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Eye Itch Relief ketotifen fumarate .25 mg/mL Solution/ Drops — NDC 30142-0398-05 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/ Drops — NDC 30142-398-05 (Billing 30142-0398-05)

by Kroger Company · 1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE

This is a package of Eye Itch Relief ketotifen fumarate .25 mg/mL Solution/ Drops from Kroger Company, marketed since Jun 2022 and currently FDA-listed. It is this product's only package size.

NDC 30142-0398-05
🏷️ FDA NDC (as labeled) 30142-398-05 billing pads the product segment with a zero
OTC Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 30142-398-05 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
30142 labeler · 398 product · 05 package
Package marketed since
Jun 1, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0041260103407
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 30142-398-05
Product NDC 30142-398
11-digit billing NDC 30142039805
RxCUI 311237
UNII HBD503WORO
UPC 0041260103407
Application # NDA021996
SPL Set ID eb81286f-72b4-42b3-a596-439d0aeae93f
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 2022-06-01
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance KETOTIFEN FUMARATE
Quick answers
  • RxCUI (RxNorm): 311237
Why two NDCs? The FDA registers this code as 30142-398-05 — 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 → 30142-0398-05. 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

📗 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.
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 Marketing startMarketing endStatus
30142-0398-05 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE 2022-06-01 — Active

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 —
Alaway .25 mg/mL 24208-0601-05 Bausch 1 bottle $2.083 — FDA listed —
Zaditor .25 mg/mL 00065-4011-05 Alcon 1 bottle $2.229 — 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 — — FDA listed —
Eye Itch Relief .25 mg/mL 21130-0601-05 Safeway 1 bottle — — FDA listed —
Eye Itch Relief .25 mg/mLthis 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

🏛️
2022
On the market since
Jun 2022
📍
2026
Currently FDA-listed
4 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

LabelerKroger Company
Application holderBAUSCH AND LOMB INC
FDA applicationNDA021996 (NDA)
Labeler code30142
First marketedJun 2022
Product typeHuman Otc Drug
Portfolio261 products on file

More NDCs from Kroger Company labeler code 30142

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 📄 Other Information 📄 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 64 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 Other information store at 4-25 °C (39-77 °F)

⚠️ 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 fumarate 0.035%)

🧪 Inactive Ingredients 61 words ▾

Inactive ingredients benzalkonium chloride 0.01%, glycerin, hydrochloric acid and/or sodium hydroxide, water for injection Questions or comments? [phone icon]Call: 1-800-632-6900 DISTRIBUTED BY: THE KROGER CO., CINCINNATI, OHIO 45202 PRODUCT OF ITALY *Systane® and Zaditor® are registered trademarks of Alcon, Inc., Fribourg, Switzerland CH-1701. Alcon, Inc. is not affiliated with The Kroger Co. or this product. QUALITY GUARANTEE 1-800-632-6900 www.kroger.com 9767401 MK60107

🎯 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.

📄 Other Information 8 words ▾

Other information store at 4-25 °C (39-77 °F)

📄 Questions or Comments 47 words ▾

Questions or comments? [phone icon]Call: 1-800-632-6900 DISTRIBUTED BY: THE KROGER CO., CINCINNATI, OHIO 45202 PRODUCT OF ITALY *Systane® and Zaditor® are registered trademarks of Alcon, Inc., Fribourg, Switzerland CH-1701. Alcon, Inc. is not affiliated with The Kroger Co. or this product. QUALITY GUARANTEE 1-800-632-6900 www.kroger.com 9767401 MK60107

📄 Package Label / Principal Display Panel 6 words ▾

Package/Label Principal Display Panel carton 5ml

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

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.

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 Kroger Company. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Kroger Company 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.
← 30142-0394-55 · Kroger 30142-0402-62 · Kroger →
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.