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Alaway Ketotifen Fumarate .25 mg/mL Solution/ Drops — NDC 24208-0601-90 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Alaway Ketotifen Fumarate .25 mg/mL Solution/ Drops — NDC 24208-601-90 (Billing 24208-0601-90)

by Bausch & Lomb Incorporated · 2 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER

This is a package of Alaway Ketotifen Fumarate .25 mg/mL Solution/ Drops from Bausch & Lomb Incorporated, marketed since Dec 2006 and currently FDA-listed.

NDC 24208-0601-90
🏷️ FDA NDC (as labeled) 24208-601-90 billing pads the product segment with a zero
This package
Contains10 mL in 1 bottle, dropper Pack sizes3 compare ↓
Product page 24208-0601-10 Also comes in: 5 mL 24208-601-05 10 mL 24208-601-10
OTC Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 24208-601-90 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
24208 labeler · 601 product · 90 package
Package marketed since
Dec 1, 2006
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 2420860190 7
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 24208-601-90
Product NDC 24208-601
11-digit billing NDC 24208060190
NCPDP billing unit ML — per mL (volume)
RxCUI 311237, 707594
UNII HBD503WORO
Application # NDA021996
SPL Set ID e4c310b5-1dba-4ddc-bc90-b27ebc765871
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 2006-12-01
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance KETOTIFEN FUMARATE

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

GPI-14 86802040102011
GPI class Alaway Childrens Allergy
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 ALAWAY 0.025% EYE DROPS
FDB brand name Alaway
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 24208-601-90 — 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 → 24208-0601-90. 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 ALAWAY 0.025% EYE DROPS Ingredient Ketotifen Fumarate
📗 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 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: 5 mL 10 mL
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
24208-0601-05 24208-601-05 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER $2.08 / mL $10.42 2006-12-01 — Active
24208-0601-10 24208-601-10 Main listing 1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER $0.8650 / mL $8.65 2006-12-01 — Active
24208-0601-90 You're viewing this 2 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER — — 2006-12-01 — Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 2 bottle, dropper in 1 carton / 10 ml in 1 bottle, dropper.
What NDC number is used to bill for this package of Alaway Ketotifen Fumarate .25 mg/mL Solution/ Drops?
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/mL 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 —
Zaditor .25 mg/mL 00065-4011-05 Alcon 1 bottle $2.229 — 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 — — Discontinued —
Eye Itch Relief .25 mg/mL 21130-0601-05 Safeway 1 bottle — — FDA listed —
Alaway .25 mg/mLthis 24208-0601-90 Bausch 2 bottles — — 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

🏛️
2006
On the market since
Dec 2006
📍
2026
Currently FDA-listed
20 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.

🧪 Avoiding an ingredient? See Ketotifen inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 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

LabelerBausch & Lomb Incorporated
Application holderBAUSCH AND LOMB INC
FDA applicationNDA021996 (NDA)
Labeler code24208
First marketedDec 2006
Product typeHuman Otc Drug
Portfolio92 products on file

More NDCs from Bausch & Lomb Incorporated labeler code 24208

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 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 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 130 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

📄 When Using This Product 41 words ▾

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 36 words ▾

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 19 words ▾

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

📄 Questions or Comments 7 words ▾

Questions or comments? [Phone icon] Call: 1-800-553-5340

📄 Package Label / Principal Display Panel 52 words ▾

Package/Label Principal Display Panel TWIN PACK NDC 24208-601-90 BAUSCH + LOMB Alaway ® ketotifen fumarate ophthalmic solution 0.035% ANTIHISTAMINE EYE DROPS Eye Itch Relief UP TO 12 HOURS Works in Minutes Original Prescription Strength For Ages 3 Years And Older 2x 10 mL BOTTLES STERILE

0.34 FL OZ EACH 3842002 AB60192A Carton

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

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 bottle24208-0601-10 17,221 Rx · $297,269
1 bottle24208-0601-05 189 Rx · $2,924
2 bottles this page24208-0601-90 No Medicaid data
Drug total (last 4 qtrs): 17,410 Rx · 175,739 units · $300,194 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 Alaway (this brand).

Top reported reactions

Eye Irritation451
Eye Pain190
Pruritus154
Treatment Failure149
Ocular Hyperaemia138
Urticaria125
Headache115

Reporter sex

2,556 reports

Serious outcomes

Death28
Life-threatening27
Disabling23
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 241 0
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.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Bausch & Lomb Incorporated. 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 2 other package presentations of this same product, including 1 bottle (24208-0601-05), 1 bottle (24208-0601-10). 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?
Bausch & Lomb Incorporated 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.
← 24208-0590-64 · Bausch 24208-0602-03 · Bausch →
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.