Eugenol Toothache Medication

Manufacturer
Team Technologies, Inc
Effective date
2021-12-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:45:58

Label at a glance#

ProductEugenol Toothache Medication
Active ingredientEUGENOL
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Eugenol 85%

OTC - PURPOSE SECTION

Purpose Toothache Relief Agent

INDICATIONS & USAGE SECTION

Uses For the temporary relief of throbbing, persistent toothache due to a cavity. Visit Dentist within 48 hours of use.

WARNINGS SECTION

Warnings

For external use only. Allergy alert: do not use if you are allergic to eugenol (clove oil).

OTC - WHEN USING SECTION

When using this product:

. use only in teeth with persistent throbbing pain . DO NOT SWALLOW to avoid irritation . avoid contact with eyes

OTC - DO NOT USE SECTION

Do not use. For more than 7 days . more than the recommended dose

OTC - STOP USE SECTION

Stop use and ask a dentist or doctor if. irritation persists . inflammation develops . fever and infection develop

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children 2 to 12 years of age and older: Rinse tooth with water to remove any food particles from the cavity. Moisten a cotton pellet with 1 or 2 drops of medication and using the tweezer, place in the cavity for approximately 1 minute. Avoid touching tissues other than the tooth cavity . Apply the dose not more than four times daily or as directed by a dentist or physician.

Children 2 to 12 years of age: should be supervised in the use of this product.

Children under 2 years of age: use only under the advice of a dentist or physician.

OTHER SAFETY INFORMATION

Other information. Do not purchase if package has been opened. . Store at 46 - 90 o F. . Cap tightly to avoid evaporation. . toothaches and open cavities indicate serious problems which need prompt attention by a dentist.

INACTIVE INGREDIENT SECTION

Inactive ingredient sesame oil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

kit package labelkit package label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
244327eugenol 85 % Dental SolutionPSN2
244327eugenol 850 MG/ML Topical SolutionSCD2
244327eugenol 85 % Dental SolutionSY2
244327eugenol 85 % Topical SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
EUGENOL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67659-415-21Eugenol Toothache Medication1 in 1 KITLIQUID12
67659-415-23Eugenol Toothache Medication3.7 mL in 1 VIAL, GLASSLIQUID3.72

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67659-415EUGENOL TOOTHACHE MEDICATION (EUGENOL) LIQUID [TEAM TECHNOLOGIES, INC]2Legacy NDC, 2 package rows20211229_3afd5a15-02ee-27d3-e054-00144ff88e88.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67659-41567659-415-23, 67659-415-21
60630-686

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
SESAME OILQX10HYY4QVIACT
EUGENOL3T8H1794QWACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d43835d4-30ed-1b0f-e053-2995a90aa3673afd5a15-02ee-27d3-e054-00144ff88e882021-12-28WarningsExact identifier
spl id: d43835d4-30ed-1b0f-e053-2995a90aa367
spl set id: 3afd5a15-02ee-27d3-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.