United States· US:52083-400_7e831d13-64c5-4ee2-a290-d1d93ceec80f

ZYNCOF

A medicinal product containing dextromethorphan hydrobromide; guaifenesin, registered in United States by Kramer Novis.

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…normalisedZYNCOFATC—REGISTER NO.US:52083-400_7e831d13…PACKS LISTED6CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Manufacturer
Kramer Novis
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 · 6

  • ndc11
    5208340001
    30 mL in 1 BOTTLE, PLASTIC (52083-400-01)
  • ndc11
    5208340004
    120 mL in 1 BOTTLE, PLASTIC (52083-400-04)
  • ndc11
    5208340016
    474 mL in 1 BOTTLE, PLASTIC (52083-400-16)
  • ndc11
    52083-400-16
  • ndc11
    52083-400-01
  • ndc11
    52083-400-04

Regulatory notes

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

Same medicine, other countries

Dextromethorphan hydrobromide; guaifenesin in 2 other countries

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

All dextromethorphan hydrobromide; guaifenesin 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/f2be47c7-a89c-4404-8fa0-e5449aa70fc9
GET /v1/drugs/f2be47c7-a89c-4404-8fa0-e5449aa70fc9?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": "20; 400",
  "substance": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
  "productndc": "52083-400",
  "dosage_form": "SYRUP",
  "dea_schedule": null,
  "strength_unit": "mg/5mL; mg/5mL",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG"
}

See everything about dextromethorphan hydrobromide; 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.