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United States· US:55154-5791_54a012fb-214d-4dba-bf91-90ca8ee293c2

Guaifenesin and Codeine Phosphate

A medicinal product containing codeine phosphate; guaifenesin, registered in United States by Cardinal Health 107, LLC.

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedGuaifenesin and Codeine PhosphateATC—REGISTER NO.US:55154-5791_54a012f…PACKS LISTED1CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
CODEINE PHOSPHATE; GUAIFENESIN
Manufacturer
Cardinal Health 107, LLC
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 · 1

  • ndc11
    55154-5791-5

Regulatory notes

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

Same medicine, other countries

Codeine phosphate; guaifenesin in 2 other countries

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

All codeine phosphate; guaifenesin products

Authorised across Europe · EMA

The same active substance is authorised in 2 EEA countries. Names it is sold under:

  • Austria · Resyl Mit Codein
  • Finland · Recipect

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/04df5262-dc84-4005-aa17-567ce19eff17
GET /v1/drugs/04df5262-dc84-4005-aa17-567ce19eff17?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; 100",
  "substance": "CODEINE PHOSPHATE; GUAIFENESIN",
  "productndc": "55154-5791",
  "dosage_form": "SOLUTION",
  "dea_schedule": "CV",
  "strength_unit": "mg/5mL; mg/5mL",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG"
}

See everything about codeine phosphate; 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.