Ketotifen Fumarate Ophthalmic Solution .25 mg/mL Solution/ Drops
by Preferred Pharmaceuticals Inc. · 1 BOTTLE, DROPPER in 1 CARTON (68788-4084-5) / 5 mL in 1 BOTTLE, DROPPER
NDC 68788-4084-05
🏷️ FDA NDC (as labeled)
68788-4084-5
billing pads the package segment with a zero
OTC
Generic
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 →
🆔 Identity & classification
FDA NDC (as labeled)
68788-4084-5
Product NDC
68788-4084
11-digit billing NDC
68788408405
NCPDP billing unit
ML — per mL (volume)
RxCUI
311237
UNII
HBD503WORO
Application #
ANDA077958
SPL Set ID
f4dd2b53-c2f2-4c5a-8eb0-c96d79cf419c
Established class (EPC)
Histamine-1 Receptor Inhibitor
Mechanism of action
Histamine H1 Receptor Antagonists
DEA schedule
Non-controlled
Marketing category
ANDA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2026-02-27
Route
OPHTHALMIC
Dosage form
SOLUTION/ DROPS
Substance
KETOTIFEN FUMARATE
Why two NDCs?
The FDA registers this code as 68788-4084-5 — a 5-4-1 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 package segment → 68788-4084-05. 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 Histamine-1 Receptor Inhibitor class.
Pharmacologic class
Histamine-1 Receptor Inhibitor
Drug family (ATC)
Other antihistamines for systemic use, Other antiallergics
How it works
Histamine H1 Receptor Antagonists
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
LabelerPreferred Pharmaceuticals Inc.
Application holderSENTISS AG
FDA applicationANDA077958 (ANDA)
Labeler code68788
First marketedFeb 2026
Product typeHuman Otc Drug
Portfolio825 products on file
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
📖 What it is MedlinePlus · NLM
Ophthalmic ketotifen is used to relieve the itching of allergic pinkeye. Ketotifen is in a class of medications called antihistamines. It works by blocking histamine, a substance in the body that causes allergic symptoms.
Read the full MedlinePlus article ↗📗 Our plain-language guide HelloPharmacist
- Ketotifen blocks the histamine receptors in your eye that cause itching when you're exposed to allergens like pollen, pet dander, or grass. It also calms down the immune cells that...
- What exactly does ketotifen do for my eyes?
- You use ketotifen eye drops twice a day, about every 8 to 12 hours — no more than two times daily. Always remove your contact lenses before putting in the drops, and wait at least...
- How often do I use the eye drops, and can I use them with contacts in?
Patient education
Supplement & herbal interactions
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.
💬 Questions about Ketotifen Fumarate?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
-
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 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.
5 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesBenzalkonium Chloride 0.01%; Glycerin and Water for Injection. May contain Hydrochloric Acid and/or Sodium Hydroxide (to adjust pH).
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
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.
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 |
|---|---|---|---|---|---|---|
| Ketotifen Fumarate .25 mg/mL 00536-1252-40 | Rugby | 1 bottle | $1.304 | — | Availability likely | — |
| Eye Itch Relief .25 mg/mL 70000-0522-01 | Cardinal | 1 bottle | $1.304 | — | Availability likely | — |
| Ketotifen Fumarate Ophthalmic Solution .25 mg/mL 70244-0041-01 | Sentiss | 1 bottle | $1.304 | — | Availability likely | — |
| Ketotifen Fumarate Ophthalmic Solution .25 mg/mL 72485-0617-10 | Armas | 1 bottle | $1.304 | — | Availability likely | — |
| Ketotifen Fumarate .25 mg/mL 76385-0106-17 | Unichem | 1 bottle | $1.304 | — | Availability likely | — |
| Eye Itch Relief .35 mg/mL 70000-0124-01 | CARDINAL | 1 bottle | $1.322 | — | FDA listed | — |
| Alaway .25 mg/mL 24208-0601-05 | Bausch | 1 bottle | $2.083 | — | FDA listed | — |
| Zaditor .25 mg/mL 00065-4011-05 | Alcon | 1 bottle | $2.225 | — | Availability likely | — |
| Eye Itch Relief .35 mg/mL 00363-0038-05 | Walgreen | 1 bottle | — | — | FDA listed | — |
| Eye Itch Relief .25 mg/mL 11673-0064-05 | Target | 1 bottle | — | — | FDA listed | — |
