Home › NDC Lookup › Ingredients › Phenylephrine Hydrochloride › 42702-0103-05

Phenylephrine Hydrochloride 100 mg/mL Solution/ Drops

by Paragon BioTeck, Inc. · 1 BOTTLE, DROPPER in 1 CARTON (42702-103-05) / 5 mL in 1 BOTTLE, DROPPER

NDC 42702-0103-05

🏷️ FDA NDC (as labeled) 42702-103-05 billing pads the product segment with a zero

Rx only Brand On market Non-controlled

🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 42702-103-05

Product NDC 42702-103

11-digit billing NDC 42702010305

NCPDP billing unit ML — per mL (volume)

RxCUI 1234571, 1234579

UNII 04JA59TNSJ

Application # NDA203510

SPL Set ID a4d3fe20-f063-11e0-ac29-0002a5d5c51b

Established class (EPC) alpha-1 Adrenergic Agonist

Mechanism of action Adrenergic alpha1-Agonists

DEA schedule Non-controlled

Marketing category NDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2013-04-15

Route OPHTHALMIC

Dosage form SOLUTION/ DROPS

Substance PHENYLEPHRINE HYDROCHLORIDE

GPI-14 86350037102015

GPI class Phenylephrine HCl

GCN Seq No 007763

GCN 32282

HICL code 002087

Ingredient (HICL) Phenylephrine Hcl

HIC1 code Q

Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other

HIC2 code Q6

Therapeutic class — intermediate (HIC2) Ophthalmic Preparations

HIC3 code Q6C

Therapeutic class — specific (HIC3) Eye Vasoconstrictors

AHFS code 12:12.04.00

AHFS class Alpha-Adrenergic Agonists (12:12)

FDB label name PHENYLEPHRINE 10% EYE DROP

FDB brand name Phenylephrine Hcl

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AT · RLD · RS

Why two NDCs? The FDA registers this code as 42702-103-05 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 42702-0103-05. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine 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

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerParagon BioTeck, Inc.

Application holderPARAGON BIOTECK INC

FDA applicationNDA203510 (NDA)

Labeler code42702

First marketedApr 2013

Product typeHuman Prescription Drug

Portfolio2 products on file

🔎 All NDCs from Paragon BioTeck, Inc.

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name PHENYLEPHRINE 10% EYE DROP Ingredient Phenylephrine Hcl

📖 What it is MedlinePlus · NLM

Phenylephrine opthalmic is used to cause pupil dilation (making the black center of the eye bigger) before an eye examination. Phenylephrine is in a class of medications called mydriatics. It works by relaxing certain muscles in the eye.

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

Yes, it's the same active ingredient, but used in very different ways depending on the form. The nasal spray delivers a tiny amount directly to the nasal lining to temporarily shri...
I see phenylephrine in nasal sprays at the pharmacy AND as an IV drug in the hospital — is it really the same medication?
You should check with your doctor first. Phenylephrine constricts blood vessels, which can raise blood pressure and put extra strain on the heart — even from a nasal spray. If you...
Can I use the nasal spray if I have high blood pressure or heart disease?

📖 Read our full Phenylephrine guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Phenylephrine Hydrochloride — tap one for details:

Butcher's BroomModerate

🌿 Every supplement checked against Phenylephrine Hydrochloride (1 interactions) — ranked by severity →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII R57ZHV85D4
Boric acid is a weak acid derived from boron. In medicines, it typically serves as a buffer to help maintain the product's pH level and may act as a preservative in certain formulations.
UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
UNII GR686LBA74
Sodium phosphate, dibasic is a salt derived from phosphoric acid. It acts as a buffer to help maintain the medicine's pH balance and may serve as a binder or filler in tablets and capsules.
UNII 3980JIH2SW
A salt form of phosphoric acid that acts as a buffer and pH adjuster in medicines. It helps keep the product at the correct acidity level for stability and effectiveness.
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per mL	Per package
Retail pharmacies payNADAC · weekly	$5.132	$25.66 / 5 ml
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

NADAC price history (per mL) — tap or hover for the price & month

▼ Down 5% over the last 5 months.

