Spain· ES:83596
DIFENHIDRAMINA OMEGA PHARMA 50 MG COMPRIMIDOS
A medicinal product containing difenhidramina, registered in Spain by Omega Pharma España, S.A..
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- difenhidramina
- Manufacturer
- Omega Pharma España, S.A.
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- June 3, 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
Difenhidramina in 11 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CanadaALLERGY FORMULA EXTRA STRENGTHVITA HEALTH PRODUCTS INC
- United KingdomDiphenhydramine 50mg tabletsEnnogen Healthcare Ltd
- United StatesAllergy ReliefAMERISOURCE BERGEN
- PolandLuminastilAflofarm Farmacja Polska Sp. z o.o.
- IrelandNytol One-A-Night 50 mg TabletsChefaro Ireland DAC,
- NorwayDiphenhydraminhydrochlorid glostrupGlostrup Apotek
- GermanyBetadorm-DRecordati Pharma Gmbh
- BelgiumAzaron 20 mg/g LotionPerrigo Belgium
Authorised across Europe · EMA
The same active substance is authorised in 19 EEA countries. Names it is sold under:
- Austria · Calmaben, Dermodrin
- Belgium · Nustasium, R Calm
- Bulgaria · Дермодрин, Калмабен
- Czechia · Psilo-Balsam
- Germany · Betadorm-D, Diphenhydramin Hevert
- Denmark · Benylan, Coldycof
- United Kingdom (Northern Ireland) · Almus Max Strength Sleep Aid, Asda Night Time Sleep Aid
- Hungary · Supraderm
- Ireland · Nytol One-A-Night
- Iceland · Benylan
- Italy · Allergan
- Lithuania · Psilo-Balsam
- Luxembourg · Nustasium
- Latvia · Pretniezes, Psilo-Balsam
- Poland · Luminastil, Nodisen
- Portugal · Benaderma, Benergina
- Romania · Calmaben, Dermodrin
- Sweden · Desentol
- Slovakia · Calmaben, Psilo-Balsam
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/58d0c0bc-21b0-43c7-a5f9-fa7398faf813 GET /v1/drugs/58d0c0bc-21b0-43c7-a5f9-fa7398faf813?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\":1552950000000,\"rev\":1651141149000}",
"nregistro": "83596",
"substance": "difenhidramina"
}See everything about difenhidramina.
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.