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United States· US:80513-301_220d0f73-1573-686b-e063-6394a90a9a50

DAYTIME COLD AND FLU RELIEF SOFTGELS

A medicinal product containing dextromethorphan hydrobromide; diphenhydramine hydrochloride; acetaminophen, registered in United States by Advanced Rx LLC.

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 COLD AND FLU RELIEF SOFTGELSATC—REGISTER NO.US:80513-301_220d0f73…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
DEXTROMETHORPHAN HYDROBROMIDE; DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN
Manufacturer
Advanced Rx 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

  • ndc11
    8051330150
    50 CAPSULE, GELATIN COATED in 1 BOTTLE (80513-301-50)
  • ndc11
    80513-301-50

Regulatory notes

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

Same medicine, other countries

Dextromethorphan hydrobromide; diphenhydramine hydrochloride; 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; diphenhydramine hydrochloride; 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/5e8129b6-2a1c-4150-a040-ce27a99e32fc
GET /v1/drugs/5e8129b6-2a1c-4150-a040-ce27a99e32fc?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",
  "substance": "DEXTROMETHORPHAN HYDROBROMIDE; DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN",
  "productndc": "80513-301",
  "dosage_form": "CAPSULE, GELATIN COATED",
  "dea_schedule": null,
  "strength_unit": "mg/1; mg/1; mg/1",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG"
}

See everything about dextromethorphan hydrobromide; diphenhydramine hydrochloride; 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.