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Eye Itch Relief Ketotifen Fumarate .35 mg/mL Solution/ Drops

by CARDINAL HEALTH 110, LLC. DBA LEADER · 1 BOTTLE, DROPPER in 1 CARTON (70000-0124-1) / 5 mL in 1 BOTTLE, DROPPER
NDC 70000-0124-01
🏷️ FDA NDC (as labeled) 70000-0124-1 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 →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 70000-0124-1
Product NDC 70000-0124
11-digit billing NDC 70000012401
NCPDP billing unit ML — per mL (volume)
RxCUI 311237
UNII HBD503WORO
UPC 0096295128901
Application # ANDA077958
SPL Set ID add414c5-b6c5-4bb5-8d8a-ddc507a27131
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 2017-01-18
Marketing end 2028-03-31
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance KETOTIFEN FUMARATE
GPI-14 86802040102010
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
Why two NDCs? The FDA registers this code as 70000-0124-1 — 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 → 70000-0124-01. 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.

🏭 Manufacturer & labeler

LabelerCARDINAL HEALTH 110, LLC. DBA LEADER
Application holderSENTISS AG
FDA applicationANDA077958 (ANDA)
Labeler code70000
First marketedJan 2017
Product typeHuman Otc Drug
Portfolio163 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

Label name EYE ITCH RELIEF 0.025% DROPS Ingredient Ketotifen Fumarate
📗 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?
📖 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.

🧪 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.

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.

💲 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 $1.322 $6.61 / 5 ml
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.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Jan 2022 Feb 2022 $1.491 $1.322
▼ Down 11% over the last 3 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ketotifen Fumarate .25 mg/mL 00536-1252-40 Rugby 1 bottle $1.304 — Availability likely save 1%
Eye Itch Relief .25 mg/mL 70000-0522-01 Cardinal 1 bottle $1.304 — Availability likely save 1%
Ketotifen Fumarate Ophthalmic Solution .25 mg/mL 70244-0041-01 Sentiss 1 bottle $1.304 — Availability likely save 1%
Ketotifen Fumarate Ophthalmic Solution .25 mg/mL 72485-0617-10 Armas 1 bottle $1.304 — Availability likely save 1%
Ketotifen Fumarate .25 mg/mL 76385-0106-17 Unichem 1 bottle $1.304 — Availability likely save 1%
Eye Itch Relief .35 mg/mLthis 70000-0124-01 CARDINAL 1 bottle $1.322 — FDA listed —
Alaway .25 mg/mL 24208-0601-05 Bausch 1 bottle $2.083 — FDA listed +58%
Zaditor .25 mg/mL 00065-4011-05 Alcon 1 bottle $2.225 — Availability likely +68%
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 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

🏛️
2017
On the market since
Jan 2017
📍
2026
Currently FDA-listed
9 years 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
70000-0124-01 You're viewing this 1 BOTTLE, DROPPER in 1 CARTON (70000-0124-1) / 5 mL in 1 BOTTLE, DROPPER 2017-01-18 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 — Not published for this NDC No photo available yet for this listing.
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) ✓ Available
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

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 70000-0124-1, 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: 70000-0124-01, written without dashes as 70000012401. 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 70000-0124-01, the first segment (70000) is the labeler code FDA assigned to CARDINAL HEALTH 110, LLC. DBA LEADER; the middle segment (0124) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 it is currently marketed — but CARDINAL HEALTH 110, LLC. DBA LEADER has reported a marketing end date of 2028-03-31, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Who lists this product with the FDA?
CARDINAL HEALTH 110, LLC. DBA LEADER 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 14 words ▾

Uses Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

⏱️ Dosage and Administration 41 words ▾

Directions ▪ Adults and children 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8 to 12 hours, no more than twice per day. ▪ Children under 3 years of age: Consult a doctor

⚠️ Warnings 125 words ▾

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 the tip of container to any surface to avoid contamination ▪ remove contact lenses before use ▪ wait at least 10 minutes before reinserting contact lens 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 more than 72 hours Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 9 words ▾

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

🧪 Inactive Ingredients 19 words ▾

Inactive ingredients Benzalkonium Chloride 0.01%, Glycerin, Water for Injection. May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH.

🎯 Purpose 2 words ▾

Purpose Antihistamine

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70000-0112-01 · Cardinal 70000-0125-01 · 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.