Benzodent

Benzodent is an FDA-registered drug product whose active ingredient is BENZOCAINE. It is labelled by Focus Consumer Healthcare, LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 71687-1053, application M017, label effective 20260420. It is one of 70 FDA drug label records sharing the active ingredient BENZOCAINE. 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 are most often described in connection with: temporary relief, pain due, minor irritation, gums caused, dentures orthodontic, appliances injury. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

For the temporary relief of pain due to minor irritation of the mouth and gums caused by dentures or orthodontic appliances or injury to mouth and gums.

Adults and children 12 years and over: remove cap, break metal seal with cap point apply directly to the gums or to the denture surface that comes in contact with the affected area of the gums if you are using the dentures, wait a few minutes then reinsert dentures and you may use your regular denture adhesive with this product use up to 4 times daily or as directed by a dentist or doctor children under 12 years of age should be supervised in the use of this product children under 12 years: consult a dentist or doctor

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 to the blood. This can occur even if you have used this product before. Stop use and seek immedicate 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 Alllergy alert: Do not use if you have a history of allergy to local anetsthetics such as procaine, butacaine, benzocaine, or other "caine: anesthetics. Localized allergic reactions may occur after prolonged or repeated use. Do not use for more than 7 consecutive days unless directed by a dentist of a doctor for teething in children under 2 years of age When using this product avoid contact with eyes do not exceed recommended dosage Stop use and ssk a doctor or dentist if sore mouth symptoms do not improve in 7 days swelling, rash or fever develops irritation, pain or redness persists or worsens Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

FDA lists 70 drug label records with BENZOCAINE 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.

What is Benzodent used for?
For the temporary relief of pain due to minor irritation of the mouth and gums caused by dentures or orthodontic appliances or injury to mouth and gums.

Who makes Benzodent?
Focus Consumer Healthcare, LLC is the labeler of record for Benzodent. 70 FDA label records share the active ingredient BENZOCAINE, 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 Benzodent 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 Benzodent 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?
Yes. 70 FDA drug label records list BENZOCAINE 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 Benzodent been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

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.