Ionite APF

Ionite APF is an FDA-registered drug product whose active ingredient is SODIUM FLUORIDE. It is labelled by Dharma Research, Inc. taken by dental and marketed as a human prescription drug product. Identifiers on file: NDC 53045-205, label effective 20210220. It is one of 263 FDA drug label records sharing the active ingredient SODIUM FLUORIDE. 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 SODIUM FLUORIDE are most often described in connection with: fluoride treatment, help prevent, dental decay, home unsupervised, usage stable, professional office, instruct patient, caries preventive. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

FDA lists 263 drug label records with SODIUM FLUORIDE 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 Ionite APF used for?
The FDA label on file for this product does not include a full indications section. Other FDA labels sharing the active ingredient SODIUM FLUORIDE describe it in connection with: fluoride treatment, help prevent, dental decay, home unsupervised, usage stable, professional office, instruct patient, caries preventive. Check the specific product label or ask a prescriber before use.

Who makes Ionite APF?
Dharma Research, Inc. is the labeler of record for Ionite APF. 263 FDA label records share the active ingredient SODIUM FLUORIDE, 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 Ionite APF come in?
administered by dental. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

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

Are there other products containing SODIUM FLUORIDE?
Yes. 263 FDA drug label records list SODIUM FLUORIDE 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 Ionite APF 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.