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United States· US:50580-659_537e1a0d-820e-c3f7-e063-6294a90a56ea

Sudafed Sinus Congestion Plus Cold Severe Day

A medicinal product containing pseudoephedrine hydrochloride; acetaminophen, registered in United States by Kenvue Brands LLC.

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedSudafed Sinus Congestion Plus Cold Se…ATC—REGISTER NO.US:50580-659_537e1a0d…PACKS LISTED1CHECKEDSeptember 27, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about pseudoephedrine hydrochloride; acetaminophenAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
PSEUDOEPHEDRINE HYDROCHLORIDE; ACETAMINOPHEN
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 · 1

  • ndc11
    50580-659-10

Regulatory notes

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

Same medicine, other countries

Pseudoephedrine hydrochloride; acetaminophen in 9 other countries

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

All pseudoephedrine hydrochloride; acetaminophen products

Authorised across Europe · EMA

The same active substance is authorised in 18 EEA countries. Names it is sold under:

  • Belgium · Paracetamol/ Pseudoephedrine Upsa, Paracetamol/Pseudoephedrine Upsa
  • Cyprus · Panadol Cold & Flu
  • Germany · Theraflu Erkältung Heißgetränk
  • Estonia · Theraflu Sn
  • Spain · Termalgin Resfriado
  • France · Dolirhume, Rhumagrip
  • United Kingdom (Northern Ireland) · Contac, Day Nurse
  • Greece · Comtrex Cold Day, Panadol Cold & Flu
  • Hungary · Neo Citran Cold And Sinus
  • Ireland · Lemsip Max Sinus & Flu Hot Lemon, Non-Drowsy Sinutab
  • Italy · Efferalgan Febbre E Congestione Nasale, Fluimucil Influenza E Raffreddore
  • Lithuania · Theraflu Sn
  • Luxembourg · Paracetamol/Pseudoephedrine Upsa, Sinutab
  • Latvia · Theraflu Sn
  • Malta · Panadol Cold & Flu
  • Poland · Gripblocker Zatoki, Zatoxin Fast
  • Portugal · Algik Gripe, Holsigrip
  • Romania · Bioflu Sinus, Coldact Sinus

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/0bc553b6-9dee-4057-b5cb-8333e87558f5
GET /v1/drugs/0bc553b6-9dee-4057-b5cb-8333e87558f5?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": "30; 500",
  "substance": "PSEUDOEPHEDRINE HYDROCHLORIDE; ACETAMINOPHEN",
  "productndc": "50580-659",
  "dosage_form": "TABLET, FILM COATED",
  "dea_schedule": null,
  "strength_unit": "mg/1; mg/1",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG"
}
API referenceMCP serverPlans

See everything about pseudoephedrine hydrochloride; acetaminophen.

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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