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Phenylephrine Hydrochloride 25 mg/mL Solution/ Drops — NDC 70756-0676-30 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Phenylephrine Hydrochloride 25 mg/mL Solution/ Drops — NDC 70756-676-30 (Billing 70756-0676-30)

by Lifestar Pharma LLC · 1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER

This is a package of Phenylephrine Hydrochloride 25 mg/mL Solution/ Drops from Lifestar Pharma LLC, marketed since Aug 2025 and currently FDA-listed. It is this product's only package size.

NDC 70756-0676-30
🏷️ FDA NDC (as labeled) 70756-676-30 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 13, 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

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

NDC database record

One package, one record: these facts belong to NDC 70756-676-30 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
70756 labeler · 676 product · 30 package
Package marketed since
Aug 26, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0370756676300, 0370756629252
FDA record last changed
Aug 13, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70756-676-30
Product NDC 70756-676
11-digit billing NDC 70756067630
NCPDP billing unit ML — per mL (volume)
RxCUI 1234579
UNII 04JA59TNSJ
UPC 0370756676300, 0370756629252
Application # ANDA216859
SPL Set ID f43e4abd-0083-4fe5-9c27-0ba9245e5138
Established class (EPC) alpha-1 Adrenergic Agonist
Mechanism of action Adrenergic alpha1-Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-08-26
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance PHENYLEPHRINE HYDROCHLORIDE
TE code (Orange Book) AT · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 007764
GCN 32283
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 2.5% EYE DROP
FDB brand name Phenylephrine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 007764
  • GCN: 32283
  • HICL (First Databank): 002087
  • AHFS class code: 12:12.04.00
  • RxCUI (RxNorm): 1234579
Why two NDCs? The FDA registers this code as 70756-676-30 — 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 → 70756-0676-30. 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.

Clinical

Label name PHENYLEPHRINE 2.5% 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
  • 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 conges...
  • 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 m...
  • 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...
  • 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 recomm...
📖 Read our full Phenylephrine guide →

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.

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 systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70756-0676-30 You're viewing this Main listing 1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER 2025-08-26 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Phenylephrine Hydrochloride 25 mg/mL 82260-0103-05 Bausch 1 bottle $5.131 AT Availability likely —
Phenylephrine Hydrochloride 25 mg/mL 65145-0148-01 Caplin 1 bottle $9.292 AT Availability likely —
Phenylephrine Hydrochloride 25 mg/mL 69315-0323-08 Leading 1 bottle $9.292 AT Availability likely —
Phenylephrine Hydrochloride 25 mg/mL 70512-0865-02 SOLA 1 bottle $9.292 AT Availability likely —
Phenylephrine Hydrochloride 25 mg/mL 70756-0629-25 Lifestar 1 bottle $9.292 AT Availability likely —
Phenylephrine Hydrochloride 25 mg/mL 72603-0520-01 NorthStar 1 bottle $9.292 AT Availability likely —
Phenylephrine Hydrochloride 25 mg/mL 75907-0129-07 Dr.Reddy's 1 bottle $9.292 AT Availability likely —
Phenylephrine Hydrochloride 25 mg/mL 00065-0349-04 Alcon 1 bottle — AT FDA listed —
Phenylephrine Hydrochloride 25 mg/mL 42702-0102-10 Paragon 1 bottle — AT FDA listed —
Phenylephrine Hydrochloride 25 mg/mL 65145-0149-01 Caplin 1 bottle — AT FDA listed —
Phenylephrine Hydrochloride 25 mg/mL 68083-0593-01 Gland 1 bottle — AT FDA listed —
Phenylephrine Hydrochloride 25 mg/mL 68083-0680-01 Gland 1 bottle — AT FDA listed —
Phenylephrine Hydrochloride 25 mg/mL 70756-0649-35 Lifestar 1 bottle — AT FDA listed —
Phenylephrine Hydrochloride 25 mg/mLthis 70756-0676-30 Lifestar 1 bottle — AT FDA listed —
Phenylephrine Hydrochloride 25 mg/mL 75907-0324-22 Dr.Reddy's 1 bottle — AT FDA listed —
Phenylephrine Hydrochloride 25 mg/mL 81469-0168-02 First 1 bottle — AT FDA listed —
Phenylephrine Hydrochloride 25 mg/mL 82260-0102-10 Bausch 1 bottle — AT FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2025
On the market since
Aug 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

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.

🧪 Avoiding an ingredient? See Phenylephrine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.

Manufacturer & labeler

LabelerLifestar Pharma LLC
Application holderMANKIND PHARMA LTD
FDA applicationANDA216859 (ANDA)
Labeler code70756
First marketedAug 2025
Product typeHuman Prescription Drug
Portfolio155 products on file

More NDCs from Lifestar Pharma LLC labeler code 70756

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.

