United States· US:35916-0184_50039825-a8a4-cd65-e063-6294a90a5fd6
Acetaminophen, Dextromethorphan HBr ,Guaifenesin
A medicinal product containing guaifenesin; acetaminophen; dextromethorphan hydrobromide, registered in United States by Softgel Healthcare Pvt Ltd.
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
- GUAIFENESIN; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
- Manufacturer
- Softgel Healthcare Pvt Ltd
- 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
- ndc1135916018423000 CAPSULE, LIQUID FILLED in 1 POUCH (35916-0184-2)
- ndc1135916018432 POUCH in 1 BOX (35916-0184-3) / 2000 CAPSULE, LIQUID FILLED in 1 POUCH
- ndc1135916018442 BAG in 1 BOX (35916-0184-4) / 1500 CAPSULE, LIQUID FILLED in 1 BAG
- ndc1135916-0184-2
- ndc1135916-0184-3
- ndc1135916-0184-4
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Guaifenesin; acetaminophen; dextromethorphan hydrobromide in 1 other country
What each register calls a product with the same active substance — salts and hydrates count as the same.
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/09d735c8-1881-4ffc-af0c-8216ac62e13f GET /v1/drugs/09d735c8-1881-4ffc-af0c-8216ac62e13f?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": "200; 325; 10",
"substance": "GUAIFENESIN; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE",
"productndc": "35916-0184",
"dosage_form": "CAPSULE, LIQUID FILLED",
"dea_schedule": null,
"strength_unit": "mg/1; mg/1; mg/1",
"application_number": "M012",
"marketing_category": "OTC MONOGRAPH DRUG"
}See everything about guaifenesin; acetaminophen; 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.