United States· US:58578-0407_452e539e-8d6e-4150-832b-c8f6760086eb
CloSYS Silver Healthy Gums
A medicinal product containing cetylpyridinium chloride, registered in United States by Rowpar Pharmaceuticals, Inc..
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
- CETYLPYRIDINIUM CHLORIDE
- Manufacturer
- Rowpar Pharmaceuticals, Inc.
- 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 · 8
- ndc1158578-0407-1
- ndc1158578-0407-2
- ndc1158578-0407-3
- ndc1158578-0407-4
- ndc1158578040711 BOTTLE in 1 CARTON (58578-0407-1) / 946 mL in 1 BOTTLE
- ndc1158578040722 BOTTLE in 1 PACKAGE (58578-0407-2) / 946 mL in 1 BOTTLE
- ndc1158578040733 BOTTLE in 1 PACKAGE (58578-0407-3) / 946 mL in 1 BOTTLE
- ndc115857804074946 mL in 1 BOTTLE (58578-0407-4)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Cetylpyridinium chloride in 9 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CanadaANTISEPTIC ORAL RINSESAGE PRODUCTS LLC
- United KingdomAnbesol liquidAlliance Pharmaceuticals Ltd
- FranceNOVOPTINE 0,1 mg/0,4 ml, collyre en récipient unidoseSIFI (ITALIE)
- PolandHalsetBiofarm Sp. z o.o.
- GermanyAnginettenDivapharma Gmbh
- CzechiaHALSETGebro Pharma GmbH, Fieberbrunn
- NorwayPyriseptKaro Pharma AS
- Japanセチルピリジニウム塩化物水和物岩城製薬
Authorised across Europe · EMA
The same active substance is authorised in 10 EEA countries. Names it is sold under:
- Austria · Halset
- Czechia · Halset, Neoseptolete Třešeň
- Germany · Anginetten, Halstabletten - Akute Hals- Und Rachenhilfe Zur Anwendung Bei Erwachsenen Und Kindern Ab 3 Jahren
- France · Sedacollyre
- United Kingdom (Northern Ireland) · Antiseptic, First Aid Antiseptic
- Italy · Cetilsan, Cetilsan Senza Zucchero
- Malta · Cetilsan Sugar Free
- Norway · Pyrisept
- Poland · Halset, Septolete Junior
- Slovenia · Neoseptolete Z Okusom Divje Češnje, Neoseptolete Z Okusom Limone
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/f16e2859-8649-4710-8fc3-fcf0b2f1c67c GET /v1/drugs/f16e2859-8649-4710-8fc3-fcf0b2f1c67c?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": ".75",
"substance": "CETYLPYRIDINIUM CHLORIDE",
"productndc": "58578-0407",
"dosage_form": "LIQUID",
"dea_schedule": null,
"strength_unit": "g/mL",
"application_number": "M022",
"marketing_category": "OTC MONOGRAPH DRUG"
}See everything about cetylpyridinium chloride.
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.