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United States· US:58602-803_08c50304-67d6-4733-84e4-5a686afa04f3

Ibuprofen and Pseudoephedrine HCl

A medicinal product containing ibuprofen; pseudoephedrine hydrochloride, registered in United States by Aurohealth 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…normalisedIbuprofen and Pseudoephedrine HClATC—REGISTER NO.US:58602-803_08c50304…PACKS LISTED8CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Manufacturer
Aurohealth 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
    5860280303
    1 BLISTER PACK in 1 CARTON (58602-803-03) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58602-803-83)
  • ndc11
    5860280308
    4 BLISTER PACK in 1 CARTON (58602-803-08) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58602-803-83)
  • ndc11
    5860280313
    4 BLISTER PACK in 1 CARTON (58602-803-13) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58602-803-79)
  • ndc11
    5860280367
    2 BLISTER PACK in 1 CARTON (58602-803-67) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58602-803-83)
  • ndc11
    58602-803-03
  • ndc11
    58602-803-08
  • ndc11
    58602-803-13
  • ndc11
    58602-803-67

Regulatory notes

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

Same medicine, other countries

Ibuprofen; pseudoephedrine hydrochloride in 9 other countries

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

All ibuprofen; pseudoephedrine hydrochloride products

Authorised across Europe · EMA

The same active substance is authorised in 23 EEA countries. Names it is sold under:

  • Austria · Boxagrippal, Boxagrippal Erkältungssaft
  • Belgium · Sinuphene
  • Bulgaria · Ибупром Синус, Ибупром Синус Макс
  • Cyprus · Nurofen Cold & Flu
  • Czechia · Grippecton, Modafen
  • Germany · Boxagrippal Erkältungssaft, Boxagrippal Erkältungstabletten
  • Estonia · Febrilek, Tonufen
  • Spain · Ibuprofeno/Pseudoefedrina Nutra Essential, Ilvisinus
  • France · Nurofen Rhume, Rhinadvil Rhume
  • United Kingdom (Northern Ireland) · Ibuprofen And Pseudoephedrine Hydrochloride Farmalider, Nurofen Sinus Pressure & Headache Relief
  • Greece · Gripomed, Nurofen Cold And Flu
  • Croatia · Nurofen Cold And Flu
  • Hungary · Advil Cold, Advil Cold Rapid
  • Ireland · Advil Cold & Flu, Advil Cold & Flu Relief
  • Italy · Actisinu, Aislar
  • Lithuania · Daikol, Iloxen
  • Luxembourg · Sinuphene
  • Latvia · Iloxen, Nurofen Antigrip
  • Malta · Advil Cold & Flu, Nurofen Cold & Flu
  • Poland · Acatar Zatoki, Apselan Plus
  • Portugal · Cêgrifen, Grinhals
  • Romania · Biofen Raceala Si Gripa, Ibugrip Plus
  • Slovakia · Modafen, Nurofen Stopgrip

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/01ff98f6-b302-4c40-868f-8e9737f19897
GET /v1/drugs/01ff98f6-b302-4c40-868f-8e9737f19897?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; 30",
  "substance": "IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE",
  "productndc": "58602-803",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "dea_schedule": null,
  "strength_unit": "mg/1; mg/1",
  "application_number": "ANDA209235",
  "marketing_category": "ANDA"
}

See everything about ibuprofen; 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.