United States· US:50580-436_2ffbcc44-0ef3-b149-e063-6394a90ae7f5
Sudafed PE Head Congestion Plus Pain
A medicinal product containing ibuprofen; phenylephrine hydrochloride, registered in United States by Kenvue Brands LLC.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE
- Manufacturer
- Kenvue Brands LLC
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc1150580436012 BLISTER PACK in 1 CARTON (50580-436-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK
- ndc1150580-436-01
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Ibuprofen; phenylephrine hydrochloride in 5 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomLemsip Max All Night Cold & Flu tabletsReckitt Benckiser Healthcare (UK) Ltd
- SpainGRIPPOSTAD CON IBUPROFENO 200 MG/5 MG COMPRIMIDOS RECUBIERTOS CON PELICULALaboratorio Stada S.L.
- PolandAcatar Zatoki TabsUS Pharmacia Sp. z o.o.
- CzechiaMODINZASTADA Arzneimittel AG, Bad Vilbel
- GermanyIbuprofen/Phenylephrin StadaStada Consumer Health Deutschland Gmbh
Authorised across Europe · EMA
The same active substance is authorised in 11 EEA countries. Names it is sold under:
- Austria · Ibufix
- Bulgaria · Ибупром Настинка И Грип, Ибупрофен Стопколд
- Czechia · Ibuprofen/Phenylephrine Opella
- Germany · Ibuprofen/Phenylephrin Stada
- Spain · Ibuprofeno/Fenilefrina Nutra Essential
- United Kingdom (Northern Ireland) · Care, Nurofen Sinus & Blocked Nose
- Croatia · Ibufix, Ibufix Forte Stada
- Lithuania · Ibusin
- Poland · Acatar Zatoki Tabs, Ibuprom Zatoki Tabs
- Portugal · Grippostad
- Slovakia · Ibuprofenum/Phenylephrine Stada
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 FDA National Drug Code directory (United States). 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/07878430-c0f1-4f21-979b-8ae30b62b695 GET /v1/drugs/07878430-c0f1-4f21-979b-8ae30b62b695?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.
{
"route": "ORAL",
"source": "ndc",
"strength": "200; 10",
"substance": "IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE",
"productndc": "50580-436",
"dosage_form": "TABLET, FILM COATED",
"dea_schedule": null,
"strength_unit": "mg/1; mg/1",
"application_number": "ANDA203200",
"marketing_category": "ANDA"
}See everything about ibuprofen; phenylephrine hydrochloride.
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.