United States· US:12539-555_463c3f95-ed8f-ee88-e063-6394a90a54f5

NeoTuss S/F

A medicinal product containing guaifenesin; dextromethorphan hydrobromide, registered in United States by DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals.

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…normalisedNeoTuss S/FATC—REGISTER NO.US:12539-555_463c3f95…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Manufacturer
DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals
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
    1253955516
    474 mL in 1 BOTTLE (12539-555-16)
  • ndc11
    12539-555-16

Regulatory notes

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

Same medicine, other countries

Guaifenesin; dextromethorphan hydrobromide in 2 other countries

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

All guaifenesin; dextromethorphan hydrobromide 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/bcc91683-2dc6-4a71-b13d-27210969defa
GET /v1/drugs/bcc91683-2dc6-4a71-b13d-27210969defa?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": "GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE",
  "productndc": "12539-555",
  "dosage_form": "LIQUID",
  "dea_schedule": null,
  "strength_unit": "mg/5mL; mg/5mL",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG"
}

See everything about guaifenesin; dextromethorphan hydrobromide.

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.