Poland· PL-100108450

Otrivin Allergy

A phenylephrin, kombinationen product containing phenylephrinum + dimetindeni maleas, registered in Poland by Haleon Poland Sp. z o.o.. The same ATC class is registered in 2 of our 19 countries.

ATC R01BA53

Checked against URPL (Poland) on

Informational only — not a medical device.

SOURCE REGISTER · PLURPL (Poland)normalisedOtrivin AllergyATCR01BA53REGISTER NO.PL-100108450PACKS LISTED2CHECKEDSeptember 27, 2026

Where it is registered

Phenylephrin, kombinationen is registered in 2 of 19 countries.

Countries holding a registration under ATC R01BA53 (phenylephrin, kombinationen), 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

Phenylephrin, kombinationen · ATC R01BA53

2 / 19 countries

  • 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

URPL (Poland)
Active substance
Phenylephrinum + Dimetindeni maleas
Manufacturer
Haleon Poland Sp. z o.o.
Country
Poland (PL)
ATC code
R01BA53
ATC class
Phenylephrin, Kombinationen
Reimbursed
Not published by this register
Source register
URPL (Poland)
Last checked
September 27, 2026

Packs & prices · 2

  • gtin
    05909990942213
  • gtin
    05909990942220

Regulatory notes

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

Same medicine, other countries

Phenylephrin, kombinationen in 2 other countries

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

All phenylephrin, kombinationen products

Authorised across Europe · EMA

The same active substance is authorised in 13 EEA countries. Names it is sold under:

  • Austria · Vibrocil
  • Belgium · Vibrocil
  • Bulgaria · Виброцил
  • Czechia · Vibrocil
  • Greece · Otrhinitis
  • Hungary · Otrivin Allergia, Vibrocil
  • Lithuania · Vibrocil
  • Luxembourg · Vibrocil
  • Latvia · Vibrocil
  • Malta · Vibrocil
  • Portugal · Vibrocil
  • Romania · Vibrocil, Vibrocil Copii
  • Slovakia · Vibrocil

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/5d4aeb2a-f003-49d1-88de-3dff49e0c715
GET /v1/drugs/5d4aeb2a-f003-49d1-88de-3dff49e0c715?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": "Aerozol do nosa, roztwór",
  "source": "urpl",
  "strength": "(2,5 mg + 0,25 mg)/ml",
  "packaging": "05909990942213 ¦ OTC ¦ Skasowane ¦ 19346\n1 butelka 10 ml\n05909990942220 ¦ OTC ¦ 21037\n1 butelka 15 ml",
  "substance": "Phenylephrinum 0.25 % + Dimetindeni maleas 25 %",
  "common_name": "Phenylephrinum + Dimetindeni maleas",
  "pl_product_id": "100108450",
  "pozwolenie_nr": "09422",
  "auth_procedure": "NAR",
  "authorisation_validity": "Bezterminowe"
}

See everything about phenylephrin, kombinationen.

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.