NDC 81469-0168-15 — Phenylephrine Hydrochloride 25 mg/mL

🆔 Identity & classification

FDA NDC (as labeled) 81469-168-15

Product NDC 81469-168

11-digit billing NDC 81469016815

Application # ANDA216859

SPL Set ID 83a9cacf-e748-480b-a881-352f458abff7

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 2026-09-01

Route OPHTHALMIC

Dosage form SOLUTION/ DROPS

Substance PHENYLEPHRINE HYDROCHLORIDE

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

TE code (Orange Book) AT · RLD · RS

Why two NDCs? The FDA registers this code as 81469-168-15 — 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 → 81469-0168-15. 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.

🏭 Manufacturer & labeler

LabelerFirst Nation Group, LLC

Application holderMANKIND PHARMA LTD

FDA applicationANDA216859 (ANDA)

Labeler code81469

First marketedSep 2026

Product typeHuman Prescription Drug

Portfolio18 products on file

🔎 All NDCs from First Nation Group, LLC

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 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

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 F5UM2KM3W7
Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
UNII E4GA8884NN
Phosphoric acid is a weak mineral acid used in medicines as a buffer and pH adjuster. It helps stabilize the product and control its acidity level.
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 22ADO53M6F
A mineral salt derived from phosphoric acid, used as a buffer to maintain the pH balance of the medication and help stabilize the active ingredients.
UNII KH7I04HPUU
A salt compound made from sodium and phosphoric acid, used as a buffer to help maintain a stable pH level in the medicine, and sometimes as a binder or filler in tablets and capsules.
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	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.

Try another pack size: 2 mL

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 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	$9.201	AT	Availability likely	—
Phenylephrine Hydrochloride 25 mg/mL 69315-0323-08	Leading	1 bottle	$9.201	AT	Availability likely	—
Phenylephrine Hydrochloride 25 mg/mL 70512-0865-02	SOLA	1 bottle	$9.201	AT	Availability likely	—
Phenylephrine Hydrochloride 25 mg/mL 70756-0629-25	Lifestar	1 bottle	$9.201	AT	Availability likely	—
Phenylephrine Hydrochloride 25 mg/mL 72603-0520-01	NorthStar	1 bottle	$9.201	AT	Availability likely	—
Phenylephrine Hydrochloride 25 mg/mL 75907-0129-07	Dr.Reddy's	1 bottle	$9.201	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/mL 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/mLthis 81469-0168-15	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

🏛️

2026

On the market since

Sep 2026

📍

2026

Currently FDA-listed

listed with the FDA

🔓

·

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.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
81469-0168-02	1 BOTTLE, DROPPER in 1 CARTON (81469-168-02) / 2 mL in 1 BOTTLE, DROPPER	2026-09-01	Active
81469-0168-15 You're viewing this	1 BOTTLE, DROPPER in 1 CARTON (81469-168-15) / 15 mL in 1 BOTTLE, DROPPER	2026-09-01	Active

Pack size FAQ

What quantity is in NDC 81469-0168-15?

NDC 81469-0168-15 is listed by the FDA — 1 bottle, dropper in 1 carton / 15 ml in 1 bottle, dropper.

What NDC number is used to bill for this package of Phenylephrine Hydrochloride 25 mg/mL Solution/ Drops?

Bill NDC 81469-0168-15 — the 11-digit billing format is 81469016815. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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)	✓ 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 FDA registers it as 81469-168-15, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 81469-0168-15, written without dashes as 81469016815. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 81469-0168-15, the first segment (81469) is the labeler code FDA assigned to First Nation Group, LLC; the middle segment (0168) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (15) identifies this exact package size and type. Together they name one specific package of one specific product.

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 First Nation Group, LLC. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 1 other package presentation of this same product, including 1 bottle (81469-0168-02). Each has its own NDC and its own page — see the package list near the top of this page.

Who lists this product with the FDA?

First Nation Group, 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.

📄 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.

📄 FDA label

📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

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

🔗 Related NDC lookups

🧪 All Phenylephrine Hydrochloride NDCsSame ingredient 🏭 All First labeler NDCsLabeler code 81469 📚 All alpha-1 Adrenergic Agonist NDCsDrug class

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Eye Vasoconstrictors.

Oxymetazoline Hcl/Pf 73687-0062-32

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.