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Prescription medicine · generic available

Hydrocortisone butyrate

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

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 Hydrocortisone butyrate used for?
The FDA-approved label (Hydrocortisone Butyrate, Oceanside Pharmaceuticals, December 31, 2020) says: “Hydrocortisone Butyrate Ointment, 0.1% is 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 butyrate have a boxed warning?
No. None of the 5 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Hydrocortisone butyrate?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Hydrocortisone butyrate been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Hydrocortisone butyrate?
6 companies list prescription products of Hydrocortisone butyrate in the FDA NDC Directory, including Sun Pharmaceutical Industries, Inc., Bryant Ranch Prepack and The J. Molner Company LLC.

What Hydrocortisone butyrate is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Hydrocortisone Butyrate Ointment, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

— FDA label: Hydrocortisone Butyrate, Oceanside Pharmaceuticals, effective December 31, 2020. Read the full label on DailyMed →

The FDA has 5 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 5 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsLotion · Ointment · Solution · Cream
RouteTopical
Prescription products8 in the FDA NDC Directory
Brand namesEvesse

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 Hydrocortisone butyrate, by strength and form
Strength and formGeneric or brandPharmacies pay
hydrocortisone butyrate 0.1%
cream
Generic $2.31–$2.50 per gram
2 packages, lowest to highest
hydrocortisone butyrate 0.1%
ointment
Generic $2.04–$2.18 per gram
2 packages, lowest to highest
hydrocortisone butyrate 1 mg/mL
lotion
Generic $0.6999 per mL
hydrocortisone butyrate 1 mg/mL
solution
Generic $2.05 per mL

NADAC list of November 4, 2026; these prices took effect between July 22, 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.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA018652
LOCOID
Precision DermatOctober 29, 1982 6, latest October 30, 2014
2014: Labeling · 2013: Manufacturing (CMC) · 1996: Manufacturing (CMC)

Generic approvals (5)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

RxCUI (RxNorm)1370758, 1370763, 1370767, 1370770, 2742561
SPL set ID of the quoted label7c3f8417-7861-41e3-876f-9b82aff7d1a0
FDA labels (SPL)5
FDA applicationsNDA018652, 5 ANDA
Active ingredients (FDA)HYDROCORTISONE BUTYRATE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Hydrocortisone Butyrate, Oceanside Pharmaceuticals, effective December 31, 2020; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (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. 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 →

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