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Phenylephrine Hydrochloride 100 mg/mL 00065-0343-02	Alcon	1 bottle	$5.131	AT	Availability likely	—
Phenylephrine Hydrochloride 100 mg/mLthis 42702-0103-05	Paragon	1 bottle	$5.131	AT	Availability likely	—
Phenylephrine Hydrochloride 100 mg/mL 65145-0150-01	Caplin	1 bottle	$5.131	AT	Availability likely	—
Phenylephrine Hydrochloride 100 mg/mL 69315-0324-05	Leading	1 bottle	$5.131	AT	Availability likely	—
Phenylephrine Hydrochloride 100 mg/mL 70512-0866-05	SOLA	1 bottle	$5.131	AT	Availability likely	—
Phenylephrine Hydrochloride 100 mg/mL 70756-0614-30	Lifestar	1 bottle	$5.131	AT	Availability likely	—
Phenylephrine Hydrochloride 100 mg/mL 72603-0530-01	NorthStar	1 bottle	$5.131	AT	Availability likely	—
Phenylephrine Hydrochloride 100 mg/mL 75907-0130-23	Dr.Reddy's	1 bottle	$5.131	AT	Availability likely	—
Phenylephrine Hydrochloride 25 mg/mL 82260-0103-05	Bausch	1 bottle	$5.131	AT	Availability likely	—
Phenylephrine Hydrochloride 100 mg/mL 68083-0594-01	Gland	1 bottle	—	AT	FDA listed	—
Phenylephrine Hydrochloride 100 mg/mL 81469-0169-05	First	1 bottle	—	AT	FDA listed	—

About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2013

First FDA approval

Mar 2013

📍

2026

Currently FDA-listed

13 years listed

🛡️

2033

Latest patent/protection listed

not a guaranteed launch date

✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Nov 2033. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.

📅 FDA approved Mar 21, 2013 AT TE-rated RLD RS ⏳ ~7.2 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book

US 8859623 — method of use (U-1594)

2013 2015 2017 2019 2021 2023 2025 2027 2029 2031 2033

Today

LOE

Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo

🏛️FDA exclusivity

FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.

🧪Product / substance patents

Patents covering the active ingredient, product, formulation, or related drug features.

🎯Method-of-use patents

Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.

🛈 What do these terms mean?

Patent: Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent: Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent: Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent: A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label: A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity: FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV: A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS: Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating: FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity): The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (2)

Patent	Type	Use code	Expires
US 8859623 ↗	Method of use	U-1594	Nov 14, 2033
US 8859623 ↗	Method of use	U-1594	Nov 14, 2033

Common questions

Is there a generic version of PHENYLEPHRINE 10% EYE DROP?

Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for PHENYLEPHRINE 10% EYE DROP. See the alternatives section for substitutable, lower-cost products.

The FDA approved a generic — why can’t I get it at my pharmacy yet?

FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.

Why do different websites show different generic release dates?

Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.

What does “FDA listed” mean?

It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.

What does a patent or protection date mean here?

It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).

What does “current Orange Book estimate” mean?

It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.

Can a generic come out before the last patent expires?

Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.

Can a generic come out after the listed dates?

Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.

What is the difference between patents and exclusivity?

Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.

Why are there multiple patent dates?

One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.

Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
42702-0103-05 You're viewing this	1 BOTTLE, DROPPER in 1 CARTON (42702-103-05) / 5 mL in 1 BOTTLE, DROPPER	2013-04-15	Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage 39 words ▾

1 INDICATIONS AND USAGE Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10% is indicated to dilate the pupil. Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10% is an alpha-1 adrenergic receptor agonist indicated to dilate the pupil (1 ).

⏱️ Dosage and Administration 194 words ▾

2 DOSAGE AND ADMINISTRATION For patients 1 year of age and older, apply one drop of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% or 10% at 3 to 5 minute intervals up to a maximum of 3 drops per eye ( 2.1 ). In pediatric patients less than 1 year of age, one drop of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% should be instilled at 3 to 5 minute intervals up to a maximum of 3 drops per eye ( 2.2 ).

