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United States· US:58552-137_40b8865e-4141-75bb-e063-6394a90aafba

Giltuss Childrens MultiSymptom Cold and Flu

A medicinal product containing chlorpheniramine maleate; phenylephrine hydrochloride; dextromethorphan hydrobromide; acetaminophen, registered in United States by Giltuss Pharmaceutical 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…normalisedGiltuss Childrens MultiSymptom Cold a…ATC—REGISTER NO.US:58552-137_40b8865e…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN
Manufacturer
Giltuss Pharmaceutical 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
    5855213704
    1 BOTTLE in 1 CARTON (58552-137-04) / 118 mL in 1 BOTTLE
  • ndc11
    58552-137-04

Regulatory notes

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

Same medicine, other countries

Chlorpheniramine maleate; phenylephrine hydrochloride; dextromethorphan hydrobromide; acetaminophen in 1 other country

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

All chlorpheniramine maleate; phenylephrine hydrochloride; dextromethorphan hydrobromide; 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/e7c3ac7e-b749-49bf-9b5b-28013577adad
GET /v1/drugs/e7c3ac7e-b749-49bf-9b5b-28013577adad?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": "2; 5; 6.5; 325",
  "substance": "CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN",
  "productndc": "58552-137",
  "dosage_form": "SOLUTION",
  "dea_schedule": null,
  "strength_unit": "mg/5mL; mg/5mL; mg/5mL; mg/5mL",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG"
}

See everything about chlorpheniramine maleate; phenylephrine hydrochloride; dextromethorphan hydrobromide; 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.