Ireland· IE-PA-PA23490/009/001
Oraldene 0.1% w/v Gargle/Mouthwash
A hexetidine product containing hexetidine, registered in Ireland by JNTL Consumer Health I (Ireland) Limited. The same ATC class is registered in 5 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Hexetidine is registered in 5 of 19 countries.
Countries holding a registration under ATC A01AB12 (hexetidine), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 2 of them publish a price we can compare per daily dose
Hexetidine · ATC A01AB12
5 / 19 countries
- Belgiumprice
- Ireland
- Netherlands
- Switzerlandprice
- United Kingdom
The record
At a glance
HPRA (Ireland)- Active substance
- Hexetidine
- Manufacturer
- JNTL Consumer Health I (Ireland) Limited
- Country
- Ireland (IE)
- ATC code
- A01AB12
- ATC class
- Hexetidine
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberPA23490/009/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Hexetidine in 7 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SwitzerlandDrossadin
- FranceHEXETIDINE BIOGARAN CONSEIL 0,1 %, solution pour bain de boucheBIOGARAN
- GermanyHexoralKenvue Germany Gmbh
- BelgiumHextril 0.1 %Kenvue Belgium
- CzechiaSTOPANGINTeva B.V., Haarlem
- United KingdomOraldene 0.1% mouthwash peppermintMcNeil Products Ltd
- NetherlandsHextril 1 mg/ml, mondspoelingKenvue Netherlands B.V.
Authorised across Europe · EMA
The same active substance is authorised in 17 EEA countries. Names it is sold under:
- Austria · Hexoral
- Belgium · Hextril
- Cyprus · Hexalen
- Czechia · Stopangin
- Germany · Hexoral, Vagi-Hex
- Estonia · Hexoral
- France · Hexetidine Biogaran Conseil, Hexetidine Eg Labo Conseil
- United Kingdom (Northern Ireland) · Oraldene, Oraldene Icemint
- Greece · Hexalen
- Croatia · Belosept, Hexoral
- Luxembourg · Hextril
- Latvia · Hexoral
- Malta · Oraldene
- Netherlands · Hextril
- Portugal · Collu-Hextril, Hextril
- Romania · Hexoral
- Slovakia · Stopangin
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/1a659395-7605-4fa0-beee-409c0ac6531e GET /v1/drugs/1a659395-7605-4fa0-beee-409c0ac6531e?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": "Gargle/mouthwash",
"routes": [
"Oromucosal use"
],
"source": "hpra",
"atc_all": [
"A01AB",
"A01AB12"
],
"strength": null,
"pa_number": "PA23490/009/001",
"substances": [
"Hexetidine"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Marketed",
"authorised_at": "26/03/1990",
"dispensing_status": "Product not subject to medical prescription",
"registration_status": "AU",
"supply_legal_status": "Supply through non-pharmacy outlets and pharmacies",
"interchangeable_code": null
}See everything about hexetidine.
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.