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United States· US:35916-2211_5302bc8b-119a-3337-e063-6294a90a57c8

Acetominophen, Dextromethorphan hydrobromide

A medicinal product containing dextromethorphan hydrobromide; acetaminophen, registered in United States by Softgel Healthcare Private Limited.

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

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedAcetominophen, Dextromethorphan hydro…ATC—REGISTER NO.US:35916-2211_5302bc8…PACKS LISTED1CHECKEDAugust 2, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN
Manufacturer
Softgel Healthcare Private Limited
Country
United States (US)
ATC code
—
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
August 2, 2026

Packs & prices · 1

  • ndc11
    35916-2211-1

Regulatory notes

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

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/dd044ef1-9879-49cc-85f7-756c3304f670
GET /v1/drugs/dd044ef1-9879-49cc-85f7-756c3304f670?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": "325; 10",
  "substance": "DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN",
  "productndc": "35916-2211",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "dea_schedule": null,
  "strength_unit": "mg/1; mg/1",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG"
}

See everything about dextromethorphan hydrobromide; acetaminophen.

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.