Prescription and over-the-counter medicine
Phenylephrine Brand names: Immphentiv, Biorphen
Phenylephrine (Biorphen) is a prescription and over-the-counter medicine with an FDA approval on record since 2012. On November 7, 2024 the FDA proposed removing oral phenylephrine from the over-the-counter nasal decongestant monograph, finding it not effective as a nasal decongestant when taken by mouth. FDA's NDC Directory lists it from 33 generic labelers, and pharmacies paid $5.24 per mL (Phenylephrine 10% eye drop) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the phenylephrine FDA label on DailyMed (effective August 19, 2026, Hikma Pharmaceuticals USA Inc.); the NDA 203826 record on Drugs@FDA; every phenylephrine label on DailyMed.
Highlights of the record
FDA label of August 19, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageIMMPHENTIV 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.
Forms and strengths
- 0.1 mg/ml
- 10 mg/ml
- 25 mg/ml
- 50 mg/5ml
- 100 mg/ml
- 100 mg/10ml
Injection; solution/ drops; injection (solution); solution; injectable (liposomal).
On the market
- Earliest approval on file
- December 20, 2012 Immphentiv, Hikma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 27 first April 27, 2018; 26 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 39 of which 33 under generic applications, 7 under brand applications, repackagers included; 59 more under the over-the-counter monograph, without an application
- Last listed patent
- August 8, 2044 Phenylephrine Hydrochloride In 0.9% Sodium Chloride injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $5.24 per mL Phenylephrine 10% eye drop
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 90 since 2013 10 Class I among all firms' recalls; latest April 1, 2026; 22 more by firms not listed as its makers
- FAERS reports
- 3,736 through July 30, 2026
What is phenylephrine used for?
From the label: indications and usageIMMPHENTIV 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. IMMPHENTIV injection 100 mcg/mL is an alpha-1 adrenergic receptor agonist indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. […]
Conditions named in the indications of phenylephrine's FDA labels, with every medicine labeled for each:
From other phenylephrine labelsCough and cold: • common cold
Allergies: upper respiratory allergies
FDA pharmacologic class: alpha-1 Adrenergic Agonist.
Source: FDA drug label (Phenylephrine Hydrochloride), Hikma Pharmaceuticals USA Inc., effective August 19, 2026 (SPL set e1a7ab4b-0afe-4463-a039-5be0323cf2f7), via openFDA; the full label on DailyMed
Is there a generic for phenylephrine (Biorphen)?
The FDA approved the first generic phenylephrine on April 27, 2018. 27 generic applications are approved; 26 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists phenylephrine from 33 labelers under a generic (ANDA) application and from 7 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Biorphen injection; a patent listed only for Phenylephrine Hydrochloride In 0.9% Sodium Chloride injection runs to August 8, 2044. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2012 earliest approval on file
- 2018 first generic approved
- 2044 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for phenylephrine (Biorphen)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $5.24 per mL (Phenylephrine 10% eye drop). Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Phenylephrine 10% eye drop (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Ft nasal decong PE 10 mg tablet | Generic | $0.0496 per tablet | $1.49 | -0.2% |
| Gs nasal four 1% nasal spray | Generic | $0.0672 per mL | n/a | -17% |
| Phenylephrine 10% eye drop | Generic | $5.24 per mL | n/a | n/a |
| Phenylephrine 2.5% eye drop | Generic | $9.29 per mL | n/a | -24% |
| Qc nasal spray 1% | Generic | $0.0703 per mL | n/a | +2% |
| Qc sinus congest PE 10 mg tablet | Generic | $0.0496 per tablet | $1.49 | -0.2% |
| Sinus relief 1% nasal spray | Generic | $0.0703 per mL | n/a | +2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What has the FDA said about oral phenylephrine?
The FDA proposed removing oral phenylephrine from the over-the-counter monograph for nasal decongestants on November 7, 2024: the agency's review of the evidence found that oral phenylephrine does not work as a nasal decongestant; the proposal does not concern phenylephrine nasal sprays or the injection used in hospitals; it is a proposal; this page records no final order.
FDA's NDC Directory lists phenylephrine from 39 labelers under FDA applications, 33 of them generic, and 59 more labelers under the over-the-counter monograph, as read October 8, 2026; a listing is the maker's registration, not proof that a product is sold. Status checked October 8, 2026.
Source: FDA announcement of November 7, 2024
Has phenylephrine been recalled?
