🆔 Identity & classification

FDA NDC (as labeled) 0536-1252-40

Product NDC 0536-1252

11-digit billing NDC 00536125240

NCPDP billing unit ML — per mL (volume)

RxCUI 311237

UNII HBD503WORO

Application # NDA021996

SPL Set ID 8aa81ae9-112a-49fa-a0cb-ed0217a40de5

Established class (EPC) Histamine-1 Receptor Inhibitor

Mechanism of action Histamine H1 Receptor Antagonists

DEA schedule Non-controlled

Marketing category NDA AUTHORIZED GENERIC

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2020-09-18

Route OPHTHALMIC

Dosage form SOLUTION/ DROPS

Substance KETOTIFEN FUMARATE

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

Why two NDCs? The FDA registers this code as 0536-1252-40 — a 4-4-2 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 labeler segment → 00536-1252-40. 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

LabelerRugby Laboratories

Application holderBAUSCH AND LOMB INC

FDA applicationNDA021996 (NDA AUTHORIZED GENERIC)

Labeler code00536

First marketedSep 2020

Product typeHuman Otc Drug

Portfolio149 products on file

🔎 All NDCs from Rugby Laboratories

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

📖 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?

📖 Read our full Ketotifen guide →

Patient education

📘 MedlinePlus patient leaflet ↗

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.

💡 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.

💲 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	$1.304	$6.52 / 5 ml
Medicaid paysCMS SDUD · 12 mo	$3.69	$18.44 / 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

▼ Down 13% 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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Ketotifen Fumarate .25 mg/mLthis 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	+1%
Alaway .25 mg/mL 24208-0601-05	Bausch	1 bottle	$2.083	—	FDA listed	+60%
Zaditor .25 mg/mL 00065-4011-05	Alcon	1 bottle	$2.225	—	Availability likely	+71%
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 an authorized generic — the brand-name product marketed without its brand name. 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

🏛️

2020

On the market since

Sep 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.

🗺️ 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 00536-1252-40, 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 – Q4 2025 · 4 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

210.9K

Units reimbursed last 4 qtrs

1.1M

Gross reimbursed last 4 qtrs

$4.18M

Avg / prescription

$19.79

Avg / unit

$3.6870

Latest quarter Q4 2025

44KRx

Medicaid pays / mL

$3.6870

gross reimbursed

vs

NADAC / mL

$1.3042

acquisition cost

=

Spread

+$2.3828

+183% 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 ⓘ

71% FFS 29% MCO

Fee-for-service · 149,328 Rx Managed care · 61,614 Rx

State Medicaid map

Units reimbursed · per 100k residents

0.82,802

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 2,802 /100k

2 New Jersey 917 /100k

3 Michigan 610 /100k

4 D.C. 577 /100k

5 Kentucky 554 /100k

6 California 495 /100k

7 New Mexico 372 /100k

8 Pennsylvania 366 /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.

🔬 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

Treatment Failure2,496

Eye Irritation637

Eye Pain276

Ocular Hyperaemia227

Pruritus219

Eye Pruritus214

Headache192

Age at onset

Infant1

Child14

Adolescent12

Adult272

Elderly155

Reporter sex

Male · 26%

Female · 74%

Unknown · 0%

Serious outcomes

Hospitalization493

Disabling45

Life-threatening39

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
00536-1252-40 You're viewing this	1 BOTTLE, DROPPER in 1 CARTON (0536-1252-40) / 5 mL in 1 BOTTLE, DROPPER	2020-09-18	Active

📄 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 17 words ▾

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

⏱️ Dosage and Administration 52 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 119 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 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 fumerate 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

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

🔗 Related NDC lookups

🧪 All Ketotifen Fumarate NDCsSame ingredient 🏭 All Rugby labeler NDCsLabeler code 00536 📚 All Histamine-1 Receptor Inhibitor NDCsDrug class

💊 Related drugs in this class

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

Alcaftadine 00023-4291-01 Olopatadine Hcl 00065-0816-01 Bepotastine Besilate 00378-7055-35 Azelastine Hcl 47335-0938-90 Epinastine Hcl 51991-0836-75 Cetirizine Hcl 71776-0024-30

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.

Ketotifen Fumarate .25 mg/mL Solution/ Drops

🆔 Identity & classification

🏷️ RxNorm drug class

🏭 Manufacturer & labeler

🩺 Clinical

Patient education

Supplement & herbal interactions

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

🗺️ Medicaid utilization & spend

🔬 Reported adverse events (FAERS)

Top reported reactions

Age at onset

Reporter sex

Serious outcomes

📦 Packaging — all sizes for this product

📄 FDA label — Drug Facts FDA SPL

🔗 Related NDC lookups

💊 Related drugs in this class