Germany· DE-A57-b27397c82a32e1c2
Betolo
A medicinal product containing lidocaine hydrochloride monohydrate, amylmetacresol, 2,4 dichlorobenzyl alcohol, registered in Germany by Geiser Pharma, S.L.
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
- Lidocaine Hydrochloride Monohydrate, Amylmetacresol, 2,4 Dichlorobenzyl Alcohol
- Manufacturer
- Geiser Pharma, S.L
- 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
Lidocaine hydrochloride monohydrate, amylmetacresol, 2,4 dichlorobenzyl alcohol in 8 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaASPEGOLABAYER s.r.o., Praha
- FranceAMYLMETACRESOL/ALCOOL DICHLOROBENZYLIQUE/LIDOCAINE BIOGARAN CONSEIL 223 mg/ 446 mg/ 600 mg, solution pour pulvérisation buccaleBIOGARAN
- SpainBUCOMAX CON LIDOCAINA PASTILLAS PARA CHUPAR SABOR MENTALaboratorios Cinfa S.A.
- PolandASPIGOLA smak miętowy bez cukruBayer Sp. z o.o.
- FinlandBetoloFennogate Finland Oy
- NorwayMint-ClonidineMint Pharmaceuticals
- SwedenBetolo apelsin SugtablettGeiser Pharma, S.L.
- IrelandStrepsils +Plus Anaesthetic Lozenges Amylmetacresol 0.6mg 2,4-Dichlorobenzyl Alcohol 1.2mg Lidocaine Hydrochloride 10mgReckitt Benckiser Ireland Ltd
Authorised across Europe · EMA
The same active substance is authorised in 21 EEA countries. Names it is sold under:
- Belgium · Collutabs Goût Menthe, Collutabs Goût Miel Et Citron
- Bulgaria · Аспи-Ангин, Иновокс Експрес С Вкус На Мед И Лимон
- Cyprus · Soril-Med Orange
- Czechia · Aspegola, Aspegola Máta
- Denmark · Betolo, Betolo Appelsin
- Spain · Bucomax Con Sabor Menta, Bucomax Con Sabor Miel Y Limón
- Finland · Betolo, Lidomax Appelsiini
- France · Amylmetacresol/Alcool Dichlorobenzylique/Lidocaine Biogaran Conseil, Humex Mal De Gorge Menthe
- United Kingdom (Northern Ireland) · Chloralieve Blackcurrant Flavour, Chloralieve Honey & Lemon Flavour
- Greece · Strepsils Plus
- Croatia · Strepsils Plus
- Hungary · Aspegola Méz-Citrom Ízű Cukormentes, Strepsils Plus
- Ireland · Strepsils +plus Anaesthetic, Strepsils +plus Anaesthetic Throat
- Lithuania · Inovox Honey Lemon, Inovox Menthol
- Luxembourg · Collutabs Goût Menthe, Collutabs Goût Miel Et Citron
- Netherlands · Amylmetacresol Dichloorbenzylalcohol Lidocaïne Hcl Linn, Bogasan Mint
- Norway · Betolo, Betolo Med Appelsinsmak
- Poland · Aspigola, Aspigola Smak Mietowy Bez Cukru
- Romania · Aspigola, Aspigola Mentă
- Sweden · Betolo, Betolo Apelsin
- Slovakia · Aspegola, Orasept Plus
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/9a06122b-19a2-4e91-85a0-296717ccb789 GET /v1/drugs/9a06122b-19a2-4e91-85a0-296717ccb789?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": "Oromucosal Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Lidocaine Hydrochloride Monohydrate, Amylmetacresol, 2,4 Dichlorobenzyl Alcohol",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about lidocaine hydrochloride monohydrate, amylmetacresol, 2,4 dichlorobenzyl alcohol.
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.