United States· US:50991-535_2683803e-5e2f-b2bc-e063-6394a90a4feb
Duraflu
A medicinal product containing pseudoephedrine hydrochloride; acetaminophen; dextromethorphan hydrobromide; guaifenesin, registered in United States by Poly Pharmaceuticals, 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
- PSEUDOEPHEDRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Manufacturer
- Poly Pharmaceuticals, 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 · 4
- ndc115099153501100 TABLET in 1 BOTTLE (50991-535-01)
- ndc1150991535026 BLISTER PACK in 1 CARTON (50991-535-02) / 2 TABLET in 1 BLISTER PACK
- ndc1150991-535-01
- ndc1150991-535-02
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Pseudoephedrine hydrochloride; acetaminophen; 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.
- CanadaBENYLIN ALL-IN-ONE COLD, FLU & COUGH LIQUID GELSMCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC
- PolandGrypolekKato Labs Sp. z o.o.
Authorised across Europe · EMA
The same active substance is authorised in 1 EEA country. Names it is sold under:
- Poland · Grypolek
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/ade0dc28-757b-4bd7-984a-f8a260827a33 GET /v1/drugs/ade0dc28-757b-4bd7-984a-f8a260827a33?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": "60; 325; 20; 200",
"substance": "PSEUDOEPHEDRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"productndc": "50991-535",
"dosage_form": "TABLET",
"dea_schedule": null,
"strength_unit": "mg/1; mg/1; mg/1; mg/1",
"application_number": "M012",
"marketing_category": "OTC MONOGRAPH DRUG"
}See everything about pseudoephedrine hydrochloride; acetaminophen; 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.