Quick answers
- What is Phenylephrine Hci?
- Phenylephrine Hci is a brand name of Phenylephrine, a prescription medicine. The FDA NDC Directory lists 1 Phenylephrine Hci product in 1 strength and form.
- Who makes Phenylephrine Hci?
- Hikma holds the FDA application for Phenylephrine Hci (NDA203826, approved December 20, 2012).
- Is there a generic or store brand of Phenylephrine Hci?
- Yes. The FDA NDC Directory lists 66 other products with the same active ingredients, strength and form as a Phenylephrine Hci product, 59 of them generic. Ask your pharmacist whether one is right for you.
- Has Phenylephrine Hci been recalled?
- No recall linked to Phenylephrine Hci products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Phenylephrine Hci is
Each Phenylephrine Hci 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.
Phenylephrine · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| phenylephrine hydrochloride 10 mg/mL injection (intravenous) | Phenylephrine Hci | 66 products, 28 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Phenylephrine →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA203826 | Hikma | December 20, 2012 | 1 |
Companies that list Phenylephrine Hci
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Phenylephrine Hci products.
Recalls
No recall linked to Phenylephrine Hci products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- 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 labeling (SPL, 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
- 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.