Iceland· IS-IS/1/25/087/01

Septabene cola

A benzydamine product containing benzydaminum inn hýdróklóríð,cetylpyridinium chloride,cetylpyridinium chloride monohydrate, registered in Iceland by KRKA tovarna zdravil d.d. Novo mesto. The same ATC class is registered in 8 of our 19 countries.

ATC R02AX03

Checked against Icelandic Medicines Agency (Iceland) on

Informational only — not a medical device.

SOURCE REGISTER · ISIcelandic Medicines Agency (Iceland)normalisedSeptabene colaATCR02AX03REGISTER NO.IS-IS/1/25/087/01PACKS LISTED0CHECKEDSeptember 29, 2026

Where it is registered

Benzydamine is registered in 8 of 19 countries.

Countries holding a registration under ATC R02AX03 (benzydamine), each read from that country’s own register.

  • This record: Iceland, from Icelandic Medicines Agency (Iceland)
  • 7 of them publish a price we can compare per daily dose

Benzydamine · ATC R02AX03

8 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Norwayprice
  • Polandprice
  • Switzerlandprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

Icelandic Medicines Agency (Iceland)
Active substance
Benzydaminum INN hýdróklóríð,Cetylpyridinium chloride,Cetylpyridinium chloride monohydrate
Manufacturer
KRKA tovarna zdravil d.d. Novo mesto
Country
Iceland (IS)
ATC code
R02AX03
ATC class
Benzydamine
Defined daily dose
9 mg, O
Reimbursed
Not published by this register
Source register
Icelandic Medicines Agency (Iceland)
Last checked
September 29, 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

Benzydamine in 5 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All benzydamine products

Authorised across Europe · EMA

The same active substance is authorised in 22 EEA countries. Names it is sold under:

  • Austria · Tantum Verde Protect
  • Bulgaria · Септолете Тотал, Септолете Тотал Евкалипт
  • Cyprus · Bencet Mouth Spray
  • Czechia · Benzydamin/Cetylpyridinium Chlorid Krka, Benzydamin/Cetylpyridinium Chlorid Krka D.D.
  • Germany · Septolete, Septolete Mit Cola-Geschmack
  • Denmark · Septabene, Septabene Citron Og Honning
  • Estonia · Septolete Omni, Septolete Omni Eucalyptus
  • Spain · Septolete
  • Finland · Septabene, Septabene Cola
  • Greece · Bencet Mouth Spray
  • Croatia · Septolete Duo, Septolete Duo Eukaliptus
  • Hungary · Septolete Extra, Septolete Extra Citrom-Bodza
  • Ireland · Septabene, Septabene Eucalyptus
  • Italy · Gola Action, Gola Action Senza Zucchero
  • Lithuania · Benzydamine Hydrochloride/Cetylpyridinium Chloride Farmak, Septabene
  • Latvia · Septabene, Septabene Ar Citrona Un Ingvera Garšu
  • Malta · Septolete Total Cola, Septolete Total Eucalyptus
  • Poland · Septogard Plus, Septolete Core Smak Imbirowy
  • Portugal · Septolete Duo Cola, Septolete Duo Eucalipto
  • Romania · Septerloz Mentă, Septolete Omni
  • Slovenia · Septabene, Septabene Z Okusom Evkalipta
  • Slovakia · Septolete Extra, Septolete Extra Eukalyptus

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 Icelandic Medicines Agency (Iceland). 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/940ad001-15af-4bca-9232-77c036c85242
GET /v1/drugs/940ad001-15af-4bca-9232-77c036c85242?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": "Munnsogstafla",
  "source": "lyfjastofnun",
  "atc_raw": "R02AX03",
  "marketed": true,
  "strength": "3 mg/1 mg",
  "ma_number": "IS/1/25/087/01",
  "substance": "Benzydaminum INN hýdróklóríð,Cetylpyridinium chloride,Cetylpyridinium chloride monohydrate",
  "other_info": null,
  "legal_status": "(L) Ekki lyfseðilsskylt",
  "ma_issued_serial": "45833"
}

See everything about benzydamine.

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.