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United States· US:55319-628_2e2c825a-b5bd-9b82-e063-6394a90aa88f

MAXIMUM STRENGTH COLD AND FLU

A medicinal product containing dextromethorphan hydrobromide; phenylephrine hydrochloride; acetaminophen; guaifenesin, registered in United States by FAMILY DOLLAR SERVICES.

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…normalisedMAXIMUM STRENGTH COLD AND FLUATC—REGISTER NO.US:55319-628_2e2c825a…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; GUAIFENESIN
Manufacturer
FAMILY DOLLAR SERVICES
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
    55319-628-16
  • ndc11
    5531962816
    16 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (55319-628-16)

Regulatory notes

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

Same medicine, other countries

Dextromethorphan hydrobromide; phenylephrine hydrochloride; acetaminophen; guaifenesin 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; acetaminophen; guaifenesin 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/7ab766d1-4e1c-4178-9d75-193a96e68556
GET /v1/drugs/7ab766d1-4e1c-4178-9d75-193a96e68556?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; 325; 200",
  "substance": "DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; GUAIFENESIN",
  "productndc": "55319-628",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "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; acetaminophen; guaifenesin.

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.