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Sodium Fluoride 5000 ppm Enamel Protect

Sodium Fluoride1.1%, Potassium Nitrate 5% · POTASSIUM NITRATE 57.5 mg/mL; SODIUM FLUORIDE 5.8 mg/mL · Gel, Dentifrice · Dental · Sheffield Pharmaceuticals LLC

NDC 11527-0745-34 · 1 TUBE in 1 CARTON / 100 mL in 1 TUBE · UNAPPROVED DRUG OTHER · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles. The price is up 14% over the past year, to $0.1176 per mL. Put together: worth watching — several of the pressures that precede supply trouble are present at once.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

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

$0$0.05$0.1$0.15Sep 2021Sep 2026$0.1176
60 price points · per MLSource: CMS NADAC

Medicaid spend (2025)

$108,853
7,210 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

30Elevated risk

The score is counting real pressure here. One of these alone is routine; it’s the combination that makes this market worth watching.

  • 1 active manufacturer+30

The score counts pressure that is already visible — fewer makers, shortages, recalls, falling prices. 0 means none of it; 100 means all of it at once. Recomputed daily · as of Sep 3, 2026

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

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

Regulatory

Application
TE code
Approval date
Patents / exclusivity

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 Fluoride1.1%, Potassium Nitrate 5% (Gel, Dentifrice)

LabelerStrengthFirst seenLast seen
Sheffield Pharmaceuticals LLCPOTASSIUM NITRATE 57.5 mg/mL; SODIUM FLUORIDE 5.8 mg/mLJul 15, 2026Sep 2, 2026
Sheffield Pharmaceuticals LLCSODIUM FLUORIDE 5.8 mg/mL; POTASSIUM NITRATE 57.5 mg/mLAug 26, 2026Sep 2, 2026
Sheffield Pharmaceuticals LLCSODIUM FLUORIDE 57.5 mg/mL; POTASSIUM NITRATE 5.8 mg/mLJul 22, 2026Aug 19, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Sodium Fluoride 5000 ppm Enamel Protect — NDC 11527-0745-34," retrieved September 3, 2026, https://drugdashboards.com/drug/11527074534.

Free to cite with attribution — see how the data is put together.