Drugplain

Orajel 3X Medicated For Toothache and Gum 200 mg/g

Benzocaine, Menthol, Zinc chloride · GEL · Church & Dwight Co., Inc.

No Recall History
Plain English

Orajel 3X Medicated For Toothache And Gum is a topical gel containing benzocaine, menthol, and zinc chloride used to temporarily relieve pain from toothaches and gum discomfort. You apply it directly to the affected area in your mouth for numbing and pain relief.

Key Facts

Brand Name
Orajel 3X Medicated For Toothache and Gum
Generic Name
Benzocaine, Menthol, Zinc chloride
NDC Code (Product)
10237-790
Manufacturer
Church & Dwight Co., Inc.
Strength
200 mg/g
Dosage Form
GEL
Route
TOPICAL
Marketing Status
Application #
M022
Drug Class
Standardized Chemical Allergen [EPC]
Marketing Start
11/01/2019

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

asthenia3 reports
dizziness3 reports
fatigue2 reports
accidental exposure to product1 reports
atrial fibrillation1 reports
brain fog1 reports
drug effect less than expected1 reports
dry mouth1 reports
dyspnoea1 reports
feeling abnormal1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use for the temporary relief of pain due to minor irritation or injury of the mouth and gums

Dosage & Administration

Directions Adults and children 2 years of age and over Apply to affected area up to 4 times daily or as directed by a dentist or doctor Children between 2 and 12 years of age Ask a doctor before use. Should be supervised in the use of this product Children under 2 years of age Do not use

Warnings

Methemoglobinemia warning : use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: pale, gray, or blue colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, fatigue or lack of energy Allergy alert : do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics

Frequently Asked Questions

What is Orajel 3X Medicated For Toothache and Gum used for?

Orajel 3X Medicated For Toothache And Gum is a topical gel containing benzocaine, menthol, and zinc chloride used to temporarily relieve pain from toothaches and gum discomfort. You apply it directly to the affected area in your mouth for numbing and pain relief.

Is Orajel 3X Medicated For Toothache and Gum a controlled substance?

Orajel 3X Medicated For Toothache and Gum is not classified as a controlled substance by the DEA.

What is the generic name for Orajel 3X Medicated For Toothache and Gum?

The generic name for Orajel 3X Medicated For Toothache and Gum is Benzocaine, Menthol, Zinc chloride. There are 4 other brand versions of Benzocaine, Menthol, Zinc chloride.

What is the NDC code for Orajel 3X Medicated For Toothache and Gum 200 mg/g?

The NDC (National Drug Code) for Orajel 3X Medicated For Toothache and Gum 200 mg/g is 10237-790, listed by Church & Dwight Co., Inc..

Product NDC

10237-790

Package NDC

10237-790-12

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)