United States· US:35916-0166_47b5293b-c76d-4cd3-e063-6394a90a29b5
Acetaminophen, Guaifenesin, Phenylephrine Hcl and Dextromethorphan HBr
A medicinal product containing phenylephrine hydrochloride; dextromethorphan hydrobromide; acetaminophen; guaifenesin, 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
- PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; GUAIFENESIN
- 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 · 2
- ndc1135916016612 BLISTER PACK in 1 CARTON (35916-0166-1) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
- ndc1135916-0166-1
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/848c7b43-b0ab-4f56-93e1-096630484a68 GET /v1/drugs/848c7b43-b0ab-4f56-93e1-096630484a68?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": "5; 10; 325; 200",
"substance": "PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; GUAIFENESIN",
"productndc": "35916-0166",
"dosage_form": "CAPSULE, LIQUID FILLED",
"dea_schedule": null,
"strength_unit": "mg/1; mg/1; mg/1; mg/1",
"application_number": "M012",
"marketing_category": "OTC MONOGRAPH DRUG"
}See everything about phenylephrine hydrochloride; dextromethorphan hydrobromide; acetaminophen; 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.