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Eye Itch Relief ketotifen fumarate .25 mg/mL Solution — NDC 70000-0522-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Eye Itch Relief ketotifen fumarate .25 mg/mL Solution — NDC 70000-0522-1 (Billing 70000-0522-01)

by Cardinal Health · 1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE

This is a package of Eye Itch Relief ketotifen fumarate .25 mg/mL Solution from Cardinal Health, marketed since Aug 2020 and currently FDA-listed; retail pharmacies pay about $1.29 per mL (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 70000-0522-01
🏷️ FDA NDC (as labeled) 70000-0522-1 billing pads the package segment with a zero
This package
Contains5 mL in 1 bottle Cost per mL$1.29 NADAC Per package$6.47 / 5 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $3.98/unit — full pricing hub ↓
Main listing for product 70000-0522 · Also comes in: 10 mL 70000-0522-2
OTC Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70000-0522-1
Product NDC 70000-0522
11-digit billing NDC 70000052201
NCPDP billing unit ML — per mL (volume)
RxCUI 311237
UNII HBD503WORO
UPC 0096295138887
Application # NDA021996
SPL Set ID e5fd1246-c4a7-4be3-a3d3-83d82ec6cab8
Established class (EPC) Histamine-1 Receptor Inhibitor
Mechanism of action Histamine H1 Receptor Antagonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-08-07
Route OPHTHALMIC
Dosage form SOLUTION
Substance KETOTIFEN FUMARATE

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

GPI-14 86802040102011
GPI class Eye Itch Relief
GCN Seq No 043118
GCN 92451
HICL code 006554
Ingredient (HICL) Ketotifen Fumarate
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 Q6R
Therapeutic class — specific (HIC3) Eye Antihistamines
AHFS code 52:02.00.00
AHFS class Antiallergic Agents
FDB label name EYE ITCH RELIEF 0.025% DROPS
FDB brand name Eye Itch Relief
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 043118
  • GCN: 92451
  • GPI-14 (Medi-Span): 86802040102011
  • HICL (First Databank): 006554
  • AHFS class code: 52:02.00.00
  • RxCUI (RxNorm): 311237
Why two NDCs? The FDA registers this code as 70000-0522-1 — 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 → 70000-0522-01. 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.

Clinical

Label name EYE ITCH RELIEF 0.025% DROPS Ingredient Ketotifen Fumarate
📖 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
  • It relieves or prevents itchy eyes from allergies. The drops give temporary relief from itching due to pollen, ragweed, grass, and animal hair and dander. The ACUVUE Theravision le...
  • If you are an adult or a child 3 or older, use 1 drop in each affected eye twice a day, 8 to 12 hours apart. Don't use them more than twice daily. If your child is under 3, check w...
  • Take your contact lenses out before using the drops. Then wait at least 10 minutes before putting them back in. If you use other eye products too, leave at least 5 minutes between...
  • Stop the drops and talk to a doctor if you have eye pain, changes in vision, redness, or itching that gets worse or lasts more than 72 hours. With the ACUVUE Theravision lens, take...
📖 Read our full Ketotifen guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 $1.294 $6.47 / 5 ml
Medicaid paysCMS SDUD · 12 mo $3.98 $19.89 / 5 ml
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
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $1.537 $1.279
▼ Down 12% over the last 24 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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
70000-0522-01 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE $1.29 / mL $6.47 2020-08-07 — Active
70000-0522-02 70000-0522-2 1 BOTTLE in 1 CARTON / 10 mL in 1 BOTTLE $0.4390 / mL $4.39 2020-08-07 — Active

Per mL, this pack runs about 195% above the cheapest pack (NDC 70000-0522-02, $0.4390 vs $1.29 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle in 1 carton / 5 ml in 1 bottle.
What NDC number is used to bill for this package of Eye Itch Relief ketotifen fumarate .25 mg/mL Solution?
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.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ketotifen Fumarate .25 mg/mL 00536-1252-40 Rugby 1 bottle $1.294 — Availability likely —
Eye Itch Relief .25 mg/mLthis 70000-0522-01 Cardinal 1 bottle $1.294 — Availability likely —
Ketotifen Fumarate Ophthalmic Solution .25 mg/mL 70244-0041-01 Sentiss 1 bottle $1.294 — Availability likely —
Ketotifen Fumarate Ophthalmic Solution .25 mg/mL 72485-0617-10 Armas 1 bottle $1.294 — Availability likely —
Ketotifen Fumarate .25 mg/mL 76385-0106-17 Unichem 1 bottle $1.294 — Availability likely —
Eye Itch Relief .35 mg/mL 70000-0124-01 CARDINAL 1 bottle $1.322 — FDA listed +2%
Alaway .25 mg/mL 24208-0601-05 Bausch 1 bottle $2.083 — FDA listed +61%
Zaditor .25 mg/mL 00065-4011-05 Alcon 1 bottle $2.229 — Availability likely +72%
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/mL 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 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

🏛️
2020
On the market since
Aug 2020
📍
2026
Currently FDA-listed
6 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

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

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.