2.1General Dosing Recommendations For patients 1 year of age or greater, apply one drop of either Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% or 10% every 3 to 5 minutes to the conjunctival fornix as required up to a maximum of 3 drops. If necessary, this dose may be repeated. In order to obtain a greater degree of mydriasis, Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% may be needed.

2.2Pediatric Patients Less Than 1 Year of Age In pediatric patients less than 1 year of age, one drop of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% should be instilled at 3 to 5 minute intervals up to a maximum of 3 drops per eye.

💊 Dosage Forms and Strengths 50 words ▾

3 DOSAGE FORMS AND STRENGTHS Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% is a clear, colorless, sterile topical ophthalmic solution containing phenylephrine hydrochloride 2.5%. Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% is a clear, colorless, sterile topical ophthalmic solution containing phenylephrine hydrochloride 10%. 2.5% and 10% sterile ophthalmic solutions ( 3 ).

⛔ Contraindications 155 words ▾

4 CONTRAINDICATIONS Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% is contraindicated in patients with hypertension, or thyrotoxicosis. Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% should be used in these patients ( 4.1 ). Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% is contraindicated in pediatric patients less than 1 year of age due to the increased risk of systemic toxicity.

Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% should be used in these patients ( 4.2 ).

4.1Cardiac and Endocrine Disease Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% is contraindicated in patients with hypertension, or thyrotoxicosis. Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% should be used in these patients.

4.2Pediatric Patients Less Than 1 Year of Age Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% is contraindicated in pediatric patients less than 1 year of age due to the increased risk of systemic toxicity. Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% should be used in these patients [See Dosage and Administration ( 2.2 )].

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Not for injection. Phenylephrine Hydrochloride Ophthalmic Solution, USP is indicated for topical ophthalmic use ( 5.1 ). Reports of serious cardiovascular reactions, some fatal, with Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% solution.

Monitor blood pressure in patients with cardiovascular disease ( 5.2 ). Significant elevations in blood pressure have been reported. Caution in pediatric patients less than 5 years of age, and in patients with elevated blood pressure ( 5.3 ).

Rebound miosis has been reported one day after instillation ( 5.4 ).

5.1Topical Ophthalmic Use Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10% is not indicated for injection.

5.2Cardiovascular Reactions There have been reports of serious cardiovascular reactions, including ventricular arrhythmias and myocardial infarctions, in patients using phenylephrine 10%. These episodes, some fatal, have usually occurred in patients with pre-existing cardiovascular diseases. Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% should be used in these patients.

5.3Elevation in Blood Pressure A significant elevation in blood pressure is not common but has been reported following conjunctival instillation of recommended doses of phenylephrine 10%. The risk is less with phenylephrine 2.5%. Caution should be exercised with the use of phenylephrine 10% in pediatric patients less than 5 years of age and patients with hyperthyroidism or cardiovascular disease.

The post-treatment blood pressure of patients with cardiac and endocrine diseases and any patients who develop symptoms should be carefully monitored.

5.4Rebound Miosis Rebound miosis has been reported one day after receiving phenylephrine ophthalmic solution, and re instillation of the drug produced a lesser mydriatic effect.

🤒 Adverse Reactions 219 words ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: Cardiac Disease [See Warnings and Precautions (5.2) ]. Elevation in Blood Pressure [See Warnings and Precautions (5.3) ]. The following adverse reactions have been identified following use of phenylephrine hydrochloride ophthalmic solution.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Ocular adverse reactions include eye pain and stinging on instillation, temporary blurred vision, and photophobia ( 6.1 ). Cardiovascular adverse reactions include increase in blood pressure, syncope, myocardial infarction, tachycardia, arrhythmia and subarachnoid hemorrhage ( 6.2 ).

To report SUSPECTED ADVERSE REACTIONS, contact Paragon BioTeck, Inc. at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Ocular Adverse Reactions Eye pain and stinging on instillation, temporary blurred vision and photophobia, and conjunctival sensitization may occur.

