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Brand-name prescription medicine

Proctofoam Hc

Generic name: Hydrocortisone acetate and pramoxine hydrochloride

FDA application holder: Mylan Speciality LP

Official data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the NDC Directory, Drugs@FDA, the official labels and recall reports; pharmacy costs come from the Centers for Medicare & Medicaid Services (CMS). Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or switch any medicine, including a switch between a brand and a generic.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Quick answers

What is Proctofoam Hc?
Proctofoam Hc is a brand name of Hydrocortisone acetate and pramoxine hydrochloride, a prescription medicine. The FDA NDC Directory lists 1 Proctofoam Hc product in 1 strength and form.
Who makes Proctofoam Hc?
Mylan Speciality LP holds the FDA application for Proctofoam Hc (ANDA086195, approved July 26, 1978).
Is there a generic or store brand of Proctofoam Hc?
Yes. The FDA NDC Directory lists 1 other product with the same active ingredients, strength and form as a Proctofoam Hc product, 1 of them generic. Ask your pharmacist whether one is right for you.
What do pharmacies pay for Proctofoam Hc?
CMS lists a National Average Drug Acquisition Cost (NADAC) for 1 Proctofoam Hc strength and form (see the table below). That is what pharmacies pay to buy it, not what you pay: your price depends on your insurance and your pharmacy.
Has Proctofoam Hc been recalled?
FDA enforcement reports list 2 recalls of Proctofoam Hc products; the newest started January 21, 2022. A recall usually concerns specific lots, not every product.

What Proctofoam Hc is

Each Proctofoam Hc product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.

Hydrocortisone acetate and pramoxine hydrochloride · prescription medicine

Strength and formProduct namesSame medicine, other namesLabel
hydrocortisone acetate 100 mg/10 g · pramoxine hydrochloride 100 mg/10 g
aerosol, foam (topical)
Proctofoam Hc 1 product, 1 company DailyMed

Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Hydrocortisone acetate and pramoxine hydrochloride →

FDA approval

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
FDA applications of Proctofoam Hc products (Drugs@FDA)
ApplicationHolderFirst approvedProducts
ANDA086195Mylan Speciality LPJuly 26, 19781

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Proctofoam Hc, by strength and form
Strength and formGeneric or brandPharmacies pay
hydrocortisone acetate 100 mg/10 g · pramoxine hydrochloride 100 mg/10 g
aerosol, foam
Brand: Proctofoam Hc $19.38 per gram

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list Proctofoam Hc

The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Proctofoam Hc products.

Recalls

From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. January 21, 2022 · Class II · Terminated · D-0452-2022

    cGMP deficiencies

    Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol, 10 g aerosol containers, Rx Only, Distributed by Meda Pharmaceuticals Inc, Somerset, New Jersey 08873-1120, NDC 0037-6822-10. — Mylan Pharmaceuticals Inc

  2. March 15, 2021 · Class II · Terminated · D-0529-2021

    CGMP Deviations: Intermittent exposure to temperature excursion during storage.

    Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol 10 g net wt Rx Only NDC 0037-6822-10 Distributed by: Meda Pharmaceutical Inc. Somerset, New Jersey — Cardinal Health Inc.

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026

Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.

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