NDC 49035-0231-10 — Equate Eye Itch Relief ketotifen fumarate .25

🆔 Identity & classification

FDA NDC (as labeled) 49035-231-10

Product NDC 49035-231

11-digit billing NDC 49035023110

NCPDP billing unit ML — per mL (volume)

RxCUI 311237

UNII HBD503WORO

Application # NDA021996

SPL Set ID accb5fe9-b3d0-4e2e-a3f0-e7d16873bbb9

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 2016-01-01

Route OPHTHALMIC

Dosage form SOLUTION

Substance KETOTIFEN FUMARATE

GPI-14 86802040102011

GPI class EQ Eye Itch Relief

Why two NDCs? The FDA registers this code as 49035-231-10 — 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 → 49035-0231-10. 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

LabelerWal-Mart Stores, Inc.

Application holderBAUSCH AND LOMB INC

FDA applicationNDA021996 (NDA)

Labeler code49035

First marketedJan 2016

Product typeHuman Otc Drug

Portfolio83 products on file

🔎 All NDCs from Wal-Mart Stores, Inc.

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?

📖 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	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: 2 bottles

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/mLthis 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

🏛️

2016

On the market since

Jan 2016

📍

2026

Currently FDA-listed

10 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.

🔬 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 Equate Eye Itch Relief (this brand).

Top reported reactions

Treatment Failure141

Pruritus125

Urticaria113

Nausea89

Dyspnoea88

Fatigue85

Hypersensitivity83

Reporter sex

Male · 30%

Female · 70%

Serious outcomes

Life-threatening26

Disabling20

Death20

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
49035-0231-10 You're viewing this	1 BOTTLE in 1 CARTON (49035-231-10) / 10 mL in 1 BOTTLE	2016-01-01	Active
49035-0231-11	2 BOTTLE in 1 CARTON (49035-231-11) / 10 mL in 1 BOTTLE	2018-07-02	Active

Pack size FAQ

What quantity is in NDC 49035-0231-10?

NDC 49035-0231-10 is listed by the FDA — 1 bottle in 1 carton / 10 ml in 1 bottle.

What NDC number is used to bill for this package of Equate Eye Itch Relief ketotifen fumarate .25 mg/mL Solution?

Bill NDC 49035-0231-10 — the 11-digit billing format is 49035023110. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 49035-231-10, 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: 49035-0231-10, written without dashes as 49035023110. 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 49035-0231-10, the first segment (49035) is the labeler code FDA assigned to Wal-Mart Stores, Inc.; the middle segment (0231) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) 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 Wal-Mart Stores, Inc.. 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 2 bottles (49035-0231-11). 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?

Wal-Mart Stores, 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 🧪 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 41 words ▾

Directions Adults and children 3 years or 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 Other information Store at 4-25°C (39-77°F)

⚠️ 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

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 Wal-Mart labeler NDCsLabeler code 49035 📚 All Histamine-1 Receptor Inhibitor NDCsDrug class