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 81469-168-02 (Billing 81469-0168-02)
by First Nation Group, LLC · 1 BOTTLE, DROPPER in 1 CARTON / 2 mL in 1 BOTTLE, DROPPER
This is a package of Phenylephrine Hydrochloride 25 mg/mL Solution/ Drops from First Nation Group, LLC, marketed since Sep 2026 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.
NDC 81469-0168-02
🏷️ FDA NDC (as labeled)
81469-168-02
billing pads the product segment with a zero
This package
Contains2 mL in 1 bottle, dropper
Pack sizes2 compare ↓
Main listing for product 81469-168 · Also comes in:
15 mL 81469-168-15
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
NDC database record
One package, one record: these facts belong to NDC 81469-168-02 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 81469 labeler · 168 product · 02 package
- Package marketed since
- Sep 1, 2026
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 8146916802 0
- FDA record last changed
- Oct 8, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
81469-168-02
Product NDC
81469-168
11-digit billing NDC
81469016802
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
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
Why two NDCs?
The FDA registers this code as 81469-168-02 — 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 → 81469-0168-02. 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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
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...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Phenylephrine Hydrochloride — tap one for details:
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.
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
💬 Questions about Phenylephrine Hydrochloride?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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:
15 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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 8, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 81469-0168-02 You're viewing this Main listing | 1 BOTTLE, DROPPER in 1 CARTON / 2 mL in 1 BOTTLE, DROPPER | 2026-09-01 | — | Active |
| 81469-0168-15 81469-168-15 | 1 BOTTLE, DROPPER in 1 CARTON / 15 mL in 1 BOTTLE, DROPPER | 2026-09-01 | — | Active |
Pack size FAQ
What quantity is in this package?
This package is listed by the FDA — 1 bottle, dropper in 1 carton / 2 ml in 1 bottle, dropper.
What NDC number is used to bill for this package of Phenylephrine Hydrochloride 25 mg/mL Solution/ Drops?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
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 | $9.292 | 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/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 81469-0168-02 | 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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
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.
- FDA Orange Book · refreshed Oct 3, 2026
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.
💡 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.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
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
LabelerFirst Nation Group, LLC
Application holderMANKIND PHARMA LTD
FDA applicationANDA216859 (ANDA)
Labeler code81469
First marketedSep 2026
Product typeHuman Prescription Drug
Portfolio19 products on file
More NDCs from First Nation Group, LLC labeler code 81469
- Midodrine Hydrochloride 2.5 mg Tablet NDC 81469-139-90
- Midodrine Hydrochloride 5 mg Tablet NDC 81469-140-90
- Midodrine Hydrochloride 10 mg Tablet NDC 81469-141-90
- Phenylephrine Hydrochloride 100 mg/mL Solution/ Drops NDC 81469-169-05
- timolol maleate 2.5 mg/mL Solution/ Drops NDC 81469-209-05
- timolol maleate 5 mg/mL Solution/ Drops NDC 81469-210-05
- Bumetanide .5 mg Tablet NDC 81469-221-01
- Bumetanide 1 mg Tablet NDC 81469-222-01
- Bumetanide 2 mg Tablet NDC 81469-223-01
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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
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 ▾
No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.
No label section mentions that — try another word, or open the full label on DailyMed below.
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
Age at onset
Reporter sex
Male · 31%
Female · 69%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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) | ✓ 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 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 (81469-0168-15). 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.
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.