The short version
7 companies supply this market — a reasonable cushion if one runs into trouble.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Ionite APF Foam
Sodium Fluoride · SODIUM FLUORIDE 1.5498 g/126g · Aerosol, Foam · Dental; Oral; Topical · Dharma Research, Inc.
NDC 53045-0250-44 · 126 g in 1 BOTTLE · UNAPPROVED DRUG OTHER · View full market →
Medicare Part D
No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.
How Part D pricing works →NADAC price per unit
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
90-day shortage risk (model v2)
0.1%chance of a new FDA shortage posting for sodium fluoride (other) in the next 90 days
sole-source market
For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.
Backtested statistical model over the whole market, not this package alone. Model details →
Where it's made
- Dharma Research, Inc.United Statesmanufacture
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Regulatory
- Application
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- TE code
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- Approval date
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- Patents / exclusivity
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Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Sodium Fluoride (Aerosol, Foam)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Darby Dental Supply, LLC | SODIUM FLUORIDE 2.72 g/100g | Jul 15, 2026 | Sep 3, 2026 |
| Henry Schein | SODIUM FLUORIDE .0272 g/g | Jul 15, 2026 | Sep 3, 2026 |
| Ross Healthcare Inc. | SODIUM FLUORIDE .0272 g/g | Jul 15, 2026 | Sep 3, 2026 |
| Young Dental Manufacturing Co 1, LLC | SODIUM FLUORIDE 2.72 g/100g | Jul 15, 2026 | Sep 3, 2026 |
| Dharma Research, Inc. | SODIUM FLUORIDE 1.5498 g/126g | Jul 15, 2026 | Sep 2, 2026 |
| Dmg America, Llc | SODIUM FLUORIDE 1.23 mg/g | Jul 15, 2026 | Sep 2, 2026 |
| Dmg America, Llc | SODIUM FLUORIDE .9 mg/g | Jul 15, 2026 | Sep 2, 2026 |
| Dharma Research, inc. | SODIUM FLUORIDE 1.5498 g/126g | Jul 15, 2026 | Aug 31, 2026 |
| Dmg America, Llc | SODIUM FLUORIDE 1.23 g/g | Jul 15, 2026 | Aug 31, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Ionite APF Foam — NDC 53045-0250-44," retrieved September 3, 2026, https://drugdashboards.com/drug/53045025044.
Free to cite with attribution — see how the data is put together.