United States· US:58657-500_4e6980b2-573c-2636-e063-6294a90ac0f4
Codeine-Guaifenesin
A medicinal product containing codeine phosphate; guaifenesin, registered in United States by Method Pharmaceuticals, LLC.
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; GUAIFENESIN
- Manufacturer
- Method Pharmaceuticals, 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 · 4
- ndc1158657-500-16
- ndc115865750004120 mL in 1 BOTTLE (58657-500-04)
- ndc115865750016473 mL in 1 BOTTLE (58657-500-16)
- ndc1158657-500-04
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.
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/bb1b1d76-ecbf-451b-b375-297fa8cce524 GET /v1/drugs/bb1b1d76-ecbf-451b-b375-297fa8cce524?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": "58657-500",
"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.