United States· US:63783-400_2a1d770f-d9a7-4980-a1f2-cf4df96d0f40
ORTHO GUARD
A sodium fluoride product containing sodium fluoride, registered in United States by Massco Dental A Division of Dunagin Pharmaceuticals. The same ATC class is registered in 4 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 4 of 19 countries.
Countries holding a registration under ATC A12CD01 (sodium fluoride), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 2 of them publish a price we can compare per daily dose
Sodium fluoride · ATC A12CD01
4 / 19 countries
- Belgiumprice
- Germany
- United Kingdom
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- SODIUM FLUORIDE
- Manufacturer
- Massco Dental A Division of Dunagin Pharmaceuticals
- Country
- United States (US)
- ATC code
- A12CD01
- ATC class
- Sodium fluoride
- Defined daily dose
- 88 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
- ndc1163783-400-16
- ndc116378340016473 mL in 1 BOTTLE (63783-400-16)
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
- CzechiaZYMAFLUORCooper Consumer Health B.V., Diemen
- 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/ab917aaa-89b8-4787-9a32-3412cefee0a4 GET /v1/drugs/ab917aaa-89b8-4787-9a32-3412cefee0a4?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": "4.4",
"substance": "SODIUM FLUORIDE",
"productndc": "63783-400",
"dosage_form": "GEL, DENTIFRICE",
"dea_schedule": null,
"strength_unit": "mg/10mL",
"application_number": "M021",
"marketing_category": "OTC MONOGRAPH DRUG"
}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.