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United States· US:36800-505_285fde8b-8485-b050-e063-6294a90a0dab

Sinus Congestion and Pain Severe

A medicinal product containing guaifenesin; phenylephrine hydrochloride; acetaminophen, registered in United States by TopCare.

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…normalisedSinus Congestion and Pain SevereATC—REGISTER NO.US:36800-505_285fde8b…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN
Manufacturer
TopCare
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

  • ndc11
    3680050505
    2 BLISTER PACK in 1 CARTON (36800-505-05) / 12 TABLET, COATED in 1 BLISTER PACK
  • ndc11
    36800-505-05

Regulatory notes

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

Same medicine, other countries

Guaifenesin; phenylephrine hydrochloride; acetaminophen in 6 other countries

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

All guaifenesin; phenylephrine hydrochloride; acetaminophen products

Authorised across Europe · EMA

The same active substance is authorised in 20 EEA countries. Names it is sold under:

  • Austria · Influbene Erkältungsgetränk
  • Bulgaria · Vicks Antigrip Complex, Адипамол Антитусив
  • Cyprus · Panadol Cold & Flu & Cough, Solpadeine Cold & Flu
  • Czechia · Coldrex Na Vlhký Kašel, Panadol Chřipka A Kašel
  • Germany · Daymed Kombi Erkältungsgetränk, Otricomplex Erkältungskapseln
  • Estonia · Coldrex Hotex, Coldrex Maxgrip
  • Spain · Bronchogrip, Ilvigrip
  • United Kingdom (Northern Ireland) · All In One Max Strength Cold & Flu Capsules, All In One Max Strength Cold & Flu Relief
  • Greece · Bronchogrip, Panadol Cold & Flu & Cough
  • Croatia · Coldrex Combogrip, Lupocet Trio
  • Hungary · Coldrex Plus Köhögés, Coldrex Plus Köhögés Elleni
  • Ireland · Lemsip Multi-Relief, Paracetamol, Guaifenesin, Phenylephrine Hydrochloride Wick Pharma
  • Italy · Bronchenolo Tosse, Influenza E Raffreddore, Vicks Flu Tripla Azione
  • Lithuania · Hotex, Paracetamolum/Guaifenesinum/Phenylephrini Hydrochloridum Richard Bittner Ag
  • Latvia · Colcaps, Hotex
  • Poland · Coldrex Complex Grip, Gripex Pro Mucus
  • Portugal · Antigrippine Trieffect Tosse, Panadol Gripus
  • Romania · Coldrex Junior, Coldrex Max Răceală Și Tuse
  • Slovenia · Belucet, Combocoldrex
  • Slovakia · Coldrex Grip Plus Kašeľ, Coldrex Grip Plus Kašeľ S Príchuťou Citrónu A Mentolu

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/ad79775d-88de-4a95-8494-a76da83276e1
GET /v1/drugs/ad79775d-88de-4a95-8494-a76da83276e1?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; 5; 325",
  "substance": "GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN",
  "productndc": "36800-505",
  "dosage_form": "TABLET, COATED",
  "dea_schedule": null,
  "strength_unit": "mg/1; mg/1; mg/1",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG"
}

See everything about guaifenesin; phenylephrine 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.