SORE THROAT

SORE THROAT is an FDA-registered drug product whose active ingredient is PHENOL. It is labelled by Raritan Pharmaceuticals Inc taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 68163-703, application M022, label effective 20260908. It is one of 9 FDA drug label records sharing the active ingredient PHENOL. 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 PHENOL are most often described in connection with: temporary relief, occasional minor, irritation pain, sore mouth. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Use(s) for the temporary relief of occasional minor irritation, pain, sore mouth and sore throat.

Directions ▪ Adults and children 12 years of age and older: Apply to the affected area (one spray). Allow to remain in place for at least 15 seconds, and then spit out. ▪ Use every 2 hours or as directed by a doctor or dentist. ▪ Children 6 years to under 12 years of age: should be supervised in the use of this product. ▪ Children under 6 years : Consult a doctor or dentist.

Warnings Sore Throat Warning: Severe or persistent sore throat or sore throat that accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or give to children under 6 years of age unless directed by doctor.

FDA lists 9 drug label records with PHENOL 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.

5 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 SORE THROAT used for?
Use(s) for the temporary relief of occasional minor irritation, pain, sore mouth and sore throat.

Who makes SORE THROAT?
Raritan Pharmaceuticals Inc is the labeler of record for SORE THROAT. 9 FDA label records share the active ingredient PHENOL, 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 SORE THROAT come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is SORE THROAT 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 PHENOL?
Yes. 9 FDA drug label records list PHENOL 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 SORE THROAT been recalled?
5 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.