MedPath

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

NDC Product Code85601-010
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateMay 7, 2025
Generic NameSilica, Sodium Monofluorophosphate

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

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

DENTI BOUNGIORNO ORIGINAL TOOTH - FDA Drug Approval Details