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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🔬 Clinical Studies 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 35 words ▾

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

⏱️ Dosage and Administration 201 words ▾

2 DOSAGE AND ADMINISTRATION For patients 1 year of age and older : ( 2.1 ) Apply one drop of Phenylephrine Hydrochloride Ophthalmic Solution (2.5% and 10% strength) to conjunctival fornix at 3 to 5 minute intervals up to a maximum of 3 drops per eye. To obtain a greater degree of mydriasis, use 10% strength For pediatric patients less than 1 year of age : ( 2.2 ) Instill one drop of 2.5% strength to conjunctival fornix at 3 to 5 minute intervals up to a maximum of 3 drops per eye

2.1General Dosing Recommendations In patients 1 year of age or greater, apply one drop of phenylephrine hydrochloride ophthalmic solution 2.5% or 10% every 3 to 5 minutes to the conjunctival fornix as required up to a maximum of 3 drops per eye per day. In order to obtain a greater degree of mydriasis, phenylephrine hydrochloride ophthalmic solution 10% may be needed.

2.2Dosing in Pediatric Patients Less Than 1 Year of Age In pediatric patients less than 1 year of age, one drop of phenylephrine hydrochloride ophthalmic solution 2.5% should be instilled at 3 to 5 minute intervals up to a maximum of 3 drops per eye.

💊 Dosage Forms and Strengths 93 words ▾

3 DOSAGE FORMS AND STRENGTHS Phenylephrine hydrochloride ophthalmic solution, USP 2.5% is a clear, colorless to yellow colored sterile topical ophthalmic solution containing phenylephrine hydrochloride 2.5%.: each mL contains 25 mg of phenylephrine hydrochloride, USP. Phenylephrine hydrochloride ophthalmic solution, USP 10% is a clear, colorless, to yellow colored sterile topical ophthalmic solution containing phenylephrine hydrochloride 10%.: each mL contains 100 mg of phenylephrine hydrochloride, USP. Ophthalmic solution (sterile): ( 3 ) 25 mg of phenylephrine hydrochloride in one mL of solution (2.5%) 100 mg of phenylephrine hydrochloride in one mL of solution (10%)

⛔ Contraindications 115 words ▾

4 CONTRAINDICATIONS The 10% strength is contraindicated in: Patients with hypertension, or thyrotoxicosis ( 4.1 ) Pediatric patients less than 1 year of age due to increased risk of systemic toxicity ( 4.2 )

4.1Cardiac and Endocrine Disease Phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in patients with hypertension or thyrotoxicosis. Phenylephrine hydrochloride ophthalmic solution 2.5% should be used in these patients.

4.2Pediatric Patients Less Than 1 Year of Age Phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in pediatric patients less than 1 year of age due to the increased risk of systemic toxicity. Phenylephrine hydrochloride ophthalmic solution 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 : Topical ophthalmic use only ( 5.1 ) Serious cardiovascular reactions with 10% strength : Reactions have included ventricular arrhythmias and some have been fatal. Monitor blood pressure in patients with cardiovascular disease ( 5.2 ). Significant elevations in blood pressure : Caution in pediatric patients less than 5 years of age, and in patients with cardiovascular disease or hyperthyroidism.

In patients at high risk, monitor blood pressure post treatment ( 5.3 ). Rebound miosis : Reported one day after instillation ( 5.4 )

5.1Topical Ophthalmic Use Only Phenylephrine hydrochloride ophthalmic solution 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 2.5% should be used in these patients.

5.3Elevation of 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 hydrochloride ophthalmic solution, and re-instillation of the drug produced a lesser mydriatic effect.

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: Cardiovascular Effects [ 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.

To report SUSPECTED ADVERSE REACTIONS, contact Lifestar Pharma LLC at 1-888-995-4337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 )

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 effects which have been seen 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 64 words ▾

7 DRUG INTERACTIONS Atropine-like drugs : May exaggerate the adrenergic pressor response ( 7.1 ) Potent inhalation anesthetic agents : May potentiate cardiovascular depressant effects ( 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 139 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 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 2.5% and 10% is administered to a nursing woman.

8.4Pediatric Use Phenylephrine hydrochloride ophthalmic solution 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.

🆘 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 141 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Phenylephrine hydrochloride is an α-1 adrenergic agonist drug that is used in ophthalmology mainly for its mydriatic effect. After topical application to the conjunctiva, phenylephrine acts directly on α-adrenergic receptors in the eye, producing contraction of the dilator muscle of the pupil and constriction of the arterioles in the conjunctiva.

12.2Pharmacodynamics Maximal mydriasis occurs in 20 to 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 than the 2.5% solution and when the corneal barrier function is compromised.

