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Phenylephrine

Phenylephrine is an alpha-1 agonist (a drug that tightens blood vessels) used as an IV injection to raise low blood pressure during anesthesia or septic shock, as eye drops to dilate the pupil, as a nasal spray or tablet for congestion, and as a rectal suppository for hemorrhoids.

Brand names Children's Sudafed PE Nasal DecongestantLusonalPediaCare Children's DecongestantSudafed PE CongestionSuphedrin PE +11 more
Drug class Alpha-1 Adrenergic Agonist
Rx/OTC Forms 6
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 55 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

How we combine label and product data →
✓No current FDA shortage listed · checked Oct 4, 2026
Other forms & routes:
Phenylephrine at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Phenylephrine is an alpha-1 agonist (it tightens blood vessels), sold over the counter as the decongestant in Sudafed PE and many cold products. It is also used as pupil-widening eye drops, as hemorrhoid suppositories and as a hospital injection for low blood pressure during anesthesia or septic shock; on the market since about 1981, it is available generically. The home products are usually well tolerated, though headache, nausea, nervousness or poor sleep can show up. Never use it with an MAOI (certain antidepressants and Parkinson’s drugs) or within 2 weeks of stopping one. The injection is given only by healthcare professionals with close monitoring, especially for people with heart failure or angina.

Clinical pearls

  • Evidence that swallowed phenylephrine relieves a stuffy nose is weak, so never raise the dose when tablets seem to do nothing.
  • Many multi-symptom cold and flu products already contain phenylephrine, so check labels before adding a separate decongestant.
  • With high blood pressure, heart or thyroid disease, diabetes or an enlarged prostate, ask your pharmacist before using the decongestant.
  • Stop the over-the-counter products and get checked if symptoms last more than 7 days or come with a fever.
How you get itPrescription and over the counter
Comes asTablet, Injection, Nasal spray +3
Earliest FDA record1952
Companies listing it with the FDA165
FDA label last updatedMay 26, 2026
FDA’s strongest warning (boxed)None on the label

Patient information guide — a plain-language walkthrough of Phenylephrine, written from its FDA label.

What Phenylephrine is used for

▾

Phenylephrine is used in several forms, and each has its own approved use.

  • Injection (IV): raises blood pressure in adults with clinically important hypotension from vasodilation during anesthesia. Some labels also include septic shock.
  • Eye drops: dilate the pupil.
  • Nasal products: temporarily relieve congestion from the common cold, hay fever or upper respiratory allergies, plus sinus congestion and pressure.
  • Rectal suppositories: relieve itching and discomfort from hemorrhoids and shrink hemorrhoidal tissue.

How Phenylephrine works

▾

Phenylephrine is an alpha-1 adrenergic receptor agonist. It switches on alpha-1 receptors on blood vessel muscle cells, which makes the vessels narrow. By IV, this raises blood pressure.

Phenylephrine dosage

▾

How Phenylephrine is used depends on the product. Follow your prescriber and the label.

  • Injection: given by a healthcare professional into a vein as a bolus or infusion, with dosing adjusted to blood pressure response. Some products must be diluted, while others are ready to use.
  • Eye drops: a single drop at a time, repeated at short intervals up to a set maximum.
  • Preparation H suppository: inserted rectally up to 4 times daily.

Dosing details from the FDA-approved label

From the Phenylephrine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Treatment of hypotension during anesthesia - bolus intravenous injection
    • Initial dose 40 mcg to 100 mcg by intravenous bolus
    • Additional boluses may be administered every 1 to 2 minutes as needed
    • Adjust the dose according to the pressor response (titrate to effect)
    • Maximum: Not to exceed a total dosage of 200 mcg
    • Phenylephrine hydrochloride injection 10 mg/mL must be diluted before administration; Biorphen 500 mcg/5 mL (100 mcg/mL) must not be diluted (ready-to-use)
  • Treatment of hypotension during anesthesia - continuous intravenous infusion (10 mg/mL product)
    • If blood pressure is below the target goal, start a continuous intravenous infusion at 10 mcg/min to 35 mcg/min, titrating to effect
    • Adjust dosage according to the blood pressure goal
    • Maximum: Not to exceed 200 mcg/min
    • Dilute 10 mg/mL with normal saline or 5% dextrose in water; diluted solution not held more than 4 hours at room temperature or more than 24 hours refrigerated
Read the label’s full dosing text

Directions find right dose on chart below mL = milliliter repeat dose every 4 hours do not use more than 6 times in 24 hours Age (yr) Dose (mL) under 4 years do not use 4 to 5 years 5 mL 6 to 11 years 10 mL Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Read the full Dosage and Administration section on DailyMed →

Phenylephrine side effects

▾

Common side effects

  • Nausea
  • Vomiting
  • Headache
  • Blurred vision
  • Tremors
  • Itching
  • Neck pain

When to get medical help

  • Chest pain (angina) or worsening heart failure
  • Very slow heart rate (severe bradycardia) or reduced blood flow from the heart
  • Signs of poor blood flow to the hands, feet or organs
  • Pain, swelling or skin damage at the IV site, which may mean the drug leaked out of the vein
  • Allergic-type reactions, including asthma episodes, from the sulfite in some products
  • Very high blood pressure (hypertensive crisis) or irregular heartbeats
  • Nervousness, dizziness or sleeplessness with over-the-counter products
  • Symptoms that last more than 7 days or come with a fever (over-the-counter products)

Injection side effects are mostly from too much drug effect.

  • Nausea
  • Vomiting
  • Headache
  • Blurred vision
  • Tremors
  • Itching

Get help right away for chest pain, a very slow heartbeat, a sharp rise in blood pressure, or pain and skin changes at the IV site.

Phenylephrine warnings and precautions

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  • Heart and lung effects: can trigger angina, worsen heart failure and raise pressure in the lungs.
  • Poor blood flow: can reduce blood flow to the limbs and organs, especially with peripheral vascular disease.
  • Tissue damage: leakage from the vein can kill or damage tissue.
  • Slow heart rate: can be severe and reduce cardiac output.
  • Sulfites: some products can cause allergic-type reactions and asthma episodes.
  • Kidneys: in septic shock, it can increase the need for kidney replacement therapy.
  • Over-the-counter products: stop and ask a doctor if nervousness, dizziness or sleeplessness occurs, or if symptoms last more than 7 days or come with a fever.

Phenylephrine interactions

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Several drugs can raise or lower the blood pressure effect of the injection.

  • MAOIs: avoid over-the-counter products with these, or for 2 weeks after stopping. They also boost the injection's effect.
  • Oxytocin and similar drugs: can increase the effect, with risk of hemorrhagic stroke.
  • Tricyclic antidepressants, atropine, steroids, atomoxetine, ergot alkaloids: can increase the effect.
  • Alpha-blockers, PDE5 inhibitors, calcium channel blockers, ACE inhibitors, benzodiazepines: can reduce the effect.

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Phenylephrine

▾
  • Heart disease, high blood pressure, thyroid disease, diabetes or an enlarged prostate: ask a doctor before using over-the-counter products.
  • Sulfite sensitivity or asthma: some products contain a sulfite.
  • Pregnancy: ask a health professional first. For Cesarean section use, trials have not shown harm to mothers or babies' Apgar scores, but there are no data from the first or second trimester.
  • Breastfeeding: no data on the injection in breast milk.
  • Children: safety and effectiveness of the injection have not been established.
  • Older adults: dosing should start low.
  • Liver cirrhosis may require more drug. End stage kidney disease may require less.

Phenylephrine overdose

▾

Too much phenylephrine can cause a rapid rise in blood pressure. Symptoms include headache, vomiting, a feeling of fullness in the head, tingling in the hands or feet, slow heart rate and irregular heartbeats. For over-the-counter products, get medical help or call Poison Control at 1-800-222-1222 right away.

What Phenylephrine does in the body

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Phenylephrine narrows blood vessels and raises systolic and diastolic blood pressure. After an IV bolus the effect starts within minutes. As blood pressure rises, the heart rate can slow reflexively. It acts on most vascular beds, including those in the kidneys, lungs and gut.

How your body processes Phenylephrine

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After IV infusion, the effective half-life is about 5 minutes and the terminal half-life is about 2.5 hours. It spreads widely into tissues and is broken down mainly by monoamine oxidase and sulfotransferase. About 86% of a dose is recovered in urine within 48 hours, with 16% as unchanged drug. The metabolites are not considered active.

How to store Phenylephrine

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store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents are used.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

81

Supplements & herbs that interact with Phenylephrine

81 supplements and herbal products have documented interactions with Phenylephrine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 6
  • Moderate · 60
  • Minor · 15
Every supplement checked against Phenylephrine — ranked by severity The full interaction hub: 6 major · 60 moderate · 15 minor · every one linked to its full report. Check Phenylephrine against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Phenylephrine: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Phenylephrine — the kind of thing our pharmacy team would talk through with you at the counter.

What is phenylephrine used for?

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It depends on the product. The injection raises low blood pressure during anesthesia and, for some products, septic shock. Eye drops dilate the pupil, nasal products relieve congestion and suppositories treat hemorrhoid symptoms.

Can I take it with my antidepressant?

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Be careful. Over-the-counter phenylephrine should not be used with a prescription MAOI or within 2 weeks of stopping one. If you aren't sure whether your medicine is an MAOI, ask me or your doctor before using it.

What side effects should I expect?

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With the injection, the most common are nausea, vomiting and headache. Call for help right away if you have chest pain, a very slow heartbeat, or pain or skin changes around the IV site.

When should I stop using the over-the-counter products?

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Stop and talk to a doctor if you get nervousness, dizziness or sleeplessness. Also stop if symptoms last more than 7 days or come with a fever. Don't use more than the label recommends.

Do I need to check anything first if I have a health condition?

▾
Yes, for over-the-counter products. Ask a doctor first if you have heart disease, high blood pressure, thyroid disease, diabetes or trouble urinating from an enlarged prostate.

Is it safe in pregnancy?

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Ask a health professional before using it. For Cesarean section, studies have not shown harm to mothers or infant Apgar scores. There are no data from the first or second trimester.

Is Phenylephrine available over the counter?

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Both. Some Phenylephrine products are sold over the counter and others need a prescription. According to their FDA listings, the tablet, nasal spray, rectal suppository and oral solution forms are sold over the counter and the injection and eye drops forms need a prescription. The package says which kind you have. Your pharmacist can tell you which product is right for you.

When was Phenylephrine first available?

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The earliest FDA record we hold for Phenylephrine is from 1952: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Phenylephrine was first used.

Who makes Phenylephrine?

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165 companies list Phenylephrine products in the FDA's NDC Directory, including Hikma Pharmaceuticals USA Inc., Lifestar Pharma LLC, Spirit Pharmaceuticals LLC. That count includes repackagers and distributors as well as manufacturers, so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Phenylephrine on HelloPharmacist

Detailed data & references for Phenylephrine Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Phenylephrine forms and strengths (how it comes)

Phenylephrine is available in 6 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Sudafed PE Congestion Wal-Phed PE
Available strengths 3 strengths
198 FDA-listed product records ⓘ

Injection

Into a vein
Brands Biorphen Vazculep
How this form is used
What it may be used for
  • Biorphen is used to treat clinically important hypotension from vasodilation during anesthesia.
  • Immphentiv 100 mcg/mL is used to raise blood pressure in adults with hypotension from vasodilation during anesthesia.
  • Phenylephrine Hydrochloride Injection 10 mg/mL (Immphentiv label) is used for hypotension during anesthesia and septic shock.
Important instructions
  • Biorphen 100 mcg/mL is ready to use and must not be diluted. Biorphen 10 mg/mL must be diluted.
  • Immphentiv 100 mcg/mL must not be diluted before use.
  • Phenylephrine Hydrochloride injection 10 mg/mL products must be diluted before IV use.
  • Phenylephrine Hci is given by IV after dilution, and low fluid volume and acidosis should be corrected.
Available strengths 5 strengths
170 FDA-listed product records ⓘ

Nasal spray

In the nose
Brands Ephrine Nose Drops Equate Nasal Extra Strength Nasal Extra Strength Sinus Relief Nasal Decongestant Neo-Synephrine Maximum Neo-Synephrine Mild
How this form is used
What it may be used for
  • Neo-Synephrine Mild and Neo-Synephrine Maximum temporarily relieve nasal congestion from the common cold, hay fever or upper respiratory allergies.
  • Extra Strength Sinus Relief Nasal Decongestant temporarily relieves nasal and sinus congestion and pressure.
Available strengths 6 strengths
79 FDA-listed product records ⓘ

Eye drops

In the eye
How this form is used
What it may be used for
  • Phenylephrine Hydrochloride Ophthalmic Solution 2.5% and 10% is used to dilate the pupil.
Important instructions
  • Phenylephrine Hydrochloride Ophthalmic Solution is applied as one drop to the conjunctival fornix, repeated at 3 to 5 minute intervals up to a maximum of 3 drops per eye.
  • Phenylephrine Hydrochloride Ophthalmic Solution 10% may be used to get a greater degree of pupil dilation.
  • For babies under 1 year, the label specifies only the 2.5% strength.
Available strengths 3 strengths
42 FDA-listed product records ⓘ

Rectal suppository

Rectal
Brands Bliss Gvs Hemorrhoidal Preparation H ReVIVOL-XR up and up
How this form is used
What it may be used for
  • Preparation H helps relieve itching and discomfort from hemorrhoids and temporarily shrinks hemorrhoidal tissue.
  • ReVIVOL-XR temporarily relieves burning, shrinks hemorrhoidal tissue and coats irritated anorectal surfaces.
Important instructions
  • Preparation H is inserted into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement.
  • Preparation H: remove the foil wrapper first. Clean and dry the area before insertion.
  • Preparation H: children under 12 should see a doctor.
Available strengths 1 strength
7 FDA-listed product records ⓘ

Phenylephrine on the U.S. market: products, makers and brands

How Phenylephrine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

165 companies list 525 Phenylephrine product records with the FDA, mostly as tablet, injection, nasal spray; the earliest marketing or approval year on record is 1952. Brand names on the directory include Children's Sudafed PE Nasal Decongestant, Lusonal, PediaCare Children's Decongestant and 13 more; the rest are generics.

6
Dose forms ⓘ
165
Labelers (makers, repackagers, distributors)
40
Brand names
525
FDA-listed product records ⓘ
1952
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (24) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Hikma Pharmaceuticals USA Inc.7%
Lifestar Pharma LLC6%
Spirit Pharmaceuticals LLC5%
Medical Purchasing Solutions, LLC4%
CVS Pharmacy4%
Unifirst First Aid Corporation3%
Other makers71%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Phenylephrine is used (Medicaid data)

A general measure of how commonly Phenylephrine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Phenylephrine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

17,563
Medicaid prescriptions filled (Q1–Q4 2025)
$2.2M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Phenylephrine prescribed? Of the 1,601 medications we measure, Phenylephrine ranks #822 by Medicaid prescriptions — more than 49% of them.

Where Phenylephrine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Phenylephrine product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 1 mL / 10 mg/mL injection is the most-dispensed Phenylephrine product — about 73% of these Medicaid prescriptions.

1 ML phenylephrine hydrochloride 10 MG/ML Injection Most dispensed

12,865 Medicaid prescriptions (Q1–Q4 2025) 73% of Phenylephrine prescriptions shown $1.6M gross reimbursement (before rebates) ≈ $128 per prescription (gross)

Summed across the 17 of 80 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1666372

phenylephrine hydrochloride 10 MG/ML Injectable Solution

1,887 Medicaid prescriptions (Q1–Q4 2025) 11% of Phenylephrine prescriptions shown $453,596 gross reimbursement (before rebates) ≈ $240 per prescription (gross)

Summed across the 14 of 86 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1232651

phenylephrine hydrochloride 25 MG/ML Ophthalmic Solution

1,024 Medicaid prescriptions (Q1–Q4 2025) 6% of Phenylephrine prescriptions shown $43,621 gross reimbursement (before rebates) ≈ $43 per prescription (gross)

Summed across the 5 of 29 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1234579

5 ML phenylephrine hydrochloride 0.1 MG/ML Injection

564 Medicaid prescriptions (Q1–Q4 2025) 3% of Phenylephrine prescriptions shown $7,721 gross reimbursement (before rebates) ≈ $14 per prescription (gross)

Summed across the 3 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2262018

10 ML phenylephrine hydrochloride 0.1 MG/ML Injection

521 Medicaid prescriptions (Q1–Q4 2025) 3% of Phenylephrine prescriptions shown $7,780 gross reimbursement (before rebates) ≈ $15 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2634228

phenylephrine hydrochloride 100 MG/ML Ophthalmic Solution

353 Medicaid prescriptions (Q1–Q4 2025) 2% of Phenylephrine prescriptions shown $1,050 gross reimbursement (before rebates) ≈ $2.97 per prescription (gross)

Summed across the 1 of 14 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1234571

phenylephrine hydrochloride 10 MG Oral Tablet

349 Medicaid prescriptions (Q1–Q4 2025) 2% of Phenylephrine prescriptions shown $68,793 gross reimbursement (before rebates) ≈ $197 per prescription (gross)

Summed across the 3 of 196 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1049182

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Phenylephrine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 44 of 416 listed Phenylephrine NDCs with Medicaid activity.

Compare Phenylephrine products

A representative set of FDA-listed product records for Phenylephrine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 200 of 525 products — FDA National Drug Code Directory. See every product, package size and price: browse all 525 Phenylephrine NDCs →

Phenylephrine recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Phenylephrine recalls since July 2021.

✅No Phenylephrine recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Phenylephrine RxCUI 8163 11 dose forms · 25 strengths
  1. Dose form (SCDF) Chewable Tablet RxCUI 373368 No current FDA listing
    Clinical drug / strength (SCD) hydrochloride 10 MG RxCUI 1363777
  2. Dose form (SCDF) Injectable Solution RxCUI 373369 In current FDA listings
    Clinical drug / strength (SCD) hydrochloride 10 MG/ML RxCUI 1232651
  3. Dose form (SCDF) Nasal Solution RxCUI 373370 In current FDA listings
    Clinical drug / strength (SCD) hydrochloride 1.25 MG/ML RxCUI 1549386 hydrochloride 10 MG/ML RxCUI 1234563 hydrochloride 2.5 MG/ML RxCUI 1234586 hydrochloride 5 MG/ML RxCUI 1234581
  4. Dose form (SCDF) Ophthalmic Solution RxCUI 373372 In current FDA listings
    Clinical drug / strength (SCD) hydrochloride 1.2 MG/ML RxCUI 1547926 hydrochloride 100 MG/ML RxCUI 1234571 hydrochloride 25 MG/ML RxCUI 1234579 hydrochloride 50 MG/ML RxCUI 1548673 1.25 MG/ML RxCUI 562592
  5. Dose form (SCDF) Oral Film RxCUI 2269668 No current FDA listing
    Clinical drug / strength (SCD) hydrochloride 10 MG RxCUI 705164
  6. Dose form (SCDF) Oral Solution RxCUI 393309 In current FDA listings
    Clinical drug / strength (SCD) hydrochloride 0.5 MG/ML RxCUI 692479
  7. Dose form (SCDF) Oral Suspension RxCUI 373375 No current FDA listing
    Clinical drug / strength (SCD) tannate 1 MG/ML RxCUI 1366958
  8. Dose form (SCDF) Rectal Suppository RxCUI 376521 In current FDA listings
    Clinical drug / strength (SCD) hydrochloride 0.0025 MG/MG RxCUI 2715398 0.0025 MG/MG RxCUI 312398

Look up RxCUI 8163 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Phenylephrine brand names

Phenylephrine is sold under 16 brand names in the FDA directory — Children's Sudafed PE Nasal Decongestant, Lusonal, PediaCare Children's Decongestant, Sudafed PE Congestion and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Children's Sudafed PE Nasal Decongestant Lusonal PediaCare Children's Decongestant Sudafed PE Congestion Suphedrin PE Sudafed PE Wal-Four Wal-Phed PE Neo-Synephrine Rhinall Mydfrin Sudo-Tab Nasop Vazculep Little Noses Decongestant Biorphen

Who makes Phenylephrine: manufacturers and labelers

165 companies list Phenylephrine products with the FDA. By number of product records, the largest are Hikma Pharmaceuticals USA Inc., Lifestar Pharma LLC, Spirit Pharmaceuticals LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Hikma Pharmaceuticals USA Inc. 20 Lifestar Pharma LLC 17 Spirit Pharmaceuticals LLC 16 Medical Purchasing Solutions, LLC 12 CVS Pharmacy 11 Unifirst First Aid Corporation 10 L.N.K. International, Inc. 10 Provepharm Inc. 9 Walgreen Company 9 Caplin Steriles Limited 9 Amneal Pharmaceuticals LLC 9 Sandoz Inc 9 Amerisource Bergen 8 Kroger Company 8 Fresenius Kabi USA, LLC 8 H E B 8 A-S Medication Solutions 7 Bf Ascher And Co Inc 7 Somerset Therapeutics, LLC 7 Strategic Sourcing Services LLC 7 Allegiant Health 6 Accord Healthcare, Inc. 6 Civica, Inc. 6 Gland Pharma Limited 6

…and 141 more on the FDA NDC directory.

Phenylephrine drug class (RxNorm)

Phenylephrine belongs to the alpha-1 Adrenergic Agonist class.

Pharmacologic class alpha-1 Adrenergic Agonist
Drug family (ATC) Sympathomimetics excl. antiglaucoma preparations, Adrenergic and dopaminergic agents, Other agents for treatment of hemorrhoids and anal fissures for topical use
How it works Adrenergic alpha1-Agonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Phenylephrine page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective May 26, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Phenylephrine.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Phenylephrine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
55
Finished products in the current FDA directory
525
Companies listing them (makers, repackagers, distributors)
165
Linked representative label ⓘ
Cabinet Health P.B.C.
Linked label effective
May 26, 2026
Composite sections available
10
Linked SPL Set ID
4e75da23-35f2-431c-92cb-c2c4cb3f09f1
Linked SPL Document ID
52ba3bc2-5975-dab7-e063-6394a90a8350
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Cabinet Health P.B.C. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →