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United States· US:81033-103_2cee75e1-ee97-6129-e063-6394a90a03dd

Dextromethorphan HBr and Guaifenesin Oral Solution

A medicinal product containing guaifenesin; dextromethorphan hydrobromide, registered in United States by KESIN PHARMA CORPORATION.

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…normalisedDextromethorphan HBr and Guaifenesin …ATC—REGISTER NO.US:81033-103_2cee75e1…PACKS LISTED4CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Manufacturer
KESIN PHARMA CORPORATION
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
    8103310350
    100 CUP, UNIT-DOSE in 1 CASE (81033-103-50) / 5 mL in 1 CUP, UNIT-DOSE (81033-103-05)
  • ndc11
    8103310351
    100 CUP, UNIT-DOSE in 1 CASE (81033-103-51) / 10 mL in 1 CUP, UNIT-DOSE (81033-103-10)
  • ndc11
    81033-103-50
  • ndc11
    81033-103-51

Regulatory notes

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

Same medicine, other countries

Guaifenesin; dextromethorphan hydrobromide in 2 other countries

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

All guaifenesin; dextromethorphan hydrobromide products

Authorised across Europe · EMA

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

  • Spain · Broncomedical Con Guaifenesina, Cinfatós Expectorante
  • Italy · Bronchenolo Sedativo E Fluidificante, Bronchenolo Sedativo E Fluidificante Gusto Menta

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/80f1eeff-9f73-4cb7-98cf-81d7ab3e2426
GET /v1/drugs/80f1eeff-9f73-4cb7-98cf-81d7ab3e2426?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": "100; 10",
  "substance": "GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE",
  "productndc": "81033-103",
  "dosage_form": "LIQUID",
  "dea_schedule": null,
  "strength_unit": "mg/5mL; mg/5mL",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG"
}

See everything about guaifenesin; 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.