM PYROPHOSPHATE.5 g/100g
SILICON DIOXIDE17 g/100g
SODIUM FLUORIDE.22 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9E8X80D2L0Internal UNII lookup
O352864B8ZInternal UNII lookup
ETJ7Z6XBU4Internal UNII lookup
8ZYQ1474W7Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
41155922-d7ac-0a7a-e063-6294a90afe48Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85601-060-01DENTI BUONGIORNO PLAQUE CARE TOOTH100 g in 1 TUBEPASTE, DENTIFRICE1001
85601-060-02DENTI BUONGIORNO PLAQUE CARE 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 PLAQUE CARE TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE, TETRASODIUM PYROPHOSPHATEATOSAFE CO., Ltd41155922-d7ac-0a7a-e063-6294a90afe482025-10-13WarningsExact identifier
ndc (product): 85601-060

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85601-060-0185601006001100 g in 1 TUBE100 gHistorical
85601-060-02856010060021 TUBE in 1 CARTON (85601-060-02) / 100 g in 1 TUBE (85601-060-01) 1 tube2025-04-01NoNoCurrent