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eye itch relief ketotifen fumarate 0.35 mg/mL Solution/ Drops — NDC 49348-107-17 (Billing 49348-0107-17)

by STRATEGIC SOURCING SERVICES LLC · 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER

This is a package of eye itch relief ketotifen fumarate 0.35 mg/mL Solution/ Drops from STRATEGIC SOURCING SERVICES LLC, no longer marketed, no longer in the FDA NDC Directory; retail pharmacies pay about $1.44 per mL (NADAC). It is this product's only package size.

NDC 49348-0107-17
🏷️ FDA NDC (as labeled) 49348-107-17 billing pads the product segment with a zero
OTC Generic Discontinued Non-controlled ⚠ Inactivated by FDA ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 14, 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 49348-107-17 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
49348 labeler · 107 product · 17 package
Barcode (UPC-A, from the NDC)
3 4934810717 1
FDA record last changed
Jul 14, 2026
⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2023. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 49348-107-17
Product NDC 49348-107
11-digit billing NDC 49348010717
NCPDP billing unit ML — per mL (volume)
Application # ANDA077958
SPL Set ID 1ff86d21-cf4b-4a53-9d73-be331160c37a
Established class (EPC) Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2023)
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance KETOTIFEN FUMARATE

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

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 SM EYE ITCH RELIEF 0.025% DROP
FDB brand name Eye Itch Relief
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 043118
  • GCN: 92451
  • HICL (First Databank): 006554
  • AHFS class code: 52:02.00.00
Why two NDCs? The FDA registers this code as 49348-107-17 — 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 → 49348-0107-17. 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.

Clinical

Label name SM EYE ITCH RELIEF 0.025% DROP 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 $1.442 $7.21 / 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 Feb 2022 May 2022 Aug 2022 $1.491 $1.279
▼ Down 3% over the last 9 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
49348-0107-17 You're viewing this Main listing 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER 2014-02-07 — Inactivated by FDA

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
eye itch relief 0.35 mg/mLthis 49348-0107-17 STRATEGIC 1 bottle $1.442 — Discontinued —
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

📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

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, Water for Injection. May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH.

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

LabelerSTRATEGIC SOURCING SERVICES LLC
Application holderSENTISS AG
FDA applicationANDA077958 (ANDA)
Labeler code49348
Product typeHuman Otc Drug
Portfolio316 products on file

More NDCs from STRATEGIC SOURCING SERVICES LLC labeler code 49348

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 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 14 words ▾

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

⏱️ Dosage and Administration 39 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 118 words ▾

Warnings For external use only 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 tip of container to any surface to avoid contamination remove contact lenses before use wait at least 10 minutes before reinserting contact lenses after use replace cap after each use Stop use and ask a doctor if you experience any of following: eye pain changes in vision redness of the eye itching 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. (1-800-222-1222)

🧪 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

📄 Do Not Use 26 words ▾

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 37 words ▾

When using this product do not touch tip of container to any surface to avoid contamination remove contact lenses before use wait at least 10 minutes before reinserting contact lenses after use replace cap after each use

📄 Stop Use and Ask a Doctor If 30 words ▾

Stop use and ask a doctor if you experience any of following: eye pain changes in vision redness of the eye itching worsens or lasts for more than 72 hours

📄 Keep Out of Reach of Children 20 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

📄 Other Information 21 words ▾

Other information only for use in the eye. store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

📄 Questions or Comments 19 words ▾

Questions or comments? 1-800-923-5676 Serious side effects associated with use of this product may be reported to this number

📄 Package Label / Principal Display Panel 98 words ▾

Principal Display Panel Text for Container Label: Sunmark Logo ® NDC 49348-107-17 sterile eye itch relief ketotifen fumarate ophthalmic solution 0.035% Antihistamine Eye Drops 5 mL (0.17 FL OZ) Principal Display Panel Text for Container Label

Principal Display Panel Text for Carton Label: Sunmark Logo ® COMPARE TO ZADITOR ® ACTIVE INGREDIENT* NDC 49348-107-17 sterile eye itch relief ketotifen fumarate ophthalmic solution 0.035% Antihistamine Eye Drops For ages 3 years and older 30-day supply Works in minutes Original Prescription Strength UP TO 12 HOURS OF RELIEF 5 mL (0.17 FL OZ) Principal Display Panel Text for Carton Label

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 No longer marketed (per FDA listing data)
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) ✓ 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

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Who lists this product with the FDA?
STRATEGIC SOURCING SERVICES LLC 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.
← 49348-0095-29 · Strategic 49348-0133-27 · Strategic →
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.