Data / Drug companies / Hydrocortisone acetate
Hydrocortisone acetate: 35 companies and 51 products in the FDA NDC directory
Hydrocortisone acetate is listed in the FDA National Drug Code Directory by 35 companies, with 51 products in commercial distribution. 0 of the products (0.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are suppository; cream; ointment, and the newest product started marketing on August 28, 2026.
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- Companies listing it
- 35
- Products
- 51
- Generic (ANDA) products
- 0 (0.0%)
- Application numbers
- 3
- Routes
- Rectal, Topical
- Brand names
- American Safety and First Aid, Hemmorex-HC, Hydrocortisone, Hydrocortisone, Hair Sanity, Medi-First Hydrocortisone 1%, Medi-First 1% Hydrocortisone, Poli-A
- openFDA record search
- api.fda.gov
Companies that list hydrocortisone acetate
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Orazen Inc | 5 | cream | Over the counter monograph drugs | December 12, 2025 |
| Aarna USA Inc. | 2 | suppository | Other unapproved drugs | April 16, 2026 |
| Apnar Pharma LP | 2 | suppository | Other unapproved drugs | October 1, 2021 |
| Bryant Ranch Prepack | 2 | suppository | Other unapproved drugs | July 1, 1990 |
| Cosette Pharmaceuticals, Inc. | 2 | suppository | Other unapproved drugs | August 9, 2021 |
| Laser Pharmaceuticals, LLC | 2 | suppository | Other unapproved drugs | November 12, 2013 |
| Padagis US LLC | 2 | suppository | Other unapproved drugs | July 1, 1990 |
| Patrin Pharma, Inc. | 2 | suppository | Other unapproved drugs | January 1, 2022 |
| Rising Pharma Holdings, Inc. | 2 | suppository | Other unapproved drugs | March 1, 2024 |
| Salix Pharmaceuticals, Inc. | 2 | suppository | Other unapproved drugs | June 1, 2004 |
| Unifirst First Aid Corporation | 2 | cream | Over the counter monograph drugs | June 1, 2021 |
| Walgreen Company | 2 | cream | Over the counter monograph drugs | February 28, 2024 |
| Westminster Pharmaceuticals, LLC | 2 | suppository | Other unapproved drugs | November 25, 2024 |
| A-S Medication Solutions | 1 | suppository | Other unapproved drugs | February 5, 2020 |
| AvPAK | 1 | suppository | Other unapproved drugs | January 17, 2017 |
| Bentlin Products LLC | 1 | cream | Over the counter monograph drugs | January 24, 2007 |
| Combe Incorporated | 1 | cream | Over the counter monograph drugs | January 30, 2016 |
| Gentell LLC | 1 | cream | Over the counter monograph drugs | August 21, 2026 |
| Golden State Medical Supply, Inc. | 1 | suppository | Other unapproved drugs | November 12, 2013 |
| Hair Sense Holdings LLC | 1 | shampoo | Over the counter monograph drugs | February 9, 2026 |
| Hart Health | 1 | cream | Over the counter monograph drugs | January 1, 1974 |
| JHK Inc DBA American Safety & First Aid | 1 | cream | Over the counter monograph drugs | February 2, 2000 |
| Major Pharmaceuticals | 1 | suppository | Other unapproved drugs | April 5, 2024 |
| Marlex Pharmaceuticals, Inc. | 1 | suppository | Other unapproved drugs | August 1, 2022 |
| Nivagen Pharmaceuticals, Inc. | 1 | suppository | Other unapproved drugs | May 15, 2020 |
| NuCare Pharmaceuticals,Inc. | 1 | suppository | Other unapproved drugs | February 5, 2020 |
| Preferred Pharmaceuticals Inc. | 1 | suppository | Other unapproved drugs | August 28, 2026 |
| Proficient Rx LP | 1 | suppository | Other unapproved drugs | February 5, 2020 |
| Quagen Pharmaceuticals LLC | 1 | suppository | Other unapproved drugs | July 18, 2022 |
| Rite Aid Corporation | 1 | cream | Over the counter monograph drugs | January 28, 2022 |
| Sato Pharmaceutical Co., Ltd. | 1 | ointment | Over the counter monograph drugs | March 19, 1995 |
| Sun Pharmaceutical Industries, Inc. | 1 | cream | Over the counter monograph drugs | June 1, 2001 |
| The Honey Pot Company LLC | 1 | cream | Over the counter monograph drugs | March 1, 2022 |
| Twin Med LLC | 1 | ointment | Over the counter monograph drugs | February 5, 2013 |
| Viatris Specialty LLC | 1 | aerosol, foam | New drug applications (NDA) | June 15, 2015 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Suppository | 30 | 58.8% |
| Cream | 17 | 33.3% |
| Ointment | 2 | 3.9% |
| Shampoo | 1 | 2% |
| Aerosol, foam | 1 | 2% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Other unapproved drugs | 30 | 58.8% |
| Over the counter monograph drugs | 20 | 39.2% |
| New drug applications (NDA) | 1 | 2% |
Pharmacologic classes
| Class | Products |
|---|---|
| Corticosteroid | 51 |
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.