Toothache

Toothache is an FDA-registered drug product whose active ingredient is POLYHEXAMETHYLENE BIGUANIDE HYDROCHLORIDE. It is labelled by Guchutang Biotechnology (Longyan) Co., Ltd taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 87083-012, application M022, label effective 20260620. 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 POLYHEXAMETHYLENE BIGUANIDE HYDROCHLORIDE are most often described in connection with: pregnant breastfeeding, infant young. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

if you are pregnant, breastfeeding, an infant or young child, or if you have an allergy to any ingredientof this product.

Spray directlyon the mouth (toothache) for discomfort, 1-3 sprays each time, 2-3 times a day or as needed.

1. This product isnot food, medicine or medical device. Do nottake orally. Keep out 2. If local irritation or discomfort occurs while using this product, please consult a 3. This is a health care product and cannot replace medicines or medical devices for treating diseases.

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 Toothache used for?
if you are pregnant, breastfeeding, an infant or young child, or if you have an allergy to any ingredientof this product.

Who makes Toothache?
Guchutang Biotechnology (Longyan) Co., Ltd is the labeler of record for Toothache.

What form does 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 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 Toothache 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.