Back to search

United States· US:50580-245_598dbb96-4645-0c9b-e063-6394a90ac1da

Childrens TYLENOL

A medicinal product containing acetaminophen; chlorpheniramine maleate; dextromethorphan hydrobromide, registered in United States by Kenvue Brands LLC.

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

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedChildrens TYLENOLATC—REGISTER NO.US:50580-245_598dbb96…PACKS LISTED3CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Manufacturer
Kenvue Brands 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 · 3

  • ndc11
    50580-245-01
  • ndc11
    50580-245-02
  • ndc11
    50580-245-12

Regulatory notes

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

Same medicine, other countries

Acetaminophen; chlorpheniramine maleate; dextromethorphan hydrobromide in 1 other country

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

All acetaminophen; chlorpheniramine maleate; dextromethorphan hydrobromide products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Spain · Coughgrip, Farsicold
  • Italy · Sobrepin Tosse Influenza Raffreddore
  • Malta · Normogrip Antitussive

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/306dc14a-2e21-4d6c-8017-938231d37a84
GET /v1/drugs/306dc14a-2e21-4d6c-8017-938231d37a84?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": "160; 1; 5",
  "substance": "ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE",
  "productndc": "50580-245",
  "dosage_form": "SUSPENSION",
  "dea_schedule": null,
  "strength_unit": "mg/5mL; mg/5mL; mg/5mL",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG"
}

See everything about acetaminophen; chlorpheniramine maleate; 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.