United States· US:50991-540_3e5ed178-d5d8-b8d4-e063-6394a90a91db
Duratuss AC
A medicinal product containing codeine phosphate; dexbrompheniramine maleate, 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
- CODEINE PHOSPHATE; DEXBROMPHENIRAMINE MALEATE
- 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
- ndc115099154016473 mL in 1 BOTTLE (50991-540-16)
- ndc11509915402020 mL in 1 BOTTLE (50991-540-20)
- ndc1150991-540-16
- ndc1150991-540-20
Regulatory notes
No shortage, Orange Book or US label notes for this record.
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/d172be1c-46a8-4637-b636-6e14017a0f93 GET /v1/drugs/d172be1c-46a8-4637-b636-6e14017a0f93?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": "10; 1",
"substance": "CODEINE PHOSPHATE; DEXBROMPHENIRAMINE MALEATE",
"productndc": "50991-540",
"dosage_form": "LIQUID",
"dea_schedule": "CV",
"strength_unit": "mg/5mL; mg/5mL",
"application_number": "M012",
"marketing_category": "OTC MONOGRAPH DRUG"
}See everything about codeine phosphate; dexbrompheniramine maleate.
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.