6.2Systemic Adverse Reactions A marked increase in blood pressure has been reported particularly, but not limited to, low weight premature neonates, infants and hypertensive patients. Cardiovascular reactions which have occurred primarily in hypertensive patients following topical ocular use of phenylephrine hydrochloride ophthalmic solution 10% include marked increase in blood pressure, syncope, myocardial infarction, tachycardia, arrhythmia and subarachnoid hemorrhage [See Warnings and Precautions (5.2 and 5.3) ].

🔄 Drug Interactions 67 words ▾

7 DRUG INTERACTIONS May exaggerate the adrenergic pressor response in patients taking atropine-like drugs ( 7.1 ). May potentiate the cardiovascular depressant effects of potent inhalation anesthetic agents ( 7.1 ).

7.1Agents That May Exaggerate Pressor Responses Concomitant use of phenylephrine and atropine may enhance the pressor effects and induce tachycardia in some patients. Phenylephrine may potentiate the cardiovascular depressant effects of some inhalation anesthetic agents.

👥 Use in Specific Populations 145 words ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Animal reproduction studies have not been conducted with topical phenylephrine. It is also not known whether phenylephrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10% should be given to a pregnant woman only if clearly needed.

8.3Nursing Mothers It is not known whether this drug is excreted in human breast milk. Because many drugs are excreted in human milk, caution should be exercised when Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10% is administered to a nursing woman.

8.4Pediatric Use Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% is contraindicated in pediatric patients less than 1 year of age. [See Contraindications (4.2) ] .

8.5Geriatric Use No overall differences in safety and effectiveness have been observed between elderly and younger adult patients.

🤰 Pregnancy 53 words ▾

🧒 Pediatric Use 25 words ▾

8.4Pediatric Use Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% is contraindicated in pediatric patients less than 1 year of age. [See Contraindications (4.2) ] .

🧓 Geriatric Use 19 words ▾

8.5Geriatric Use No overall differences in safety and effectiveness have been observed between elderly and younger adult patients.

🆘 Overdosage 40 words ▾

10 OVERDOSAGE Overdosage of phenylephrine may cause a rapid rise in blood pressure. It may also cause headache, anxiety, nausea, and vomiting and ventricular arrhythmias. Prompt injection of a rapidly acting alpha-adrenergic blocking agent such as phentolamine has been recommended.

🧬 Clinical Pharmacology 135 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Phenylephrine is an alpha-1 adrenergic receptor agonist used for dilation of the pupil due to its vasoconstrictor and mydriatic action. Phenylephrine possesses predominantly α-adrenergic effects. In the eye, phenylephrine acts locally as a potent vasoconstrictor and mydriatic, by constricting ophthalmic blood vessels and the radial muscle of the iris.

12.2Pharmacodynamics Maximal mydriasis occurs in 20-90 minutes with recovery after 3 to 8 hours. Systemic absorption of sufficient quantities of phenylephrine may lead to systemic α-adrenergic effects, such as rise in blood pressure which may be accompanied by a reflex atropine-sensitive bradycardia.

12.3Pharmacokinetics The systemic exposure following topical administration of phenylephrine hydrochloride ophthalmic solution has not been studied. A higher systemic absorption is expected for the 10% solution and when the corneal barrier function has been compromised.

🧬 Mechanism of Action 53 words ▾

📦 How Supplied / Storage and Handling 159 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% is supplied as a sterile, aqueous, topical ophthalmic solution with a fill volume of 10 mL in a 10 mL opaque, white low density polyethylene (LDPE) bottle with a linear low density polyethylene (LLDPE) dropper tip and red cap (NDC 42702-102-10), and a fill volume of 15mL in a 15mL opaque, white LDPE bottle with an LLDPE dropper tip and red cap (NDC 42702-102-15). Phenylephrine HCl Ophthalmic Solution, USP 10% is supplied as a sterile, aqueous, topical ophthalmic solution supplied with a fill volume of 5 mL in a 10 mL opaque, white LDPE bottle with an LLDPE dropper tip and red cap (NDC 42702-103-05).

