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Kids Oral Care Flavor Free

Kids Oral Care Flavor Free

Approved
Approval ID

33469d77-4013-413d-e063-6294a90acbb7

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Apr 21, 2025

Manufacturers
FDA

TOOTHFILM INC.

DUNS: 656036549

Products 1

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

Xylitol, Calcium Lactate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code82711-106
Product Classification
G
Generic Name
Xylitol, Calcium Lactate
Product Specifications
Route of AdministrationDENTAL
Effective DateApril 21, 2025
FDA Product Classification

INGREDIENTS (11)

SODIUM ANISATEInactive
Code: F9WFJ28MV9
Classification: IACT
SODIUM LEVULINATEInactive
Code: VK44E1MQU8
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
CALCIUM OXIDEInactive
Code: C7X2M0VVNH
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SILICAInactive
Code: ETJ7Z6XBU4
Classification: IACT
DICALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
XYLITOLActive
Quantity: 2 mg in 20 mg
Code: VCQ006KQ1E
Classification: ACTIB
TREHALOSEInactive
Code: B8WCK70T7I
Classification: IACT
CALCIUM LACTATEActive
Quantity: 0.02 mg in 20 mg
Code: 2URQ2N32W3
Classification: ACTIB

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Kids Oral Care Flavor Free - FDA Drug Approval Details