DrugDashboards

Sore No More Warm Therapy

MENTHOL and CAMPHOR · MENTHOL .03 g/g; CAMPHOR (SYNTHETIC) .03 g/g · Gel · Topical · Sombra Cosmetics Inc.

NDC 61577-3234-02 · 907.2 g in 1 BOTTLE, PUMP · OTC MONOGRAPH DRUG · View full market →

The short version

Just 2 companies supply this market — thin enough that a single exit would be felt immediately. One of its named manufacturing plants, Sombra Cosmetics Inc., failed FDA inspectionwithin the last two years — the agency’s most serious outcome.

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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 camphor, menthol (other) in the next 90 days

OAI inspection at a producing facility (24 months) · sole-source market · price up 3% YoY

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
M017
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 MENTHOL and CAMPHOR (Gel)

LabelerStrengthFirst seenLast seen
Richtofit Limited Liability CompanyMENTHOL 5 g/100g; CAMPHOR (SYNTHETIC) 4 g/100gAug 26, 2026Sep 2, 2026
Sombra Cosmetics Inc.MENTHOL .03 g/g; CAMPHOR (SYNTHETIC) .03 g/gJul 22, 2026Sep 2, 2026
Richtofit Limited Liability CompanyMENTHOL 4 g/100g; CAMPHOR (SYNTHETIC) 5 g/100gJul 22, 2026Aug 19, 2026
Richtofit Limited Liability CompanyCAMPHOR (SYNTHETIC) 4 g/100g; MENTHOL 5 g/100gJul 15, 2026Jul 15, 2026
Sombra Cosmetics Inc.CAMPHOR (SYNTHETIC) .03 g/g; MENTHOL .03 g/gJul 15, 2026Jul 15, 2026

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

Cite this page

DrugDashboards, "Sore No More Warm Therapy — NDC 61577-3234-02," retrieved September 3, 2026, https://drugdashboards.com/drug/61577323402.

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