The short version
5 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.
Sensitive Tooth Polish
Potassium Nitrate and Sodium Fluoride · SODIUM FLUORIDE .26244 g/108g; POTASSIUM NITRATE 5.4 g/108g · Paste, Dentifrice · Topical · Melaleuca, Inc.
NDC 54473-0302-04 · 108 g in 1 TUBE · OTC MONOGRAPH NOT FINAL · View full market →
Medicare Part D
Medicare Part D does not cover over-the-counter drugs — by law it pays only for products requiring a prescription.
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 →
Is this a "specialty" drug?
There's no legal definition — it meets 1 of 6 public criteria. Why that matters →
- Part D specialty tier
- Costs ≥ $950/fill
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program · Xywav and Xyrem
Regulatory
- Application
- part356
- TE code
- —
- Approval date
- —
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Potassium Nitrate and Sodium Fluoride (Paste, Dentifrice)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Health and Natural Beauty USA Corp | POTASSIUM NITRATE 50 mg/g; SODIUM FLUORIDE 7.6 mg/g | Jul 15, 2026 | Sep 2, 2026 |
| Melaleuca, Inc. | SODIUM FLUORIDE .26244 g/108g; POTASSIUM NITRATE 5.4 g/108g | Aug 26, 2026 | Sep 2, 2026 |
| New World Imports, Inc | SODIUM FLUORIDE 2.4 mg/g; POTASSIUM NITRATE 50 mg/g | Aug 26, 2026 | Sep 2, 2026 |
| Colgate-Palmolive Company | POTASSIUM NITRATE 50 mg/g; SODIUM FLUORIDE 1.1 mg/g | Jul 15, 2026 | Aug 31, 2026 |
| Melaleuca, Inc | POTASSIUM NITRATE .2272 g/93.5g; SODIUM FLUORIDE 4.675 g/93.5g | Jul 15, 2026 | Aug 31, 2026 |
| Melaleuca, Inc. | SODIUM FLUORIDE 5.4 g/108g; POTASSIUM NITRATE .26244 g/108g | Jul 22, 2026 | Aug 19, 2026 |
| New World Imports, Inc | SODIUM FLUORIDE 50 mg/g; POTASSIUM NITRATE 2.4 mg/g | Jul 22, 2026 | Aug 19, 2026 |
| Melaleuca, Inc. | POTASSIUM NITRATE 5.4 g/108g; SODIUM FLUORIDE .26244 g/108g | Jul 15, 2026 | Jul 15, 2026 |
| New World Imports, Inc | POTASSIUM NITRATE 50 mg/g; SODIUM FLUORIDE 2.4 mg/g | Jul 15, 2026 | Jul 15, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Sensitive Tooth Polish — NDC 54473-0302-04," retrieved September 3, 2026, https://drugdashboards.com/drug/54473030204.
Free to cite with attribution — see how the data is put together.