Belgium· BE-AMP-SAM034212-00
Trihistalex 20 mg/g
A antipruritics, incl. antihistamines, anesthetics, etc. product containing diphenhydramine hydrochloride, registered in Belgium by Pharinex.
Checked against FAMHP / AFMPS (Belgium) on
Informational only — not a medical device.
The record
At a glance
FAMHP / AFMPS (Belgium)- Active substance
- Diphenhydramine Hydrochloride
- Manufacturer
- Pharinex
- Country
- Belgium (BE)
- ATC code
- D04A
- ATC class
- ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
- Reimbursed
- Not published by this register
- Source register
- FAMHP / AFMPS (Belgium)
- Last checked
- September 26, 2026
Packs & prices · 1
- be_apb0090944
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Diphenhydramine hydrochloride in 11 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesA Health Itch Relief GelBionpharma, Inc.
- CanadaALLERGY FORMULAJUNO OTC INC
- United KingdomAdult Meltus Night Time syrupSSL International Plc
- GermanyBetadorm-DRecordati Pharma Gmbh
- NorwayDiphenhydramine eonEon Labs
- SwitzerlandBenocten, TablettenMedinova AG
- PolandLuminastilAflofarm Farmacja Polska Sp. z o.o.
- SpainDIFENHIDRAMINA OMEGA PHARMA 50 MG COMPRIMIDOSOmega Pharma España, S.A.
Authorised across Europe · EMA
The same active substance is authorised in 19 EEA countries. Names it is sold under:
- Austria · Calmaben, Dermodrin
- Bulgaria · Дермодрин, Калмабен
- Czechia · Psilo-Balsam
- Germany · Betadorm-D, Diphenhydramin Hevert
- Denmark · Benylan, Coldycof
- Spain · Neosayomol, Soñodor
- 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 FAMHP / AFMPS (Belgium). 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/d636a026-00bf-43b2-af97-d4c7c73fc135 GET /v1/drugs/d636a026-00bf-43b2-af97-d4c7c73fc135?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.
{
"form": "Cream",
"source": "afmps",
"status": "AUTHORIZED",
"name_en": "Trihistalex 20 mg/g",
"name_fr": "Trihistalex 20 mg/g",
"name_nl": "Trihistalex 20 mg/g",
"amp_code": "SAM034212-00",
"strengths": [
"2.0000",
"2.0000",
"2.0000",
"2.0000",
"1.0000",
"1.0000",
"14.2500",
"1.9000",
"50.0000",
"50.0000",
"4.7500"
],
"pack_count": 1,
"substances": [
"Diphenhydramine Hydrochloride",
"Nicotinamide",
"Cinchocaine Hydrochloride",
"Cetyl Alcohol",
"Glycerol",
"Methyl Parahydroxybenzoate",
"Propyl Parahydroxybenzoate",
"Polysorbate 20"
],
"medicine_type": "ALLOPATHIC",
"atc_description": "Antipruritics, Incl. Antihistamines, Anesthetics, Etc.",
"authorisation_numbers": [
"BE034212"
]
}See everything about diphenhydramine hydrochloride.
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.