United States· US:57344-163_284f7751-0db0-c1c2-e063-6294a90aecee
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
A medicinal product containing guaifenesin; phenylephrine hydrochloride; acetaminophen; dextromethorphan hydrobromide, registered in United States by AAA Pharmaceutical, 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
- GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
- Manufacturer
- AAA Pharmaceutical, 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 · 2
- ndc1157344163052 BLISTER PACK in 1 CARTON (57344-163-05) / 12 TABLET, COATED in 1 BLISTER PACK
- ndc1157344-163-05
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Guaifenesin; phenylephrine hydrochloride; acetaminophen; dextromethorphan hydrobromide in 1 other country
What each register calls a product with the same active substance — salts and hydrates count as the same.
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/5c7644ee-7a65-4b42-b160-412ea6d46933 GET /v1/drugs/5c7644ee-7a65-4b42-b160-412ea6d46933?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": "200; 5; 325; 10",
"substance": "GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE",
"productndc": "57344-163",
"dosage_form": "TABLET, COATED",
"dea_schedule": null,
"strength_unit": "mg/1; mg/1; mg/1; mg/1",
"application_number": "M012",
"marketing_category": "OTC MONOGRAPH DRUG"
}See everything about guaifenesin; 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.