Storage and Handling: Store at 2°C to 25°C (36°F to 77°F). Keep container tightly closed. Do not use if solution is brown or contains a precipitate.

After opening, Phenylephrine Hydrochloride Ophthalmic Solution, USP can be used until the expiration date on the bottle.

📦 Storage and Handling 43 words ▾

Storage and Handling: Store at 2°C to 25°C (36°F to 77°F). Keep container tightly closed. Do not use if solution is brown or contains a precipitate. After opening, Phenylephrine Hydrochloride Ophthalmic Solution, USP can be used until the expiration date on the bottle.

📋 Description 158 words ▾

11 DESCRIPTION Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10% is a sterile, clear, colorless, topical mydriatic agent for ophthalmic use. The chemical name is (R)-3-hydroxy-α-[(methylamino)methyl]benzenemethanol hydrochloride. Phenylephrine hydrochloride is represented by the following structural formula: Phenylephrine hydrochloride has a molecular weight of 203.67 and an empirical formula of C 9 H 13 NO 2 -HCl.

Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, 2.5% contains: ACTIVE: phenylephrine hydrochloride 25 mg (2.5%); INACTIVES: sodium phosphate monobasic, sodium phosphate dibasic; boric acid, water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH (4.0-7.5). The solution has a tonicity of 500 mOsm/kg; PRESERVATIVE: benzalkonium chloride 0.01%.

Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: phenylephrine hydrochloride 100 mg (10%); INACTIVES: sodium phosphate monobasic, sodium phosphate dibasic; water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH (4.0-7.5). The solution has a tonicity of 1000 mOsm/kg; PRESERVATIVE: benzalkonium chloride 0.01%. chem

💬 Information for Patients 61 words ▾

17 PATIENT COUNSELING INFORMATION Advise patients not to touch the dropper tip to any surface as this may contaminate the solution. Inform patients they may experience sensitivity to light and should protect their eyes in bright illumination while their pupils are dilated. Distributed by: Paragon BioTeck, Inc. Bridgewater, NJ 08807 USA © 2023 Bausch & Lomb Incorporated or its affiliates 9792900

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agonist: A substance that switches on a specific target in the body to produce an effect, the way a key turns a lock.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

anxiety: A feeling of worry, nervousness, or unease, sometimes along with a racing heart or restlessness.

arrhythmia: A heartbeat that is too fast, too slow, or irregular instead of steady.

bradycardia: A slower-than-normal heart rate, usually under 60 beats per minute.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

hemorrhage: Bleeding, especially heavy or uncontrolled bleeding, either inside the body or from an outside wound.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hyperthyroidism: A condition where the thyroid gland makes too much thyroid hormone, which can speed the body up.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inhalation: Breathed in through the mouth or nose so the medicine reaches the lungs or airways.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

mydriasis: Widening of the pupil, the dark center of the eye.

myocardial infarction: The medical term for a heart attack, when blood flow to part of the heart muscle is blocked.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

photophobia: Discomfort or pain in the eyes when exposed to light.

potentiate: To make the effect of one medicine stronger by taking another substance along with it.

rebound: The return of symptoms, sometimes worse than before, after a medicine that was controlling them is stopped.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

syncope: The medical term for fainting, a brief loss of consciousness from a temporary drop in blood flow to the brain.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

topical: Applied onto the skin, eyes, or another body surface to work mainly where it is placed.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

← 42702-0102-10 · Paragon 42708-0003-30 · QPharma, →

For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.

Phenylephrine Hydrochloride 100 mg/mL Solution/ Drops

🆔 Identity & classification

🏷️ RxNorm drug class

🏭 Manufacturer & labeler

🩺 Clinical

Patient education

Supplement & herbal interactions

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

📦 Packaging — all sizes for this product

📄 Full prescribing information FDA SPL

8 USE IN SPECIFIC POPULATIONS

12 CLINICAL PHARMACOLOGY

🔗 Related NDC lookups

💊 Related drugs in this class