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United States· US:82568-0014_5460ca0d-f6b3-423d-e063-6294a90afce7

Tussin DM Regular

A medicinal product containing dextromethorphan hydrobromide; guaifenesin, registered in United States by AARNA USA, Inc..

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

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedTussin DM RegularATC—REGISTER NO.US:82568-0014_5460ca0…PACKS LISTED3CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Manufacturer
AARNA USA, Inc.
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 · 3

  • ndc11
    82568-0014-4
  • ndc11
    82568-0014-6
  • ndc11
    82568-0014-8

Regulatory notes

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

Same medicine, other countries

Dextromethorphan hydrobromide; guaifenesin in 2 other countries

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

All dextromethorphan hydrobromide; guaifenesin products

Authorised across Europe · EMA

The same active substance is authorised in 2 EEA countries. Names it is sold under:

  • Spain · Broncomedical Con Guaifenesina, Cinfatós Expectorante
  • Italy · Bronchenolo Sedativo E Fluidificante, Bronchenolo Sedativo E Fluidificante Gusto Menta

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/b3e41d92-e309-4f8c-a776-fbdd32b022d6
GET /v1/drugs/b3e41d92-e309-4f8c-a776-fbdd32b022d6?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": "20; 200",
  "substance": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
  "productndc": "82568-0014",
  "dosage_form": "LIQUID",
  "dea_schedule": null,
  "strength_unit": "mg/10mL; mg/10mL",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG"
}

See everything about dextromethorphan hydrobromide; guaifenesin.

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.