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United States· US:53041-618_2bf14ba7-0b95-484f-bdee-d831f1f0cbe1

Tussnex FM Cold, Flu and Sore Throat

A medicinal product containing acetaminophen; dextromethorphan hydrobromide; guaifenesin; phenylephrine hydrochloride, registered in United States by Guardian Drug Company.

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…normalisedTussnex FM Cold, Flu and Sore ThroatATC—REGISTER NO.US:53041-618_2bf14ba7…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Manufacturer
Guardian Drug Company
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
    5304161858
    177 mL in 1 CARTON (53041-618-58)
  • ndc11
    53041-618-58

Regulatory notes

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

Same medicine, other countries

Acetaminophen; dextromethorphan hydrobromide; guaifenesin; phenylephrine hydrochloride in 1 other country

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

All acetaminophen; dextromethorphan hydrobromide; guaifenesin; phenylephrine hydrochloride products

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/020cb93e-4a60-46c9-a1cf-26657617f996
GET /v1/drugs/020cb93e-4a60-46c9-a1cf-26657617f996?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": "650; 20; 400; 10",
  "substance": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
  "productndc": "53041-618",
  "dosage_form": "LIQUID",
  "dea_schedule": null,
  "strength_unit": "mg/20mL; mg/20mL; mg/20mL; mg/20mL",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG"
}

See everything about acetaminophen; dextromethorphan hydrobromide; guaifenesin; phenylephrine 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.