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United States· US:51316-525_4dc12a72-b840-f61f-e063-6394a90a0da0

DAYTIME SEVERE COLD AND FLU

A medicinal product containing dextromethorphan hydrobromide; phenylephrine hydrochloride; guaifenesin; acetaminophen, registered in United States by CVS HEALTH CORP.

US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedDAYTIME SEVERE COLD AND FLUATC—REGISTER NO.US:51316-525_4dc12a72…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN; ACETAMINOPHEN
Manufacturer
CVS HEALTH CORP
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

  • ndc11
    51316-525-24
  • ndc11
    5131652524
    2 BLISTER PACK in 1 CARTON (51316-525-24) / 12 CAPSULE in 1 BLISTER PACK

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Dextromethorphan hydrobromide; phenylephrine hydrochloride; guaifenesin; acetaminophen in 1 other country

What each register calls a product with the same active substance — salts and hydrates count as the same.

All dextromethorphan hydrobromide; phenylephrine hydrochloride; guaifenesin; acetaminophen products

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/ecb87366-85c0-404d-9b61-6e4a2862e196
GET /v1/drugs/ecb87366-85c0-404d-9b61-6e4a2862e196?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": "10; 5; 200; 325",
  "substance": "DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN; ACETAMINOPHEN",
  "productndc": "51316-525",
  "dosage_form": "CAPSULE",
  "dea_schedule": null,
  "strength_unit": "mg/1; mg/1; mg/1; mg/1",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG"
}

See everything about dextromethorphan hydrobromide; phenylephrine hydrochloride; guaifenesin; acetaminophen.

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.