📦 How Supplied / Storage and Handling 172 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Phenylephrine hydrochloride ophthalmic solution, USP 2.5% is supplied as a clear, colorless to yellow colored sterile, aqueous, topical ophthalmic solution in an opaque, white low density polyethylene (LDPE) bottle with a natural LDPE dropper tip and red cap in the following sizes: NDC 70756-629-25 2 mL in 5 mL bottle NDC 70756-676-30 10 mL in 10 mL bottle NDC 70756-649-35 15 mL in 15 mL bottle Phenylephrine hydrochloride ophthalmic solution, USP 10% is supplied as a sterile, clear, colorless to yellow color, aqueous, topical ophthalmic solution in an opaque, white low density polyethylene (LDPE) bottle with a natural LDPE dropper tip and red cap in the following sizes: NDC 70756-614-30 5 mL in 10 mL bottle After opening, Phenylephrine Hydrochloride Ophthalmic Solution, USP can be use until the expiration date on the bottle.

Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Keep container tightly closed. Protect from light and excessive heat.

Do not use if solution is brown or contains precipitate.

📋 Description 161 words ▾

11 DESCRIPTION Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless to yellow color solution, topical α -adrenergic agonist for ophthalmic use. The active ingredient is represented by the chemical structure: Chemical Name: (R)-3-hydroxy-α[(methylamino)methyl]benzenemethanol hydrochloride. Molecular Formula : C 9 H 13 NO 2.

HCl Molecular Weight: 203.67 g/mol Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% contains: ACTIVE: Phenylephrine Hydrochloride, USP 25 mg (2.5%); INACTIVES : Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 340 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (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. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 985 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%). structure

💬 Information for Patients 81 words ▾

17 PATIENT COUNSELING INFORMATION Advise patients not to touch the dropper tip to any surface as this may contaminate the solution. Inform patients that they may experience sensitivity to light and should protect their eyes in bright illumination while their pupils are dilated. Manufactured for: Lifestar Pharma LLC 1200 MacArthur Blvd.

Mahwah, NJ 07430 USA Made in India Revised: July 2025, V-05 Manufactured for: Lifestar Pharma LLC 1200 MacArthur Blvd. Mahwah, NJ 07430 USA Product of Taiwan Revised: April 2026, V-01

🔬 Clinical Studies 62 words ▾

14 CLINICAL STUDIES Pupillary dilation following topical administration of phenylephrine hydrochloride ophthalmic solution has been demonstrated in controlled clinical studies in adults and pediatric patients with different levels of iris pigmentation. Pupil movement is generally seen within 15 minutes, maximal mydriasis between 20 to 90 minutes and recovery after 3 to 8 hours. Darker irides tend to dilate slower than lighter irides.

📄 Package Label / Principal Display Panel ~1 min read ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Made in India NDC 70756-629-25 Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% For Topical Application in the Eye. Not for Injection 2 mL Rx only NDC 70756-629-25 Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% For Topical Application in the Eye. Not for Injection 2 mL Rx only NDC 70756-649-35 Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% For Topical Application in the Eye.

Not for Injection 15 mL Rx only NDC 70756-649-35 Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% For Topical Application in the Eye. Not for Injection 15 mL Rx only NDC 70756-676-30 Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% For Topical Application in the Eye. Not for Injection 10 mL Rx only NDC 70756-676-30 Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% For Topical Application in the Eye.

Not for Injection 10 mL Rx only Product of Taiwan NDC 70756-629-25 Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% For Topical Application in the Eye. Not for Injection 2 mL Rx only NDC 70756-629-25 Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% For Topical Application in the Eye. Not for Injection 2 mL Rx only NDC 70756-649-35 Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% For Topical Application in the Eye.

Not for Injection 15 mL Rx only NDC 70756-649-35 Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% For Topical Application in the Eye. Not for Injection 15 mL Rx only 2ml label 2ml carton 15mlbottle 15mLcarton 10 ml-Label 10ml-carton 2ml-label-taiwan 2ml-carton-taiwan 15ml-label-taiwan 15ml-carton-taiwan

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

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for PHENYLEPHRINE HYDROCHLORIDE — the ingredient across all brands.

Top reported reactions

Fatigue17,479
Headache14,275
Pain14,233
Nausea14,023
Diarrhoea11,944
Arthralgia11,112
Dyspnoea10,803

Age at onset

Neonate113
Infant504
Child1,107
Adolescent638
Adult16,345
Elderly12,489

Reporter sex

168,585 reports
Male · 31%
Female · 69%
Unknown · 0%

Serious outcomes

Hospitalization43,935
Death13,703
Disabling6,802
Life-threatening6,546
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 15,951 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Lifestar Pharma LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Lifestar Pharma LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 70756-0670-10 · Lifestar 70756-0677-00 · Lifestar →
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.