Spain· ES:54083
FENISTIL 1 mg/g GEL
A medicinal product containing dimetindeno, registered in Spain by Haleon Spain S.A..
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- dimetindeno
- Manufacturer
- Haleon Spain S.A.
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- September 12, 2026
Packs & prices · 0
No packs listed by the register for this record.
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Dimetindeno in 7 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaBELDIMETBELUPO lijekovi i kozmetika, d.d., Koprivnica
- PolandAleric ŻelUS Pharmacia Sp. z o.o.
- SwitzerlandDimetindene Leman
- GermanyDimestilGrindeks
- BelgiumFenistil 0.1 %Haleon Belgium
- IrelandPruridene 1 mg/g GelCitrine Healthcare Limited
- NorwayFenistilNovartis (2)
Authorised across Europe · EMA
The same active substance is authorised in 21 EEA countries. Names it is sold under:
- Austria · Dimestil, Fenistil
- Belgium · Fenistil
- Bulgaria · Диместил, Полеспот
- Cyprus · Fenedim, Fenistil
- Czechia · Beldimet, Dimalen
- Germany · Dimestil, Dimetin Adgc
- Estonia · Dimestil
- Greece · Chingor, Dimestil
- Croatia · Belodin A Derm, Dimetindenmaleat Grindeks
- Hungary · Dimestil, Fenistil
- Ireland · Pruridene
- Italy · Dimetindene Alkaloid-Int, Fenistil
- Lithuania · Fenistil, Frest
- Luxembourg · Fenistil, Fenistil Dragees
- Latvia · Dimestil, Fenistil
- Malta · Fenistil
- Poland · Aleric Żel, Allertec Foxill
- Portugal · Balpic, Dimetindeno Benadermapic
- Romania · Calemo, Fenistil
- Slovenia · Fenistil, Flenty
- Slovakia · Fenimax, Fenistil
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 AEMPS CIMA (Spain). 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/bd3197ff-34e1-45b5-bc37-53024bf5f045 GET /v1/drugs/bd3197ff-34e1-45b5-bc37-53024bf5f045?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.
{
"cpresc": "Sin Receta",
"estado": "{\"aut\":276040800000}",
"nregistro": "54083",
"substance": "dimetindeno"
}See everything about dimetindeno.
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.