United States· US:76162-065_97e61aee-34b7-468d-b3ea-6d796d4365da
Daytime Cold and Flu Relief
A medicinal product containing acetaminophen; dextromethorphan hydrobromide; phenylephrine hydrochloride, registered in United States by TopCo Associates, LLC.
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; PHENYLEPHRINE HYDROCHLORIDE
- Manufacturer
- TopCo Associates, LLC
- 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
- ndc1176162065161 BLISTER PACK in 1 CARTON (76162-065-16) / 16 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
- ndc1176162-065-16
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Acetaminophen; dextromethorphan hydrobromide; phenylephrine hydrochloride 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/ac1a48a6-4f00-49b7-a745-99b775642c8e GET /v1/drugs/ac1a48a6-4f00-49b7-a745-99b775642c8e?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; 5",
"substance": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
"productndc": "76162-065",
"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; phenylephrine hydrochloride.
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.