United States· US:63304-110_801949ca-1baf-4a19-8466-91b4269a2c63
Guaifenesin and Dextromethorphan HBr
A medicinal product containing guaifenesin; dextromethorphan hydrobromide, registered in United States by SUN PHARMACEUTICAL INDUSTRIES, INC..
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES, 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 · 2
- ndc1163304-110-54
- ndc1163304110541 BLISTER PACK in 1 CARTON (63304-110-54) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
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.
- CanadaBENYLIN REGULAR STRENGTH COUGH PLUS CHEST CONGESTION RELIEFMCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC
- SpainBRONCOMEDICAL CON GUAIFENESINA 10 mg/100 mg SOLUCION ORALMedical S.A.
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/dda47b28-5cb9-43b4-9d5c-fd2899ffa2ff GET /v1/drugs/dda47b28-5cb9-43b4-9d5c-fd2899ffa2ff?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": "1200; 60",
"substance": "GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE",
"productndc": "63304-110",
"dosage_form": "TABLET, EXTENDED RELEASE",
"dea_schedule": null,
"strength_unit": "mg/1; mg/1",
"application_number": "ANDA214781",
"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.