Quick answers
- What is Hydrocortisone acetate and pramoxine hydrochloride used for?
- The FDA-approved label (Analpram HC, Legacy Pharma USA Inc., March 24, 2026) says: “INIDCATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Hydrocortisone acetate and pramoxine hydrochloride have a boxed warning?
- No. None of the 13 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Hydrocortisone acetate and pramoxine hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Hydrocortisone acetate and pramoxine hydrochloride been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started January 21, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Hydrocortisone acetate and pramoxine hydrochloride?
- 5 companies list prescription products of Hydrocortisone acetate and pramoxine hydrochloride in the FDA NDC Directory, including Legacy Pharma USA Inc., Bryant Ranch Prepack and Sebela Pharmaceuticals Inc..
What Hydrocortisone acetate and pramoxine hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
INIDCATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
— FDA label: Analpram HC, Legacy Pharma USA Inc., effective March 24, 2026. Read the full label on DailyMed →
The FDA has 13 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 13 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Cream · Lotion · Aerosol, foam |
|---|---|
| Route | Topical |
| Prescription products | 14 in the FDA NDC Directory |
| Brand names | Analpram Hc, Pramosone, Pramosone Cream, Proctofoam Hc, Epifoam |
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.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| hydrocortisone acetate 1% · pramoxine hydrochloride 1% cream | Generic | $2.97 per gram |
| hydrocortisone acetate 100 mg/10 g · pramoxine hydrochloride 100 mg/10 g aerosol, foam | Brand: Epifoam | $10.00 per gram |
| 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 between January 1, 2026 and 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 this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Legacy Pharma USA Inc.7 products
- Bryant Ranch Prepack2 products
- Sebela Pharmaceuticals Inc.2 products
- Viatris Specialty LLC2 products
- Padagis Israel Pharmaceuticals Ltd1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (5)
- ANDA085368Legacy · January 7, 1977
- ANDA085979Legacy · June 5, 1978
- ANDA085980Legacy · June 5, 1978
- ANDA086195Mylan Speciality LP · July 26, 1978
- ANDA086457Mylan Speciality LP · December 19, 1979
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
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
-
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.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Analpram HC, Legacy Pharma USA Inc., effective March 24, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →