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.
🧬 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 →
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.
Patient information guide — a plain-language walkthrough of Phenylephrine, written from its FDA label.
What Phenylephrine is used for
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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
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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
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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
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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
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- 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
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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
▾
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 →
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.
- Major · 6
- Moderate · 60
- Minor · 15
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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Can I take it with my antidepressant?
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What side effects should I expect?
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When should I stop using the over-the-counter products?
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Do I need to check anything first if I have a health condition?
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Is it safe in pregnancy?
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Is Phenylephrine available over the counter?
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When was Phenylephrine first available?
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Who makes Phenylephrine?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Phenylephrine on HelloPharmacist
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
Injection
How this form is used
- 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.
- 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.
Nasal spray
How this form is used
- 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.
Eye drops
How this form is used
- Phenylephrine Hydrochloride Ophthalmic Solution 2.5% and 10% is used to dilate the pupil.
- 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.
Rectal suppository
How this form is used
- 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.
- 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.
Oral solution
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.
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.
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.
How commonly is Phenylephrine prescribed? Of the 1,601 medications we measure, Phenylephrine ranks #822 by Medicaid prescriptions — more than 49% of them.
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.
1 ML phenylephrine hydrochloride 10 MG/ML Injection Most dispensed
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
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
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
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
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
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
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.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 10 mg/mL | Intravenous | Accord Healthcare, Inc. × 6 listings | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Amneal Pharmaceuticals LLC × 9 listings | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Apollo Pharmaceuticals Inc. × 3 listings | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Armas Pharmaceuticals Inc. | ANDA | View NDC → |
| 50 mg/5 mL | Intravenous | Armas Pharmaceuticals Inc. | ANDA | View NDC → |
| 100 mg/10 mL | Intravenous | Armas Pharmaceuticals Inc. | ANDA | View NDC → |
| 10 mg/mL | Intravenous | AuroMedics Pharma LLC × 3 listings | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Avadel Legacy Pharmaceuticals, LLC | NDA | View NDC → |
| 10 mg/mL | Intravenous | Baxter Healthcare Corporation × 3 listings | ANDA | View NDC → |
| 10 mg/mL | Intravenous | BE Pharmaceuticals Inc. × 3 listings | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Camber Pharmaceuticals, Inc. × 3 listings | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Caplin Steriles Limited × 2 listings | ANDA | View NDC → |
| 50 mg/5 mL | Intravenous | Caplin Steriles Limited × 2 listings | ANDA | View NDC → |
| 100 mg/10 mL | Intravenous | Caplin Steriles Limited × 2 listings | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Cardinal Health | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Cardinal Health 107, LLC × 3 listings | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Civica, Inc. × 6 listings | NDA | View NDC → |
| 0.1 mg/mL | Intravenous | Dr. Reddy's Laboratories Inc. × 2 listings | NDA | View NDC → |
| 10 mg/mL | Intravenous | Dr. Reddy's Laboratories Inc. × 2 listings | NDA | View NDC → |
| 0.1 mg/mL | Intravenous | Eton Pharmaceuticals, Inc. × 2 listings | NDA | View NDC → |
| 10 mg/mL | Intravenous | Eugia US LLC × 3 listings | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Exela Phrama Sciences, LLC × 3 listings | NDA | View NDC → |
| 10 mg/mL | Intravenous | Fresenius Kabi USA, LLC × 8 listings | ANDA | View NDC → |
| 10 mg/mL | Intravenous | General Injectables and Vaccines, Inc. | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Gland Pharma Limited × 3 listings | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Hainan Poly Pharm. Co., Ltd. × 3 listings | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Henry Schein, Inc. × 3 listings | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. × 2 listings | ANDA | View NDC → |
| 10 mg/mL | Intravenous | HF Acquisition Co LLC, DBA HealthFirst × 2 listings | ANDA | View NDC → |
| 10 mg/mL | Intravenous | HF Acquisition Co LLC, DBA HealthFirst × 3 listings | NDA | View NDC → |
| 100 mcg/mL | Intravenous | Hikma Pharmaceuticals USA Inc. × 6 listings | NDA | View NDC → |
| 10 mg/mL | Intravenous | Hikma Pharmaceuticals USA Inc. × 14 listings | NDA | View NDC → |
| 10 mg/mL | Intravenous | Lifestar Pharma LLC × 2 listings | ANDA | View NDC → |
| 50 mg/5 mL | Intravenous | Lifestar Pharma LLC × 2 listings | ANDA | View NDC → |
| 100 mg/10 mL | Intravenous | Lifestar Pharma LLC × 2 listings | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Medical Purchasing Solutions, LLC × 3 listings | NDA | View NDC → |
| 10 mg/mL | Intravenous | Medical Purchasing Solutions, LLC × 9 listings | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Medical Purchasing Solutions, LLC. | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Medical Purhasing Solutions, LLC | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Meitheal Pharmaceuticals Inc. × 3 listings | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Method Pharmaceuticals, LLC × 3 listings | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Novadoz Pharmaceuticals LLC × 3 listings | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Par Health USA, LLC × 2 listings | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Par Pharmaceutical, Inc. × 2 listings | ANDA | View NDC → |
| 10 mg/mL | Intravenous | ProPharma Distribution | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Provepharm Inc. × 9 listings | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Sagent Pharmaceuticals | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Sandoz Inc × 9 listings | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Somerset Therapeutics, LLC × 2 listings | ANDA | View NDC → |
| 50 mg/5 mL | Intravenous | Somerset Therapeutics, LLC × 2 listings | ANDA | View NDC → |
| 100 mg/10 mL | Intravenous | Somerset Therapeutics, LLC × 2 listings | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Xellia Pharmaceuticals USA LLC | ANDA | View NDC → |
| 50 mg/5 mL | Intravenous | Xellia Pharmaceuticals USA LLC | ANDA | View NDC → |
| 100 mg/10 mL | Intravenous | Xellia Pharmaceuticals USA LLC | ANDA | View NDC → |
| 💊Nasal spray | ||||
| 1.25 mg/mL | Nasal | Medtech Products Inc. × 2 listings | OTC MONOGRAPH FINAL | View NDC → |
| 💊Oral solution | ||||
| 2.5 mg/15 mL | Oral | GM Pharmaceuticals, INC | OTC MONOGRAPH FINAL | View NDC → |
| 2.5 mg/15 mL | Oral | GM Pharmaceuticals, INC | OTC MONOGRAPH DRUG | View NDC → |
| 2.5 mg/5 mL | Oral | Johnson & Johnson Consumer Inc. | OTC MONOGRAPH FINAL | View NDC → |
| 2.5 mg/5 mL | Oral | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | OTC MONOGRAPH FINAL | View NDC → |
| 2.5 mg/5 mL | Oral | Kenvue Brands LLC | OTC MONOGRAPH DRUG | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | AX Pharmaceutical Corp | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING | View NDC → |
| 1 kg/kg | — | Boehringer Ingelheim Pharma GmbH and Co. KG | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Cheng Fong Chemical Co., Ltd. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Divi's Laboratories Limited × 2 listings | BULK INGREDIENT | View NDC → |
| 1 g/g | — | Fagron Inc | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING | View NDC → |
| 1 g/g | — | Letco Medical, Llc | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING | View NDC → |
| 1 kg/kg | — | Malladi Drugs & Pharmaceuticals Limited × 3 listings | BULK INGREDIENT | View NDC → |
| 1 g/g | — | Medisca Inc. × 2 listings | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Professional Compounding Centers of America dba PCCA × 2 listings | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING | View NDC → |
| 1 kg/kg | — | Shenzhen Oriental Pharmaceutical Co., Ltd. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Shenzhen Oriental Pharmaceutical Co. Ltd. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Shilpa Pharma Lifesciences Limited | BULK INGREDIENT | View NDC → |
| 1 g/g | — | Spectrum Laboratory Products, Inc. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Spera Nexus, Inc. × 2 listings | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Syn-Tech Chem. & Pharm. Co., Ltd. | BULK INGREDIENT | View NDC → |
| 22.2 g/kg | — | Trillium Health Care Products Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 1 g/g | — | Willow Birch Pharma, Inc. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Zhejiang Hisoar Chuannan Pharmaceutical Co., Ltd. | BULK INGREDIENT | View NDC → |
Showing 200 of 525 products — FDA National Drug Code Directory. See every product, package size and price: browse all 525 Phenylephrine NDCs →
Phenylephrine side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Phenylephrine — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Phenylephrine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Phenylephrine FDA approval history
How Phenylephrine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
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 2021Source: 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.
RxCUI 8163 11 dose forms · 25 strengths
-
Dose form (SCDF) Chewable Tablet RxCUI 373368No current FDA listingClinical drug / strength (SCD) hydrochloride 10 MGRxCUI 1363777 -
Dose form (SCDF) Injectable Solution RxCUI 373369In current FDA listingsClinical drug / strength (SCD) hydrochloride 10 MG/MLRxCUI 1232651 -
Dose form (SCDF) Injection RxCUI 1666371In current FDA listingsClinical drug / strength (SCD) 1 ML phenylephrine hydrochloride 10 MG/MLRxCUI 16663725 ML phenylephrine hydrochloride 0.1 MG/MLRxCUI 226201810 ML phenylephrine hydrochloride 0.1 MG/MLRxCUI 2634228250 ML phenylephrine hydrochloride 0.08 MG/MLRxCUI 2717659 -
Dose form (SCDF) Nasal Solution RxCUI 373370In current FDA listingsClinical drug / strength (SCD) hydrochloride 1.25 MG/MLRxCUI 1549386hydrochloride 10 MG/MLRxCUI 1234563hydrochloride 2.5 MG/MLRxCUI 1234586hydrochloride 5 MG/MLRxCUI 1234581 -
Dose form (SCDF) Nasal Spray RxCUI 374570In current FDA listingsClinical drug / strength (SCD) hydrochloride 10 MG/MLRxCUI 1087043hydrochloride 2.5 MG/MLRxCUI 1234576hydrochloride 5 MG/MLRxCUI 1234584 -
Dose form (SCDF) Ophthalmic Solution RxCUI 373372In current FDA listingsClinical drug / strength (SCD) hydrochloride 1.2 MG/MLRxCUI 1547926hydrochloride 100 MG/MLRxCUI 1234571hydrochloride 25 MG/MLRxCUI 1234579hydrochloride 50 MG/MLRxCUI 15486731.25 MG/MLRxCUI 562592 -
Dose form (SCDF) Oral Film RxCUI 2269668No current FDA listingClinical drug / strength (SCD) hydrochloride 10 MGRxCUI 705164 -
Dose form (SCDF) Oral Solution RxCUI 393309In current FDA listingsClinical drug / strength (SCD) hydrochloride 0.5 MG/MLRxCUI 692479 -
Dose form (SCDF) Oral Suspension RxCUI 373375No current FDA listingClinical drug / strength (SCD) tannate 1 MG/MLRxCUI 1366958 -
Dose form (SCDF) Oral Tablet RxCUI 379042In current FDA listings -
Dose form (SCDF) Rectal Suppository RxCUI 376521In current FDA listings
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 supply and shortage status
Whether Phenylephrine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
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.
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.
…and 141 more on the FDA NDC directory.
Phenylephrine drug class (RxNorm)
Phenylephrine belongs to the alpha-1 Adrenergic Agonist class.
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.
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 →