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Belgium· BE-AMP-SAM531840-00

Orocalm Forte 3 mg/ml

A benzydamine product containing benzydamine hydrochloride, registered in Belgium by Melisana. The same ATC class is registered in 8 of our 19 countries.

ATC R02AX03

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedOrocalm Forte 3 mg/mlATCR02AX03REGISTER NO.BE-AMP-SAM531840-00PACKS LISTED0CHECKEDSeptember 26, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about benzydamine hydrochlorideAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

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: Belgium, from FAMHP / AFMPS (Belgium)
  • 7 of them publish a price we can compare per daily dose
Search benzydamine products by name

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

FAMHP / AFMPS (Belgium)
Active substance
Benzydamine Hydrochloride
Manufacturer
Melisana
Country
Belgium (BE)
ATC code
R02AX03
ATC class
Benzydamine
Defined daily dose
9 mg, O
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 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 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
  • 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
  • Poland · Actusept, Benzydamine Neo-Angin
  • 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 FAMHP / AFMPS (Belgium). 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/d26309f7-5eb3-44bd-ae04-ec8671853a33
GET /v1/drugs/d26309f7-5eb3-44bd-ae04-ec8671853a33?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": "Oromucosal spray, solution",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Orocalm Forte 3 mg/ml",
  "name_fr": "Orocalm Forte 3 mg/ml",
  "name_nl": "Orocalm Forte 3 mg/ml",
  "amp_code": "SAM531840-00",
  "strengths": [
    "3.0000",
    "81.0000",
    "50.0000",
    "0.5000",
    "1.0000"
  ],
  "pack_count": 2,
  "substances": [
    "Benzydamine Hydrochloride",
    "Ethanol 96%",
    "Glycerol 85%",
    "Methyl Parahydroxybenzoate",
    "Saccharin Sodium",
    "Sodium Hydrogen Carbonate"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Benzydamine",
  "authorisation_numbers": [
    "BE531840"
  ]
}
API referenceMCP serverPlans

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.

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