Ireland· IE-PA-PA1186/016/001
Nytol One-A-Night 50 mg Tablets
A diphenhydramine product containing diphenhydramine hydrochloride, registered in Ireland by Chefaro Ireland DAC,. The same ATC class is registered in 12 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Diphenhydramine is registered in 12 of 19 countries.
Countries holding a registration under ATC R06AA02 (diphenhydramine), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 6 of them publish a price we can compare per daily dose
Diphenhydramine · ATC R06AA02
12 / 19 countries
- Belgiumprice
- Canada
- Denmark
- Germany
- Icelandprice
- Ireland
- Japan
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
HPRA (Ireland)- Active substance
- Diphenhydramine hydrochloride
- Manufacturer
- Chefaro Ireland DAC,
- Country
- Ireland (IE)
- ATC code
- R06AA02
- ATC class
- Diphenhydramine
- Defined daily dose
- 0.2 g, O
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberPA1186/016/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
469 interactions on record for diphenhydramine.
Graded by severity as the source publishes them — 14 severe. Severity grades are free for everyone; mechanism and management come with Growth.
- Severity for every pair — free, no plan needed
- The source, licence and sync date on every record
- Mechanism and what to do for each pair — Growth plan
Diphenhydramine · interactions on record
469 records
- 14 severe
- 417 moderate
- 2 minor
Most severe, free to view
- Potassium chlorideA12BA01severe
- Potassium citrateA12BA02severe
- EliglustatA16AX10severe
- Potassium chlorideB05XA01severe
36 more interactions with mechanism and management, from a commercially licensed source.
Sign in to check- Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Same medicine, other countries
Diphenhydramine 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 tabletsDE Pharmaceuticals
- United StatesAllergy ReliefAMERISOURCE BERGEN
- SpainDIFENHIDRAMINA OMEGA PHARMA 50 MG COMPRIMIDOSOmega Pharma España, S.A.
- PolandLuminastilAflofarm Farmacja Polska Sp. z o.o.
- 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
- Spain · Neosayomol, Soñodor
- United Kingdom (Northern Ireland) · Almus Max Strength Sleep Aid, Asda Night Time Sleep Aid
- Hungary · Supraderm
- 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 HPRA (Ireland). 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/1e2f531c-b69d-4714-af8a-ea68218cddfb GET /v1/drugs/1e2f531c-b69d-4714-af8a-ea68218cddfb?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": "Tablet",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"R06AA",
"R06AA02"
],
"strength": null,
"pa_number": "PA1186/016/001",
"substances": [
"Diphenhydramine hydrochloride"
],
"legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)",
"market_info": "Marketed",
"authorised_at": "26/05/2017",
"dispensing_status": "Product not subject to medical prescription",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": null
}See everything about diphenhydramine.
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.