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
No NMPA approvals found for this drug.

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.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
XYLIFRESH 100 (PEPPERMINT) - GUM 827 MG
leaf canada inc.
02202719
Gum - Dental
827 MG / PIECE
12/31/1996
TRIDENT ADVANTAGE GUM
pfizer canada inc., consumer healthcare division
02241544
Gum - Dental
364 MG
3/27/2000
XYLIFRESH 100 (SPEARMINT) - GUM
leaf canada inc.
02202700
Gum - Dental
827 MG / PIECE
12/31/1996

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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