The FDA's Enforcement Report lists 112 recalls naming phenylephrine since 2013: 10 Class I (the most serious), 100 Class II, 2 Class III; 7 still ongoing. 22 of them are by firms that FDA's NDC Directory does not list as a maker of phenylephrine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 1, 2026 | Class II | Wells Pharma of Houston LLC | cGMP deviations. |
| January 21, 2025 | Class I | Provepharm Inc. | Presence of Particulate Matter. |
| February 29, 2024 | Class II | SSM Health Care St. Louis DBA SSM St. Clare Health Center not a listed maker | Lack of Assurance of Sterility: Firm did not perform process validation. |
| December 28, 2023 | Class I | Denver Solutions, LLC DBA Leiters Health | Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. |
| November 9, 2023 | Class II | SCA Pharmaceuticals, LLC | Lack of Assurance of Sterility |
| August 17, 2023 | Class II | Central Admixture Pharmacy Services, Inc. | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles |
| July 14, 2023 | Class II | Central Admixture Pharmacy Services, Inc. | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. |
| July 10, 2023 | Class II | New England Life Care, Inc. dba Advanced Compounding … not a listed maker | CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the phenylephrine label say about other medicines?
The phenylephrine label names 10 other medicines in its interaction, contraindication or warning sections. The labels of 8 other medicines name phenylephrine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amiodarone | drug interactions | Antagonists α-adrenergic blocking agents, including phenothiazines (e.g., chlorpromazine) and amiodarone block phenylephrine and are in turn blocked by phenylephrine. |
| Atomoxetine | drug interactions | … agonists, such as clonidine Steroids Tricyclic antidepressants Norepinephrine transport inhibitors, such as atomoxetine Ergot alkaloids, such as methylergonovine maleate Centrally-acting sympatholytic agents, such as guanfacine or reserpine Atropine sulfate |
| Atropine | drug interactions | DRUG INTERACTIONS Agonistic effects with monoamine oxidase inhibitors (MAOI), β-adrenergic blocking agents, α-2 adrenergic agonists, steroids, tricyclic antidepressants, norepinephrine transport inhibitors, ergot alkaloids, centrally-acting sympatholytic agents and atropine sulfate ( 7.1 ) Antagonistic effects on and … |
| Chlorpromazine | drug interactions | Antagonists α-adrenergic blocking agents, including phenothiazines (e.g., chlorpromazine) and amiodarone block phenylephrine and are in turn blocked by phenylephrine. |
| Clonidine | drug interactions | The pressor effect of phenylephrine hydrochloride is increased in patients receiving: Monoamine oxidase inhibitors (MAOI), such as selegiline. β-adrenergic blockers α-2 adrenergic agonists, such as clonidine Steroids Tricyclic antidepressants Norepinephrine transport inhibitors, such as atomoxetine Ergot alkaloids … |
| Guanfacine | drug interactions | … atomoxetine Ergot alkaloids, such as methylergonovine maleate Centrally-acting sympatholytic agents, such as guanfacine or reserpine Atropine sulfate |
| Hydrocortisone | drug interactions | Monoamine oxidase inhibitors (MAOI) Oxytocin and oxytocic drugs Tricyclic antidepressants Angiotensin, aldosterone Atropine Steroids, such as hydrocortisone Norepinephrine transporter inhibitors, such as atomoxetine Ergot alkaloids, such as methylergonovine maleate |
| Methylergonovine | drug interactions | … Tricyclic antidepressants Norepinephrine transport inhibitors, such as atomoxetine Ergot alkaloids, such as methylergonovine maleate Centrally-acting sympatholytic agents, such as guanfacine or reserpine Atropine sulfate |
| Nifedipine | drug interactions | Interactions that Antagonize the Pressor Effect The increasing blood pressure effect of BIORPHEN is decreased in patients receiving: α-adrenergic antagonists Phosphodiesterase Type 5 inhibitors Mixed α- and β-receptor antagonists Calcium channel blockers, such as nifedipine Benzodiazepines ACE inhibitors Centrally … |
| Selegiline | drug interactions | The pressor effect of phenylephrine hydrochloride is increased in patients receiving: Monoamine oxidase inhibitors (MAOI), such as selegiline. β-adrenergic blockers α-2 adrenergic agonists, such as clonidine Steroids Tricyclic antidepressants Norepinephrine transport inhibitors, such as atomoxetine Ergot alkaloids … |
Other labels that name phenylephrine
Source: FDA drug label (Phenylephrine Hydrochloride), Hikma Pharmaceuticals USA Inc., effective August 19, 2026 (SPL set e1a7ab4b-0afe-4463-a039-5be0323cf2f7), via openFDA; the full label on DailyMed
What do FAERS reports show for phenylephrine?
The FDA Adverse Event Reporting System holds 3,736 reports that list phenylephrine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,739 are coded as a death and 2,112 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (1,006, against a median of 115 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
How does phenylephrine compare with medicines for the same use?
3 side-by-side pages set phenylephrine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Other alpha-1 adrenergic agonists
- the pharmacologic class, with prices and generics
- Phenylephrine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other