United States· US:64778-0446_4c4b0fd6-ca08-179a-e063-6394a90a6628
Denti-Care Denti-Rinse
A sodium fluoride product containing sodium fluoride, registered in United States by AMD Medicom. The same ATC class is registered in 13 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Sodium fluoride is registered in 13 of 19 countries.
Countries holding a registration under ATC A01AA01 (sodium fluoride), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 8 of them publish a price we can compare per daily dose
Sodium fluoride · ATC A01AA01
13 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Germany
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- SODIUM FLUORIDE
- Manufacturer
- AMD Medicom
- Country
- United States (US)
- ATC code
- A01AA01
- ATC class
- Sodium fluoride
- Defined daily dose
- 1.1 mg, O
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc1164778-0446-3
- ndc11647780446312 BOTTLE, PUMP in 1 CASE (64778-0446-3) / 1900 mL in 1 BOTTLE, PUMP (64778-0446-1)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Sodium fluoride in 12 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomColgate Duraphat 2800ppm fluoride toothpasteColgate-Palmolive (UK) Ltd
- FinlandDuraphatColgate-Palmolive A/S
- CzechiaZYMAFLUORMylan IRE Healthcare Limited, Dublin
- BelgiumFluocaril Bi-Fluore 250 Muntsmaak 250 mg/100 gU.Labs
- GermanyControcarLege Artis Pharma Gmbh + Co. Kg
- SwedenDentan 0,05 % MunsköljvätskaCooper Consumer Health B.V.
- FranceDURAPHAT 50 mg/ml, suspension dentaireCOLGATE PALMOLIVE
- Polandelmex DuraphatCP GABA GmbH
Authorised across Europe · EMA
The same active substance is authorised in 15 EEA countries. Names it is sold under:
- Austria · Zymafluor
- Belgium · Z-Fluor
- Czechia · Zymafluor
- Germany · Controcar, Fluoretten
- Finland · Duraphat
- France · Duraphat, Fluodontyl
- United Kingdom (Northern Ireland) · Duraphat, Fluoride Morningside Healthcare
- Greece · Duraphat
- Iceland · Duraphat
- Italy · Zymafluor
- Netherlands · Duraphat
- Norway · Duraphat, Flux F Med Banansmak
- Poland · Medelmex Duraphat
- Portugal · Duraphat, Maxflúor
- Sweden · Dentan, Dentan Mint
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/fbf1077a-c31b-4f25-a7c9-055bd0930928 GET /v1/drugs/fbf1077a-c31b-4f25-a7c9-055bd0930928?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": "DENTAL",
"source": "ndc",
"strength": ".02",
"substance": "SODIUM FLUORIDE",
"productndc": "64778-0446",
"dosage_form": "LIQUID",
"dea_schedule": null,
"strength_unit": "g/mL",
"application_number": null,
"marketing_category": "UNAPPROVED DRUG OTHER"
}See everything about sodium fluoride.
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.