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DENTI BOUNGIORNO ORIGINAL TOOTH

Approved
Approval ID

3487b2db-5f78-625f-e063-6294a90a0c8c

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 7, 2025

Manufacturers
FDA

ATOSAFE CO., Ltd

DUNS: 688995680

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Silica, Sodium Monofluorophosphate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85601-010
Product Classification
G
Generic Name
Silica, Sodium Monofluorophosphate
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2025
FDA Product Classification

INGREDIENTS (6)

SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM COCOYL GLUTAMATEInactive
Code: BMT4RCZ3HG
Classification: IACT
SILICON DIOXIDEActive
Quantity: 18 g in 100 g
Code: ETJ7Z6XBU4
Classification: ACTIB
SODIUM MONOFLUOROPHOSPHATEActive
Quantity: 0.76 g in 100 g
Code: C810JCZ56Q
Classification: ACTIM

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DENTI BOUNGIORNO ORIGINAL TOOTH - FDA Drug Approval Details