United States· US:0485-0204_4746cbef-775f-90ce-e063-6394a90a0781

Rynex

A medicinal product containing phenylephrine hydrochloride; brompheniramine maleate; dextromethorphan hydrobromide, registered in United States by Edwards Pharmaceuticals, Inc.

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…normalisedRynexATC—REGISTER NO.US:0485-0204_4746cbef…PACKS LISTED4CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Manufacturer
Edwards 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

  • ndc11
    0485020416
    473 mL in 1 BOTTLE (0485-0204-16)
  • ndc11
    0485020404
    118 mL in 1 BOTTLE, PLASTIC (0485-0204-04)
  • ndc11
    0485-0204-04
  • ndc11
    0485-0204-16

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Phenylephrine hydrochloride; brompheniramine maleate; dextromethorphan hydrobromide in 1 other country

What each register calls a product with the same active substance — salts and hydrates count as the same.

All phenylephrine hydrochloride; brompheniramine maleate; dextromethorphan hydrobromide products

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/c59681b9-438e-49f5-b75e-9ee0483bc865
GET /v1/drugs/c59681b9-438e-49f5-b75e-9ee0483bc865?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": "2.5; 1; 5",
  "substance": "PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE",
  "productndc": "0485-0204",
  "dosage_form": "LIQUID",
  "dea_schedule": null,
  "strength_unit": "mg/5mL; mg/5mL; mg/5mL",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG"
}

See everything about phenylephrine hydrochloride; brompheniramine maleate; 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.