United States· US:0363-0038_4ddfb3f8-812d-c7c4-e063-6394a90a284d
Eye Itch Relief
A ketotifen product containing ketotifen fumarate, registered in United States by Walgreen Company. The same ATC class is registered in 13 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Ketotifen is registered in 13 of 19 countries.
Countries holding a registration under ATC S01GX08 (ketotifen), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 8 of them publish a price we can compare per daily dose
Ketotifen · ATC S01GX08
13 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- KETOTIFEN FUMARATE
- Manufacturer
- Walgreen Company
- Country
- United States (US)
- ATC code
- S01GX08
- ATC class
- Ketotifen
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 4
- ndc1103630038051 BOTTLE in 1 CARTON (0363-0038-05) / 5 mL in 1 BOTTLE
- ndc1103630038101 BOTTLE in 1 CARTON (0363-0038-10) / 10 mL in 1 BOTTLE
- ndc110363-0038-05
- ndc110363-0038-10
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Ketotifen in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaKETOFHexal AG, Holzkirchen
- United KingdomKetofall 0.25mg/ml eye drops 0.4ml unit doseScope Ophthalmics Ltd
- NetherlandsAltriabak 0,25 mg/ml, oogdruppels, oplossingEuro Registratie Collectief B.V.
- SpainBENTIFEN 0,25mg/ml COLIRIO EN SOLUCIONLaboratoires Thea
- FinlandBentifenNovartis Healthcare A/S
- NorwayKetazedHorus Pharma
- GermanyAllergo-Vision SineOmnivision Gmbh
- BelgiumAltriabak 0.25 mg/mlLaboratoires Théa
Authorised across Europe · EMA
The same active substance is authorised in 25 EEA countries. Names it is sold under:
- Austria · Ketotifen Stulln, Ketotifen Stulln 0,25 Mg/Ml Augentropfen Pharma Stulln
- Belgium · Altriabak, Ketazed
- Bulgaria · Ketotifen Sopharma, Забак
- Cyprus · Meni-Drops, Tenerel
- Czechia · Ketof, Ketotifen Al
- Germany · Allergo-Vision Sine, Ketazed
- Denmark · Ketazed, Zaditen
- Spain · Bentifen, Ketisal
- Finland · Ketazed, Ketotifen Stulln 0,25 Mg/Ml Silmätipat, Liuos
- France · Ketazed, Monoketo
- United Kingdom (Northern Ireland) · Ketazed, Ketofall
- Greece · Cleroptic, K-Drops
- Ireland · Ketofall, Zaditen
- Iceland · Zaditen
- Italy · Brunistill, Chetotifene Mylan Generics
- Luxembourg · Altriabak, Ketazed
- Latvia · Ketotifen
- Netherlands · Altriabak, Ketazed
- Norway · Ketazed, Zaditen
- Poland · Ketotifen Hasco, Ketotifen Stulln
- Portugal · Lidina, Lidinafree
- Romania · Ketazed, Ketof
- Sweden · Bentifen, Ketazed
- Slovenia · Zaditen, Zaditen Sdu
- Slovakia · Denerel, Zaditen
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/a8a7e0ab-b5fc-4743-b301-687c36f25cc8 GET /v1/drugs/a8a7e0ab-b5fc-4743-b301-687c36f25cc8?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "OPHTHALMIC",
"source": "ndc",
"strength": ".35",
"substance": "KETOTIFEN FUMARATE",
"productndc": "0363-0038",
"dosage_form": "SOLUTION",
"dea_schedule": null,
"strength_unit": "mg/mL",
"application_number": "NDA021996",
"marketing_category": "NDA"
}See everything about ketotifen.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.