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United States· US:0574-1104_aa6625e1-c78d-417a-bdf3-fc09a5b26966

Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide

A medicinal product containing brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride, registered in United States by Padagis US 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…normalisedBrompheniramine Maleate, Pseudoephedr…ATC—REGISTER NO.US:0574-1104_aa6625e1…PACKS LISTED4CHECKEDJuly 19, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Manufacturer
Padagis US LLC
Country
United States (US)
ATC code
—
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
July 19, 2026

Packs & prices · 4

  • ndc11
    0574-1104-04
  • ndc11
    0574-1104-16
  • ndc11
    0574110404
    118 mL in 1 BOTTLE, PLASTIC (0574-1104-04)
  • ndc11
    0574110416
    473 mL in 1 BOTTLE, PLASTIC (0574-1104-16)

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/e4b7e4b2-e024-41d0-a452-5ee258096617
GET /v1/drugs/e4b7e4b2-e024-41d0-a452-5ee258096617?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": "2; 10; 30",
  "substance": "BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
  "productndc": "0574-1104",
  "dosage_form": "SYRUP",
  "dea_schedule": null,
  "strength_unit": "mg/5mL; mg/5mL; mg/5mL",
  "application_number": "ANDA205292",
  "marketing_category": "ANDA"
}

See everything about brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride.

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.