United States· US:50580-344_21702ebc-459b-7f5a-e063-6294a90ad432
Extra Strength TYLENOL Cold Plus Flu Multi-Action
A medicinal product containing dextromethorphan hydrobromide; acetaminophen; pseudoephedrine 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
- DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; PSEUDOEPHEDRINE 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
- ndc1150580344012 BLISTER PACK in 1 CARTON (50580-344-01) / 12 TABLET, FILM COATED in 1 BLISTER PACK
- ndc1150580-344-01
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Dextromethorphan hydrobromide; acetaminophen; pseudoephedrine hydrochloride in 5 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- PolandGripex MaxUS Pharmacia Sp. z o.o.
- CanadaBUCKLEY'S COMPLETE EXTRA STRENGTH COUGH, COLD & FLU DAYHALEON CANADA ULC
- CzechiaPARALEN PLUSOpella Healthcare Czech s.r.o., Praha
- SpainPHARMAGRIP TOS Y CONGESTIÓN POLVO PARA SOLUCION ORALLaboratorios Cinfa S.A.
- SwitzerlandPretuval Grippe & Erkältung, FilmtablettenBayer (Schweiz) AG
Authorised across Europe · EMA
The same active substance is authorised in 12 EEA countries. Names it is sold under:
- Bulgaria · Грипекс, Грипекс Макс
- Czechia · Paralen Plus
- Estonia · Theraflu Nd
- Spain · Pharmagrip Tos Y Congestión
- Croatia · Daleron Cold
- Lithuania · Daleron Cold3, Gripex
- Latvia · Colmed, Daleron Cold3
- Malta · Daleron Cold3
- Poland · Agrypin, Gripblocker Express
- Romania · Bioflu, Bioflu Junior
- Slovenia · Daleron Cold3
- Slovakia · Daleron Cold 3, Paralen Grip
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/dacb67d9-faaa-436c-bd05-3bb874f3da49 GET /v1/drugs/dacb67d9-faaa-436c-bd05-3bb874f3da49?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": "15; 500; 30",
"substance": "DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"productndc": "50580-344",
"dosage_form": "TABLET, FILM COATED",
"dea_schedule": null,
"strength_unit": "mg/1; mg/1; mg/1",
"application_number": "M012",
"marketing_category": "OTC MONOGRAPH DRUG"
}See everything about dextromethorphan hydrobromide; acetaminophen; pseudoephedrine 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.