💡 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, hydrochloric acid and/or sodium hydroxide, water for injection

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.

Manufacturer & labeler

LabelerCardinal Health
Application holderBAUSCH AND LOMB INC
FDA applicationNDA021996 (NDA)
Labeler code70000
First marketedAug 2020
Product typeHuman Otc Drug
Portfolio84 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.

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 17 words ▾

Uses For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.

⏱️ Dosage and Administration 56 words ▾

Directions ▪ Adults and children 3 years and older: ▪ put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day ▪ if using other ophthalmic products while using this product, wait at least 5 minutes between each product ▪ Children under 3 years of age: consult a doctor

⚠️ Warnings 111 words ▾

Warnings For external use only Do not use • if you are sensitive to any ingredient in this product • if solution changes color or becomes cloudy • to treat contact lens related irritation When using this product • remove contact lenses before use • wait at least 10 minutes before re-inserting contact lenses after use • do not touch tip of container to any surface to avoid contamination • 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 eyes • itching that worsens or lasts for more than 72 hours

🧪 Active Ingredient 9 words ▾

Active ingredient Ketotifen 0.025% (equivalent to ketotifen fumarate 0.035%)

🧪 Inactive Ingredients 14 words ▾

Inactive ingredients benzalkonium chloride 0.01%, glycerin, hydrochloric acid and/or sodium hydroxide, water for injection

🎯 Purpose 2 words ▾

Purpose Antihistamine

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Package Label / Principal Display Panel 57 words ▾

Package/Label Principal Display Panel LEADER[heart icon]™ NDC 70000-0522-2 Sterile / Eye Drops Eye Itch Relief ketotifen fumarate ophthalmic solution 0.035% ANTIHISTAMINE EYE DROPS Up to 12 Hours Works in Minutes Original Prescription Strength For Ages 3 Years and Older COMPARE to Systane ZADITOR active ingredient* 100% Money Back Guarantee

0.34 FL OZ (10 mL) 9688902 F860109 carton

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
98.6K
Units reimbursed last 4 qtrs
520.1K
Gross reimbursed last 4 qtrs
$2.07M
Avg / prescription
$21.00
Avg / unit
$3.9782
Latest quarter Q1 2026
20.6KRx
Medicaid pays / mL
$3.9782
gross reimbursed
vs
NADAC / mL
$1.2940
acquisition cost
=
Spread
+$2.6842
+207% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
81% FFS 19% MCO
Fee-for-service · 79,543 Rx Managed care · 19,007 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: 380 units · 33.6 per 100k residents MT North Dakota: no data reported ND Minnesota: 4,250 units · 74.1 per 100k residents MN Wisconsin: 750 units · 12.7 per 100k residents WI Michigan: 14,598 units · 145 per 100k residents MI New York: 360,993 units · 1,845 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 365 units · 11.4 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 260 units · 2.1 per 100k residents IL Indiana: 197 units · 2.9 per 100k residents IN Ohio: 9,070 units · 77.0 per 100k residents OH Pennsylvania: 19,484 units · 150 per 100k residents PA New Jersey: 41,069 units · 442 per 100k residents NJ Massachusetts: 4,975 units · 71.1 per 100k residents MA California: 45,835 units · 118 per 100k residents CA Utah: no data reported UT Colorado: 445 units · 7.6 per 100k residents CO Nebraska: 910 units · 46.0 per 100k residents NE Missouri: no data reported MO Kentucky: 5,828 units · 129 per 100k residents KY West Virginia: no data reported WV Virginia: 1,335 units · 15.3 per 100k residents VA Maryland: 5,300 units · 85.8 per 100k residents MD Connecticut: no data reported CT Rhode Island: 55 units · 5.0 per 100k residents RI Arizona: 1,180 units · 15.9 per 100k residents AZ New Mexico: 255 units · 12.1 per 100k residents NM Kansas: 755 units · 25.7 per 100k residents KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: 60 units · 1.1 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 950 units · 8.6 per 100k residents GA D.C.: 838 units · 123 per 100k residents DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
1.11,845
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 1,845 /100k
2 New Jersey 442 /100k
3 Pennsylvania 150 /100k
4 Michigan 145 /100k
5 Kentucky 129 /100k
6 D.C. 123 /100k
7 California 118 /100k
8 Maryland 85.8 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 bottle this page70000-0522-01 98,550 Rx · $2,069,189
1 bottle70000-0522-02 31 Rx · $905
Drug total (last 4 qtrs): 98,581 Rx · 520,410 units · $2,070,094 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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 Eye Itch Relief (this brand).

Top reported reactions

Treatment Failure141
Pruritus125
Urticaria113
Nausea90
Dyspnoea88
Fatigue86
Diarrhoea85

Age at onset

Child6
Adolescent5
Adult162
Elderly57

Reporter sex

1,153 reports
Male · 30%
Female · 70%
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 147 79
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.
← 70000-0521-01 · Cardinal 70000-0523-01 · Cardinal →
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.