Orajel Medicated for Toothache and Gum, Liquid

Orajel Medicated for Toothache and Gum, Liquid is an FDA-registered drug product whose active ingredient is BENZOCAINE AND MENTHOL. It is labelled by Church & Dwight Co., Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 10237-796, application M022, label effective 20260601. It is one of 5 FDA drug label records sharing the active ingredient BENZOCAINE AND MENTHOL. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing BENZOCAINE AND MENTHOL are most often described in connection with: temporary relief, pain due, canker sores, minor injury, gums caused, dentures orthodontic. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses Uses for the temporary relief of pain due to • canker sores • minor injury of the mouth and gums • minor irritation of the mouth and gums caused by dentures or orthodontic appliances

Directions • remove safety seal from bottle cap adults and children 2 years of age and over Apply product with applicator brush to the affected area. Use up to 4 times daily or as directed by a dentist or doctor. children between 2 and 12 years of age 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 the 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 or 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 Flammable : keep away from fire or flame. Avoid smoking during application. Do not use • more than directed • for more than 7 days unless directed by a dentist or doctor • for teething • in children under 2 years of age Stop use and ask a doctor if • swelling, rash or fever develops • irritation, pain or redness persists or worsens • sore mouth symptoms do not improve in 7 days Keep out of reach of children. If more than is used for pain relief is accidentally swallowed, get medical help or contact a Poison Control Center right away.

FDA lists 5 drug label records with BENZOCAINE AND MENTHOL as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

2 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Orajel Medicated for Toothache and Gum, Liquid used for?
Uses Uses for the temporary relief of pain due to • canker sores • minor injury of the mouth and gums • minor irritation of the mouth and gums caused by dentures or orthodontic appliances

Who makes Orajel Medicated for Toothache and Gum, Liquid?
Church & Dwight Co., Inc. is the labeler of record for Orajel Medicated for Toothache and Gum, Liquid. 5 FDA label records share the active ingredient BENZOCAINE AND MENTHOL, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Orajel Medicated for Toothache and Gum, Liquid come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Orajel Medicated for Toothache and Gum, Liquid prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing BENZOCAINE AND MENTHOL?
Yes. 5 FDA drug label records list BENZOCAINE AND MENTHOL as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Orajel Medicated for Toothache and Gum, Liquid been recalled?
2 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.