Poland· PL-100065597

Tantum Rosa

A benzydamine product containing benzydamini hydrochloridum, registered in Poland by Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.. The same ATC class is registered in 2 of our 19 countries.

ATC G02CC03

Checked against URPL (Poland) on

Informational only — not a medical device.

SOURCE REGISTER · PLURPL (Poland)normalisedTantum RosaATCG02CC03REGISTER NO.PL-100065597PACKS LISTED3CHECKEDSeptember 27, 2026

Where it is registered

Benzydamine is registered in 2 of 19 countries.

Countries holding a registration under ATC G02CC03 (benzydamine), each read from that country’s own register.

  • This record: Poland, from URPL (Poland)
  • 2 of them publish a price we can compare per daily dose

Benzydamine · ATC G02CC03

2 / 19 countries

  • Czechiaprice
  • Polandprice
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

URPL (Poland)
Active substance
Benzydamini hydrochloridum
Manufacturer
Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.
Country
Poland (PL)
ATC code
G02CC03
ATC class
Benzydamine
Reimbursed
Not published by this register
Source register
URPL (Poland)
Last checked
September 27, 2026

Packs & prices · 3

  • gtin
    05909990027811
  • gtin
    05909990027828
  • gtin
    05909990762583

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Benzydamine in 12 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 27 EEA countries. Names it is sold under:

  • Austria · Benzydamin Angelini, Biramine
  • Belgium · Orocalm, Orocalm Citroensmaak
  • Bulgaria · Бензидамин Анджелини, Нео-Ангин neo-Angin
  • Cyprus · Difflam, Soril Throat Spray
  • Czechia · Belozyme, Galverde
  • Germany · Difflam, Neo-Angin
  • Denmark · Andolex, Bertolix
  • Spain · Dracosan, Fodonal
  • Finland · Bertolix, Zysils Appelsiini-Hunaja
  • France · Benzydamine Sans Sucre, Édulcorée À La Saccharine Sodique Urgo, Humex
  • United Kingdom (Northern Ireland) · Benzydamine Focus Pharmaceuticals, Benzydamine Focus Pharmaceuticals Ltd
  • Greece · Fenzyvag, Tantum Verde
  • Croatia · Neobenzela S Okusom Limuna, Tantum Verde
  • Hungary · Benzidamin-Hidroklorid Angelini, Lolisept
  • Ireland · Difflam, Difflam Oral Rinse
  • Italy · Afloben, Benzidamina Acraf
  • Lithuania · Gerlen, Tantum Lemon
  • Luxembourg · Orocalm Goût Citron, Orocalm Goût Miel Et Orange
  • Latvia · Nova Verde
  • Malta · Difflam, Tantum Verde
  • Netherlands · Tantum
  • Norway · Benzydaminhydroklorid Geiser, Bertolix
  • Portugal · Flogoral, Momen
  • Romania · Benzidamina Geiser Pharma, Benzidamină Geiser Pharma
  • Sweden · Andolex, Bensydamin Geiser
  • Slovenia · Tantum Verde, Tantum Verde Z Okusom Limone
  • Slovakia · Garganta, Garganta Forte

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 URPL (Poland). 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/c236c369-da70-4416-997a-89b960ffeb99
GET /v1/drugs/c236c369-da70-4416-997a-89b960ffeb99?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": "Proszek do sporządzania roztworu dopochwowego",
  "source": "urpl",
  "strength": "53,2 mg/g",
  "packaging": "05909990027811 ¦ OTC ¦ Skasowane ¦ 9868\n5 sasz. \n05909990027828 ¦ OTC ¦ 9870\n10 sasz. \n05909990762583 ¦ OTC ¦ 56153\n6 sasz.",
  "substance": "Benzydamini hydrochloridum 0.5 g",
  "common_name": "Benzydamini hydrochloridum",
  "pl_product_id": "100065597",
  "pozwolenie_nr": "00278",
  "auth_procedure": "NAR",
  "authorisation_validity": "Bezterminowe"
}

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.