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United States· US:50580-208_48d075d6-52f3-6fd7-e063-6394a90ada71

Motrin Dual Action With Tylenol

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

US label

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

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedMotrin Dual Action With TylenolATC—REGISTER NO.US:50580-208_48d075d6…PACKS LISTED8CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
IBUPROFEN; 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 · 8

  • ndc11
    5058020802
    1 BOTTLE in 1 CARTON (50580-208-02) / 20 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5058020808
    1 BOTTLE in 1 CARTON (50580-208-08) / 80 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5058020812
    1 BOTTLE in 1 CARTON (50580-208-12) / 120 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5058020816
    2 CARTON in 1 CARTON (50580-208-16) / 1 BOTTLE in 1 CARTON / 80 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    50580-208-02
  • ndc11
    50580-208-08
  • ndc11
    50580-208-12
  • ndc11
    50580-208-16

Regulatory notes

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

Same medicine, other countries

Ibuprofen; acetaminophen in 14 other countries

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

All ibuprofen; acetaminophen products

Authorised across Europe · EMA

The same active substance is authorised in 30 EEA countries. Names it is sold under:

  • Austria · Combogesic, Comboval
  • Belgium · Brufen Plus Paracetamol, Combogesic
  • Bulgaria · Lekadol Complex, Nurulin Duo
  • Cyprus · Duomax, Edolfen Dual Action
  • Czechia · Brufen Combi, Cetalgen
  • Germany · Comboval, Duoval
  • Denmark · Comboval, Doleron
  • Estonia · Combogesic, Kivenul
  • Spain · Antidol Dual, Comboval
  • Finland · Comboval, Dolerin
  • France · Cetafen, Paracetamol/Ibuprofene Medipha
  • United Kingdom (Northern Ireland) · Combogesic, Combogesic Iv
  • Greece · Algofren Compositum, Combogesic
  • Croatia · Blokmax Duo, Brufen Akut Duo
  • Hungary · Advil Duo, Combogesic
  • Ireland · Combileve, Combileve 500 Mg/200 Mg Film-Coated Tablets
  • Iceland · Comboval, Paracetamol/Ibuprofen Vale Pharma
  • Italy · Combogesic, Paracetamolo E Ibuprofene Mylan
  • Lithuania · Adobil, Combogesic
  • Luxembourg · Brufen Plus Paracetamol, Combogesic
  • Latvia · Adobil, Combogesic
  • Malta · Combofusiv, Duomax
  • Netherlands · Comboval, Nuralgan
  • Norway · Comboval, Dolerin
  • Poland · 200 Mg + 500 Mg, Apap Intense
  • Portugal · Brufenon, Combofusiv
  • Romania · Advil Duo, Analgex
  • Sweden · Comboval, Dolerin
  • Slovenia · Adobil, Besta
  • Slovakia · Cetalgen, Combogesic

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/67a7469f-a0e6-46b4-a394-179609dcd14c
GET /v1/drugs/67a7469f-a0e6-46b4-a394-179609dcd14c?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": "125; 250",
  "substance": "IBUPROFEN; ACETAMINOPHEN",
  "productndc": "50580-208",
  "dosage_form": "TABLET, FILM COATED",
  "dea_schedule": null,
  "strength_unit": "mg/1; mg/1",
  "application_number": "ANDA214836",
  "marketing_category": "ANDA"
}

See everything about ibuprofen; 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.