Germany· DE-A57-a6432390e32d0783
Octenisept
A medicinal product containing octenidine dihydrochloride, phenoxyethanol, registered in Germany by Schülke & Mayr Gmbh.
Checked against EMA Article 57 (European Union) on
Informational only — not a medical device.
The record
At a glance
EMA Article 57 (European Union)- Active substance
- Octenidine Dihydrochloride, Phenoxyethanol
- Manufacturer
- Schülke & Mayr Gmbh
- Country
- Germany (DE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- EMA Article 57 (European Union)
- Last checked
- July 8, 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
Octenidine dihydrochloride, phenoxyethanol in 2 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
Authorised across Europe · EMA
The same active substance is authorised in 17 EEA countries. Names it is sold under:
- Austria · Betaoctine, Linola Sept
- Bulgaria · Октекеър, Симплисепт
- Cyprus · Octiset
- Czechia · Octenisept, Octicide
- Estonia · Octenisept, Octicide
- Greece · Betaoctine, Octenisept
- Croatia · Octenisept
- Hungary · Octenisept, Octicide
- Lithuania · Duoseptic, Fenocty
- Luxembourg · Octenisept
- Latvia · Octenisept, Octezy
- Malta · Octenisept
- Poland · Actisept Med, Dichlorowodorek Oktenidyny + Fenoksyetanol Lavipharm
- Portugal · Octiset
- Romania · Betaoctine®, Octenisept
- Slovenia · Ofenosept
- Slovakia · Octenisept, Octicide
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 EMA Article 57 (European Union). 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/f8cd1749-fe5c-4f3c-9c9b-5fee86c08592 GET /v1/drugs/f8cd1749-fe5c-4f3c-9c9b-5fee86c08592?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.
{
"pzn": null,
"route": "Cutaneous Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Octenidine Dihydrochloride, Phenoxyethanol",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about octenidine dihydrochloride, phenoxyethanol.
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.