The short version
Just 2 companies supply this market — thin enough that a single exit would be felt immediately.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Ionite H
Sodium Fluoride, Potassium Nitrate · SODIUM FLUORIDE 1.1 mg/100g; POTASSIUM NITRATE 5 mg/100g · Gel, Dentifrice · Dental · Dharma Research, Inc.
NDC 53045-0281-04 · 122 g in 1 TUBE · 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 potassium nitrate and sodium fluoride (other) in the next 90 days
price up 14% YoY · 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, Potassium Nitrate (Gel, Dentifrice)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Dharma Research, Inc. | SODIUM FLUORIDE 1.1 mg/100g; POTASSIUM NITRATE 5 mg/100g | Aug 26, 2026 | Sep 2, 2026 |
| Mkj Brands Llc | POTASSIUM NITRATE 5 g/100g; SODIUM FLUORIDE 24 mg/100g | Jul 15, 2026 | Sep 2, 2026 |
| Mkj Brands Llc | SODIUM MONOFLUOROPHOSPHATE .76 g/100g | Jul 15, 2026 | Sep 2, 2026 |
| Dharma Research, Inc. | SODIUM FLUORIDE 5 mg/100g; POTASSIUM NITRATE 1.1 mg/100g | Jul 22, 2026 | Aug 20, 2026 |
| Dharma Research, Inc. | POTASSIUM NITRATE 5 mg/100g; SODIUM FLUORIDE 1.1 mg/100g | Jul 15, 2026 | Jul 16, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Ionite H — NDC 53045-0281-04," retrieved September 3, 2026, https://drugdashboards.com/drug/53045028104.
Free to cite with attribution — see how the data is put together.