United States· US:55154-5783_ec2683d2-46f6-4f2b-9655-484e652e4a59

GUAIFENESIN DM

A opium alkaloids and derivatives product containing guaifenesin and dextromethorphan, registered in United States by Cardinal Health 107, LLC. The same ATC class is registered in 2 of our 19 countries.

ATC R05DAUS 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…normalisedGUAIFENESIN DMATCR05DAREGISTER NO.US:55154-5783_ec2683d…PACKS LISTED1CHECKEDJune 3, 2026

Where it is registered

Guaifenesin and dextromethorphan is registered in 2 of 19 countries.

Countries holding a registration under ATC R05DA (opium alkaloids and derivatives), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 2 of them publish a price we can compare per daily dose

Guaifenesin and dextromethorphan · ATC R05DA

2 / 19 countries

  • Belgiumprice
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
GUAIFENESIN and DEXTROMETHORPHAN
Manufacturer
Cardinal Health 107, LLC
Country
United States (US)
ATC code
R05DA
ATC class
Opium alkaloids and derivatives
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
June 3, 2026

Packs & prices · 1

  • ndc11
    5515457835
    5 CUP, UNIT-DOSE in 1 BAG (55154-5783-5) / 10 mL in 1 CUP, UNIT-DOSE

Regulatory notes

UNII (FDA substance ID)
7355X3ROTS
DEXTROMETHORPHAN
RxCUI 236146
DailyMed SPL labels
1 version tracked

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/ed20001d-c2f6-47ab-ad22-27f288ce37f9
GET /v1/drugs/ed20001d-c2f6-47ab-ad22-27f288ce37f9?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.

{
  "unii": {
    "unii": "7355X3ROTS",
    "rxcui": "236146",
    "inchikey": "MKXZASYAUGDDCJ-NJAFHUGGSA-N",
    "display_name": "DEXTROMETHORPHAN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "9cfb1abb-98c4-4e90-8dd7-fcffc112f988": {
      "match": "brand_token",
      "title": "GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [CARDINAL HEALTH 107, LLC]",
      "spl_version": "8",
      "published_date": "2026-05-21"
    }
  },
  "productid": "55154-5783_ec2683d2-46f6-4f2b-9655-484e652e4a59",
  "productndc": "55154-5783",
  "dosage_form": "SYRUP",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DEXTROMETHORPHAN; GUAIFENESIN",
  "proprietary_name": "GUAIFENESIN DM",
  "active_ingred_unit": "mg/5mL; mg/5mL",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "GUAIFENESIN and DEXTROMETHORPHAN",
  "start_marketing_date": "19920701",
  "active_numerator_strength": "10; 100"
}

See everything about guaifenesin and dextromethorphan.

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.