Data / Drug companies / Pseudoephedrine hcl
Pseudoephedrine hcl: 29 companies and 42 products in the FDA NDC directory
Pseudoephedrine hcl is listed in the FDA National Drug Code Directory by 29 companies, with 42 products in commercial distribution. 8 of the products (19.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated; tablet, film coated, extended release; tablet, and the newest product started marketing on September 15, 2026.
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- Companies listing it
- 29
- Products
- 42
- Generic (ANDA) products
- 8 (19.0%)
- Application numbers
- 3
- Routes
- Oral
- Brand names
- Nasal Decongestant, Pseudoephedrine Hydrochloride, Nasal Decongestant Maximum Strength, CareOne Nasal and Sinus Decongestant, Sinus Pressure and Congestion Relief Maximum Strength, Sinus and Nasal Decongestant, SudoGest, Sinus 12 Hour
- openFDA record search
- api.fda.gov
Companies that list pseudoephedrine hcl
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Major Pharmaceuticals | 5 | tablet, film coated; tablet, film coated, extended release | Over the counter monograph drugs | September 15, 2026 |
| A-S Medication Solutions | 3 | tablet, film coated | Over the counter monograph drugs | October 17, 2008 |
| American Sales Company | 2 | tablet, film coated, extended release; tablet, film coated | Generic drugs (ANDA) | September 25, 2017 |
| CVS Pharmacy | 2 | tablet, film coated | Over the counter monograph drugs | July 15, 1987 |
| Cardinal Health 110, LLC. DBA Leader | 2 | tablet, film coated, extended release; tablet, film coated | Generic drugs (ANDA) | August 7, 2025 |
| L. Perrigo Company | 2 | tablet, film coated, extended release; tablet, film coated | Generic drugs (ANDA) | September 29, 2017 |
| Padagis Israel Pharmaceuticals Ltd | 2 | tablet, film coated, extended release; tablet, film coated | Generic drugs (ANDA) | May 24, 2014 |
| Rite Aid Corporation | 2 | tablet, film coated; tablet, film coated, extended release | Over the counter monograph drugs | August 30, 1999 |
| Safeway | 2 | tablet, film coated; tablet, extended release | Over the counter monograph drugs | September 1, 2023 |
| Amerisource Bergen | 1 | tablet, film coated | Over the counter monograph drugs | August 25, 1981 |
| Aurohealth LLC | 1 | tablet, extended release | Generic drugs (ANDA) | June 9, 2017 |
| CVS Woonsocket Prescription Center, Incorporated | 1 | tablet, film coated | Over the counter monograph drugs | September 24, 2025 |
| Chain Drug Consortium, LLC | 1 | tablet, film coated | Over the counter monograph drugs | August 25, 1981 |
| Chain Drug Marketing Association | 1 | tablet, film coated | Over the counter monograph drugs | August 25, 1981 |
| Chain Drug Marketing Association, Inc. | 1 | tablet, film coated | Over the counter monograph drugs | November 7, 2025 |
| H E B | 1 | tablet, film coated | Over the counter monograph drugs | August 25, 1981 |
| Kroger Company | 1 | tablet, film coated | Over the counter monograph drugs | April 13, 2021 |
| L.N.K. International, Inc. | 1 | tablet, film coated | Over the counter monograph drugs | August 25, 1981 |
| Meijer Distribution Inc | 1 | tablet, film coated | Over the counter monograph drugs | February 15, 1991 |
| Proficient Rx LP | 1 | tablet | Over the counter monograph drugs | October 29, 2012 |
| Proficient Rx LP | 1 | tablet, film coated | Over the counter monograph drugs | October 17, 2008 |
| Publix Super Markets Inc | 1 | tablet, film coated | Over the counter monograph drugs | September 9, 1993 |
| Rugby Laboratories | 1 | tablet | Over the counter monograph drugs | October 29, 2012 |
| Sportpharm LLC | 1 | tablet, film coated | Over the counter monograph drugs | October 17, 2008 |
| Strategic Sourcing Services LLC | 1 | tablet, film coated | Over the counter monograph drugs | April 6, 2023 |
| Topco Associates LLC | 1 | tablet, film coated | Over the counter monograph drugs | January 15, 1988 |
| United Natural Foods, Inc. DBA Unfi | 1 | tablet, film coated | Over the counter monograph drugs | August 17, 2004 |
| Wal-Mart Stores Inc | 1 | tablet, film coated | Over the counter monograph drugs | July 15, 2020 |
| Walgreen Company | 1 | tablet, film coated | Over the counter monograph drugs | August 25, 1981 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated | 32 | 76.2% |
| Tablet, film coated, extended release | 6 | 14.3% |
| Tablet | 2 | 4.8% |
| Tablet, extended release | 2 | 4.8% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Over the counter monograph drugs | 34 | 81% |
| Generic drugs (ANDA) | 8 | 19% |
Pharmacologic classes
| Class | Products |
|---|---|
| alpha-Adrenergic Agonist | 42 |
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.