United States· US:68210-5053_575a1070-780c-5032-e063-6294a90a642a
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride
A medicinal product containing phenylephrine hydrochloride; acetaminophen; dextromethorphan hydrobromide, registered in United States by Prodose, Inc..
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; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
- Manufacturer
- Prodose, Inc.
- 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 · 1
- ndc1168210-5053-1
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Phenylephrine hydrochloride; acetaminophen; dextromethorphan hydrobromide in 2 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CanadaCOUGH & COLD RELIEFJUNO OTC INC
- CzechiaPARALEN GRIP CHŘIPKA A KAŠELOpella Healthcare Czech s.r.o., Praha
Authorised across Europe · EMA
The same active substance is authorised in 2 EEA countries. Names it is sold under:
- Czechia · Paralen Grip Chřipka A Kašel
- Slovakia · Paralen Grip Chrípka A Kašeľ
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/444b61a7-e5fd-4791-9d38-a61547332a90 GET /v1/drugs/444b61a7-e5fd-4791-9d38-a61547332a90?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; 325; 10",
"substance": "PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE",
"productndc": "68210-5053",
"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 phenylephrine hydrochloride; 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.