United States· US:0135-0578_1599c55d-8de5-cc14-e063-6394a90aba82
FLONASE
A medicinal product containing acetaminophen; chlorpheniramine maleate; phenylephrine hydrochloride, registered in United States by Haleon US Holdings LLC.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
- Manufacturer
- Haleon US Holdings 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 · 6
- ndc1101350578011 BLISTER PACK in 1 CARTON (0135-0578-01) / 12 TABLET in 1 BLISTER PACK
- ndc1101350578024 BLISTER PACK in 1 CARTON (0135-0578-02) / 48 TABLET in 1 BLISTER PACK
- ndc1101350578038 BLISTER PACK in 1 CARTON (0135-0578-03) / 96 TABLET in 1 BLISTER PACK
- ndc110135-0578-01
- ndc110135-0578-02
- ndc110135-0578-03
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Acetaminophen; chlorpheniramine maleate; phenylephrine hydrochloride in 3 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CanadaCOLTALIN COLD & ALLERGY TABLETSFORTUNE PHARMACAL CO. LTD.
- SpainABACAT GRANULADO PARA SOLUCIÓN ORAL.Tarbis Farma S.L.
- PolandFlucontrol HotAflofarm Farmacja Polska Sp. z o.o.
Authorised across Europe · EMA
The same active substance is authorised in 5 EEA countries. Names it is sold under:
- Bulgaria · Тайлолфен Хот
- Spain · Abacat, Anticatarral Edigen
- Malta · Flucontrol Max
- Poland · Flucontrol Hot, Flucontrol Max
- Portugal · Gripalgin
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/012045e8-0111-4455-9631-6d6b7c377588 GET /v1/drugs/012045e8-0111-4455-9631-6d6b7c377588?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": "325; 2; 5",
"substance": "ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE",
"productndc": "0135-0578",
"dosage_form": "TABLET",
"dea_schedule": null,
"strength_unit": "mg/1; mg/1; mg/1",
"application_number": "M012",
"marketing_category": "OTC MONOGRAPH DRUG"
}See everything about acetaminophen; chlorpheniramine maleate; phenylephrine hydrochloride.
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.