United States· US:69729-322_d9f8d76e-5f7a-fb3c-e053-2995a90a3125
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl
A medicinal product containing acetaminophen; chlorpheniramine maleate; phenylephrine hydrochloride, registered in United States by OPMX 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; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
- Manufacturer
- OPMX 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 · 6
- ndc1169729322272 TABLET in 1 POUCH (69729-322-27)
- ndc11697293223712 TABLET in 1 POUCH (69729-322-37)
- ndc116972932238144 TABLET in 1 POUCH (69729-322-38)
- ndc1169729-322-27
- ndc1169729-322-37
- ndc1169729-322-38
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Acetaminophen; chlorpheniramine maleate; phenylephrine hydrochloride in 3 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SpainABACAT GRANULADO PARA SOLUCIÓN ORAL.Tarbis Farma S.L.
- PolandFlucontrol HotAflofarm Farmacja Polska Sp. z o.o.
- CanadaBENYLIN EXTRA STRENGTH COLD & SINUS NIGHTMCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC
Authorised across Europe · EMA
The same active substance is authorised in 5 EEA countries. Names it is sold under:
- Bulgaria · Тайлолфен Хот
- Spain · Abacat, Anticatarral Edigen
- Malta · Flucontrol Max
- Poland · Flucontrol Hot, Flucontrol Max
- Portugal · Gripalgin
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/4a3467e6-a20d-4b7e-b145-4b47b3345a8c GET /v1/drugs/4a3467e6-a20d-4b7e-b145-4b47b3345a8c?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": "500; 4; 10",
"substance": "ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE",
"productndc": "69729-322",
"dosage_form": "TABLET",
"dea_schedule": null,
"strength_unit": "mg/1; mg/1; mg/1",
"application_number": "M012",
"marketing_category": "OTC MONOGRAPH DRUG"
}See everything about acetaminophen; chlorpheniramine maleate; 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.