DrugDashboards

Rohto Cool Relief

Naphazoline hydrochloride, Polysorbate 80 · NAPHAZOLINE HYDROCHLORIDE .12 mg/mL; POLYSORBATE 80 2 mg/mL · Liquid · Ophthalmic · The Mentholatum Company

NDC 10742-8141-01 · 1 BOTTLE, WITH APPLICATOR in 1 CARTON / 13 mL in 1 BOTTLE, WITH APPLICATOR · OTC MONOGRAPH DRUG · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles. A Class II recall hit this product in the past year (Rohto-Mentholatum (Vietnam) Co., Ltd.).

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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.

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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.

Regulatory

Application
M018
TE code
Approval date
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · OngoingJul 14, 2026
    Rohto-Mentholatum (Vietnam) Co., Ltd.Lack of Assurance of Sterility

Manufacturers of Naphazoline hydrochloride, Polysorbate 80 (Liquid)

LabelerStrengthFirst seenLast seen
The Mentholatum CompanyNAPHAZOLINE HYDROCHLORIDE .12 mg/mL; POLYSORBATE 80 2 mg/mLJul 15, 2026Sep 2, 2026
The Mentholatum CompanyNAPHAZOLINE HYDROCHLORIDE .3 mg/mL; POLYSORBATE 80 2 mg/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Rohto Cool Relief — NDC 10742-8141-01," retrieved September 3, 2026, https://drugdashboards.com/drug/10742814101.

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