Eugenol

Overview

Eugenol is a naturally occurring phenolic molecule found in several plants such as cinnamon, clove, and bay leaves. It has been used as a topical antiseptic as a counter-irritant and in dental preparations with zinc oxide for root canal sealing and pain control. Although not currently available in any FDA-approved products (including OTC), eugenol has been found to have anti-inflammatory, neuroprotective, antipyretic, antioxidant, antifungal and analgesic properties. Its exact mechanism of action is unknown, however, it has been shown to interfere with action potential conduction. There are a number of unapproved OTC products available containing eugenol that advertise its use for the treatment of toothache.

Indication

Eugenol is not currently available in any FDA-approved drug products. There are a number of unapproved OTC products that advertise it for the use of toothache. Eugenol is is also commonly used in combination with zinc oxide in dental procedures for the cementation of temporary prostheses and the temporary restoration of teeth and cavities.

Associated Conditions

Contusions
Insect Bites
Myalgia
Pruritis of the skin
Sprains
Oral discomfort and pain

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Comparative Single Blind Clinical Study on the Effect of Alvogyl, Eugenol, and Nigella Sativa (Black Seed Oil) for Alveolar Osteitis.	2025/02/12	NCT06823544	Phase 2	Not yet recruiting	HITEC-Institute of Medical Sciences
Periapical Healing in Response to Endodontically Treated Teeth With Different Sealing Cement	2024/07/01	NCT06482593	Phase 4	Active, not recruiting	Institucion Universitaria Colegios de Colombia
A Clinical Trial Comparing FS With ZOE and Non-eugenol Based Materials in Primary Teeth Pulpotomies	2022/09/28	NCT05557812	Early Phase 1	Completed	Virginia Commonwealth University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Dry Socket	Dentsply LLC, Professional Division, trading as "Sultan Healthcare"	0699-0404	DENTAL	0.0416 g in 1 g	1/26/2024

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
PT POWDER PT LIQUID 1 PT LIQUID 2	coralite dental products	00070262	Powder For Solution , Liquid - Dental	50 %	1/19/1993
TEMPRA CEMENT POWDER AND TEMPRA POLY LIQUID	Germiphene Corporation	00231827	Powder , Liquid - Dental	90 ML / 100 G	12/31/1971
EUGENOL	Germiphene Corporation	00274925	Liquid - Dental	100 %	12/31/1972
TRUE TEST	Smartpractice Denmark ApS	02271885	Patch - Topical	0.034 MG	3/16/2006
DRY SOCKET PASTE	sultan healthcare	00479225	Paste - Dental	4.16 %	12/31/1985
JIFFY TOOTHACHE DROPS	block drug company (canada) ltd.	00485772	Liquid - Dental	9 %	12/31/1979
ZONALIN LIQUID	associated dental products ltd.	02149710	Liquid - Dental	100 %	12/31/1970
ALVOGYL	Septodont	00555509	Paste - Dental	13.7 G / 100 G	12/31/1973

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
TRUTEST 36 APOSITO ADHESIVO PARA PRUEBA DE PROVOCACION CON ALERGENOS	Smartpractice Denmark Aps	85395	APÓSITO ADHESIVO PARA PRUEBA DE PROVOCACIÓN CON ALERGENOS	Medicamento Sujeto A Prescripción Médica	Commercialized
EPITEST 24 APOSITO ADHESIVO PARA PRUEBA DE PROVOCACION CON ALERGENOS	Smartpractice Denmark Aps	81160	APÓSITO ADHESIVO PARA PRUEBA DE PROVOCACIÓN CON ALERGENOS	Medicamento Sujeto A Prescripción Médica	Not Commercialized

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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