MedPath

Xylitol

Generic Name
Xylitol
Drug Type
Small Molecule
Chemical Formula
C5H12O5
CAS Number
87-99-0
Unique Ingredient Identifier
VCQ006KQ1E

Overview

Xylitol is a naturally occurring five-carbon sugar alcohol found in most plant material, including many fruits and vegetables. Xylitol-rich plant materials include birch and beechwood . It is widely used as a sugar substitute and in "sugar-free" food products. The effects of xylitol on dental caries have been widely studied, and xylitol is added to some chewing gums and other oral care products to prevent tooth decay and dry mouth. Xylitol is a non-fermentable sugar alcohol by most plaque bacteria, indicating that it cannot be fermented into cariogenic acid end-products . It works by inhibiting the growth of the microorganisms present in plaque and saliva after it accummulates intracellularly into the microorganism . The recommended dose of xylitol for dental caries prevention is 6–10 g/day, and most adults can tolerate 40 g/day without adverse events .

Indication

Indicated for use as a sugar substitute, and oral hygiene active ingredient.

Associated Conditions

No associated conditions information available.

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
TOOTHFILM INC.
82711-106
DENTAL
2 mg in 20 mg
4/21/2025

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Xylitol for Injection
国药准字H20060302
化学药品
注射剂
11/9/2020
Xylitol for Injection
国药准字H20060147
化学药品
注射剂
9/5/2020
Xylitol Tablets
国药准字H11022384
化学药品
片剂
11/20/2020
Xylitol Tablets
国药准字H33021818
化学药品
片剂
8/23/2024
Xylitol Tablets
国药准字H33021819
化学药品
片剂
8/23/2024
Xylitol and Sodium Chloride Injection
国药准字H20041077
化学药品
注射剂
5/22/2020
Xylitol and Sodium Chloride Injection
国药准字H20041076
化学药品
注射剂
5/15/2020
Xylitol Granules
国药准字H33021847
化学药品
颗粒剂
4/29/2020
Xylitol Granules
国药准字H22024312
化学药品
颗粒剂
7/23/2020
Xylitol Granules
国药准字H22026532
化学药品
颗粒剂
5/6/2020

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

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