Ireland· IE-PA-PA1113/021/001
Dentinox Infant Colic Drops 21 mg/2.5 ml Oral Suspension
A silikone product containing dimeticone, activated, registered in Ireland by Phoenix Labs. The same ATC class is registered in 10 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Silikone is registered in 10 of 19 countries.
Countries holding a registration under ATC A03AX13 (silikone), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 7 of them publish a price we can compare per daily dose
Silikone · ATC A03AX13
10 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Norwayprice
- Polandprice
- Switzerlandprice
Price per daily dose
What a daily dose of silikone costs, country by country.
Normalised to the WHO defined daily dose (0.5 g), so markets compare like for like.
- 1 market with a comparable price for this class
- Public list prices, converted to USD at the rate date shown
Silikone · price per daily dose (0.5 g)
USD · FX 28 Sept 2026
- CH Switzerland$2.54
The record
At a glance
HPRA (Ireland)- Active substance
- Dimeticone, activated
- Manufacturer
- Phoenix Labs
- Country
- Ireland (IE)
- ATC code
- A03AX13
- ATC class
- Silikone
- Defined daily dose
- 0.5 g, O
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberPA1113/021/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same class
Other records under A03AX13
Silikone, as other registers publish it.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of HPRA (Ireland). 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/86f5c703-e4c3-4382-a15f-e2e187eee878 GET /v1/drugs/86f5c703-e4c3-4382-a15f-e2e187eee878?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": "Oral suspension",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"A03AX",
"A03AX13"
],
"strength": null,
"pa_number": "PA1113/021/001",
"substances": [
"Dimeticone, activated"
],
"legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)",
"market_info": "Marketed",
"authorised_at": "05/10/1983",
"dispensing_status": "Product not subject to medical prescription",
"registration_status": "AU",
"supply_legal_status": "Supply through non-pharmacy outlets and pharmacies",
"interchangeable_code": null
}See everything about silikone.
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.