Spain· ES:80485
DOLOMIDINA 500/25MG COMPRIMIDOS RECUBIERTOS CON PELICULA
A medicinal product containing paracetamol + difenhidramina, registered in Spain by Esteve Pharmaceuticals S.A..
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- paracetamol + difenhidramina
- Manufacturer
- Esteve Pharmaceuticals 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
Paracetamol + difenhidramina in 6 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesAcetaminophen and Diphenhydramine citrateInvaTech Pharma Solutions LLC
- United KingdomCalCold Six Plus oral solutionMcNeil Products Ltd
- IrelandDozol Oral Solution Paracetamol 120 mg/5 ml Diphenhydramine Hydrochloride 12.5 mg/5 mlPhoenix Healthcare Ltd
- CanadaACETAMINOPHEN WITH ANTIHISTAMINE NIGHTTIMELABORATOIRES TRIANON INC.
- PolandApap NocUS Pharmacia Sp. z o.o.
- FranceACTIFED RHUME JOUR ET NUIT, compriméKENVUE FRANCE
Authorised across Europe · EMA
The same active substance is authorised in 5 EEA countries. Names it is sold under:
- United Kingdom (Northern Ireland) · Panadol Night, Panadol Nightpain
- Ireland · Dozol, Panadol Night
- Malta · Dozol, Teedex
- Poland · Apap Noc, Paracetamol + Difenhydramina Noc Hasco
- Portugal · Algik Noite, Chrobion
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/c728f0c9-acd4-4328-9a18-992b18627c5d GET /v1/drugs/c728f0c9-acd4-4328-9a18-992b18627c5d?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\":1450166066000,\"susp\":1593503234000}",
"nregistro": "80485",
"substance": "paracetamol + difenhidramina"
}See everything about paracetamol + 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.