United States· US:35916-0189_490b40e4-c895-2eee-e063-6394a90a1a0a
Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate
A medicinal product containing acetaminophen; dextromethorphan hydrobromide; doxylamine succinate, 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.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
- 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
- September 27, 2026
Packs & prices · 2
- ndc1135916018911000 CAPSULE, LIQUID FILLED in 1 BAG (35916-0189-1)
- ndc1135916-0189-1
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Acetaminophen; dextromethorphan hydrobromide; doxylamine succinate in 3 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CanadaNIGHTTIME COLD & FLU RELIEFJUNO OTC INC
- GermanyWick Medinait Mit AnisgeschmackWick Pharma Zweigniederlassung Der Procter & Gamble Gmbh
- SpainILVIGRIP NOCHE JARABELaboratorios Vicks S.L.
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Germany · Wick Medinait Mit Anisgeschmack
- Spain · Ilvigrip Noche
- Italy · Vicks Medinait
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/a90d3458-7796-4acd-9913-2a0629362156 GET /v1/drugs/a90d3458-7796-4acd-9913-2a0629362156?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; 6.25",
"substance": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"productndc": "35916-0189",
"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 acetaminophen; dextromethorphan hydrobromide; doxylamine succinate.
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.