| Eye Itch Releif .25 mg/mL 11822-5533-01 | Rite | 1 bottle | — | — | FDA listed | — |
| Eye Itch Relief .25 mg/mL 21130-0601-05 | Safeway | 1 bottle | — | — | FDA listed | — |
| Eye Itch Relief .25 mg/mL 30142-0398-05 | Kroger | 1 bottle | — | — | FDA listed | — |
| Eye Itch Relief .25 mg/mL 36800-0097-05 | TOPCO | 1 bottle | — | — | FDA listed | — |
| Equate Eye Itch Relief .25 mg/mL 49035-0231-10 | Wal-Mart | 1 bottle | — | — | FDA listed | — |
| Ketotifen Fumarate .25 mg/mL 50090-6472-00 | A-S | 1 bottle | — | — | FDA listed | — |
| Eye Itch Relief .25 mg/mL 50090-7253-00 | A-S | 1 bottle | — | — | FDA listed | — |
| Eye Itch Relief .25 mg/mL 50804-0601-05 | PERRIGO | 1 bottle | — | — | FDA listed | — |
| Eye Itch Relief .25 mg/mL 67296-2245-05 | Redpharm | 1 bottle | — | — | FDA listed | — |
| Ketotifen Fumarate Ophthalmic Solution .25 mg/mLthis 68788-4084-05 | Preferred | 1 bottle | — | — | FDA listed | — |
| Ketotifen Fumarate .25 mg/mL 68788-8715-05 | Preferred | 1 bottle | — | — | FDA listed | — |
| Eye Itch Relief .25 mg/mL 69842-0275-05 | CVS | 1 bottle | — | — | FDA listed | — |
| Ketotifen Fumarate .35 mg/mL 71205-0115-05 | Proficient | 1 bottle | — | — | 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
Feb 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.
🔬 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 Ketotifen Fumarate — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 26%
Female · 74%
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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 68788-4084-05 You're viewing this | 1 BOTTLE, DROPPER in 1 CARTON (68788-4084-5) / 5 mL in 1 BOTTLE, DROPPER | 2026-02-27 | Active |
🧭 About this NDC listing & data coverage
Over-the-counter (OTC) 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 | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| 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 68788-4084-5, 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: 68788-4084-05, written without dashes as 68788408405. 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 68788-4084-05, the first segment (68788) is the labeler code FDA assigned to Preferred Pharmaceuticals Inc.; the middle segment (4084) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) 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 Preferred Pharmaceuticals Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Preferred Pharmaceuticals Inc. 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 an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
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.
📄 FDA label — Drug Facts FDA SPL
The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage
⏱️ Dosage and Administration
⚠️ Warnings
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Use Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.
⏱️ Dosage and Administration ▾
Directions • Adults and children 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day. • Children under 3 years of age: Consult a doctor.
⚠️ Warnings ▾
Warnings Do not use • if solution changes color or becomes cloudy • if you are sensitive to any ingredient in this product • to treat contact lens related irritation When using this product • do not touch tip of container to any surface to avoid contamination • remove contact lenses before use • wait at least 10 minutes before reinserting contact lenses after use • replace cap after each use Stop use and ask a doctor if you experience any of the following: • eye pain • changes in vision • redness of the eye • itching worsens or lasts for more than 72 hours Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
📦 Storage and Handling ▾
Other information • Only for use in the eye. • Store at 20° to 25°C (68° TO 77°F) [see USP Controlled Room Temperature].
🧪 Active Ingredient ▾
Active ingredient Ketotifen (0.025%) (equivalent to Ketotifen Fumarate 0.035%)
🧪 Inactive Ingredients ▾
Inactive ingredients Benzalkonium Chloride 0.01%; Glycerin and Water for Injection. May contain Hydrochloric Acid and/or Sodium Hydroxide (to adjust pH).
🎯 Purpose ▾
Purpose Antihistamine
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 ↗
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.