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Prescription medicine · generic available

Phenylephrine

Brand names: Biorphen, Immphentiv, Phenylephrine Hci

Also listed by the FDA as: phenylephrine hydrochloride · phenylephrine

Also sold without a prescription: Phenylephrine (over the counter) →

Drug class: alpha-1 Adrenergic Agonist

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

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.

At a glance

NoBoxed warning
None listedFDA shortage list
1Recalls (FDA reports)
37Companies
2012First FDA approval on file

Quick answers

What is Phenylephrine used for?
The FDA-approved label (Phenylephrine Hydrochloride, Hikma Pharmaceuticals USA Inc., August 19, 2026) says: “IMMPHENTIV injection 100 mcg/mL is indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. Phenylephrine Hydrochloride Injection 10 mg/mL is indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the settings of anesthesia and septic shock. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Phenylephrine have a boxed warning?
No. None of the 57 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Phenylephrine?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Phenylephrine been recalled?
FDA enforcement reports list 1 recall of products of this medicine; the newest started March 11, 2021 (Class II). A recall usually concerns specific lots, not every product.
Who makes Phenylephrine?
37 companies list prescription products of Phenylephrine in the FDA NDC Directory, including Somerset Therapeutics, LLC, Lifestar Pharma LLC and Hikma Pharmaceuticals USA Inc..

What Phenylephrine is used for

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

IMMPHENTIV injection 100 mcg/mL is indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. Phenylephrine Hydrochloride Injection 10 mg/mL is indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the settings of anesthesia and septic shock. …

— FDA label: Phenylephrine Hydrochloride, Hikma Pharmaceuticals USA Inc., effective August 19, 2026. Read the full label on DailyMed →

The FDA has 57 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 57 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsInjection · Solution/ drops · Injection, solution · Solution · Injectable, liposomal
RouteIntravenous · Ophthalmic
Prescription products113 in the FDA NDC Directory
Brand namesBiorphen, Immphentiv

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 Phenylephrine, by strength and form
Strength and formGeneric or brandPharmacies pay
phenylephrine hydrochloride 100 mg/mL
solution		 Generic $5.27 per mL
phenylephrine hydrochloride 100 mg/mL
solution/ drops		 Generic $5.27 per mL
phenylephrine hydrochloride 25 mg/mL
solution		 Generic $9.08 per mL
phenylephrine hydrochloride 25 mg/mL
solution/ drops		 Generic $9.08 per mL

NADAC list of November 4, 2026; these prices took effect on 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
NDA203510
PHENYLEPHRINE HYDROCHLORIDE		 Paragon BioteckMarch 21, 2013 3, latest December 8, 2022
2022: Manufacturing (CMC) · 2020: Labeling · 2013: Manufacturing (CMC)
NDA203826
IMMPHENTIV, PHENYLEPHRINE HYDROCHLORIDE		 HikmaDecember 20, 2012 7, latest March 9, 2023
2023: Manufacturing (CMC) · 2023: Labeling · 2019: Manufacturing (CMC)
NDA207926
PHENYLEPHRINE HYDROCHLORIDE		 AlconJanuary 15, 2015 2, latest March 13, 2025
2025: Manufacturing (CMC) · 2019: Labeling
NDA212909
BIORPHEN		 DR Reddys Labs SAOctober 21, 2019 2, latest April 12, 2024
2024: Manufacturing (CMC) · 2021: Efficacy
NDA216830
PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE		 DR Reddys Labs SAMay 30, 2025 —

Generic approvals (25)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

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.

  1. March 11, 2021 · Class II · Terminated · D-0305-2021

    Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.

    Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25 x 1 mL Single-Dose Vials per carton, For Intravenous Use, Rx only, Mfd. for: SAGENT Pharmaceuticals, Schaumburg, IL 60195; Made in — Sagent Pharmaceuticals 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

RxCUI (RxNorm)1232651, 1234571, 1234579, 1666372, 2262018, 2533434, 2533437, 2634228, 2634233, 2634235 … (+1)
SPL set ID of the quoted labele1a7ab4b-0afe-4463-a039-5be0323cf2f7
FDA labels (SPL)57
FDA applicationsNDA203510, NDA203826, NDA207926, NDA212909, NDA216830, 25 ANDA
Active ingredients (FDA)PHENYLEPHRINE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Phenylephrine Hydrochloride, Hikma Pharmaceuticals USA Inc., effective August 19, 2026; 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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