Back to search

United States· US:58602-824_3ff696ea-da6c-4fc6-8cff-9681519ed78d

Guaifenesin and Dextromethorphan HBr

A medicinal product containing guaifenesin; dextromethorphan hydrobromide, 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…normalisedGuaifenesin and Dextromethorphan HBrATC—REGISTER NO.US:58602-824_3ff696ea…PACKS LISTED4CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
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 · 4

  • ndc11
    5860282408
    4 BLISTER PACK in 1 CARTON (58602-824-08) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • ndc11
    5860282467
    2 BLISTER PACK in 1 CARTON (58602-824-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • ndc11
    58602-824-08
  • ndc11
    58602-824-67

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/b3843176-a2c9-45d7-8243-1207afbf857f
GET /v1/drugs/b3843176-a2c9-45d7-8243-1207afbf857f?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": "600; 30",
  "substance": "GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE",
  "productndc": "58602-824",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "dea_schedule": null,
  "strength_unit": "mg/1; mg/1",
  "application_number": "ANDA206941",
  "marketing_category": "ANDA"
}

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.