TideFresh MOUTH SORE AND TOOTHACHE

TideFresh MOUTH SORE AND TOOTHACHE is an FDA-registered drug product whose active ingredient is BENZOCAINE 20% MOUTH SORE AND TOOTHACHE. It is labelled by Wenzhou Yuyuan Pharmaceutical Co., Ltd. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 87786-001, application M022, label effective 20260613. 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 20% MOUTH SORE AND TOOTHACHE are most often described in connection with: temporarily relieves, minor irritation, gums due, canker sores. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Use Temporarily relieves pain and minor irritation of the mouth and gums due to canker sores.

Directions Remove protective cap before use; prime pump by pressing several times prior to initial application. Spray directly onto affected oral ulcer/sore area to form a thin protective coating. Adult supervision required when product is used by children. Adults and children 2 years of age and older: apply up to 4 times daily or as directed by a doctor/dentist. 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

What is TideFresh MOUTH SORE AND TOOTHACHE used for?
Use Temporarily relieves pain and minor irritation of the mouth and gums due to canker sores.

Who makes TideFresh MOUTH SORE AND TOOTHACHE?
Wenzhou Yuyuan Pharmaceutical Co., Ltd. is the labeler of record for TideFresh MOUTH SORE AND TOOTHACHE.

What form does TideFresh MOUTH SORE AND TOOTHACHE 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 TideFresh MOUTH SORE AND TOOTHACHE 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.

Has TideFresh MOUTH SORE AND TOOTHACHE 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.