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United States· US:0126-0022_6b3ab11f-e5c3-460b-8519-1214876dd629

PreviDent 5000 Enamel Protect

A medicinal product containing sodium fluoride and potassium nitrate, registered in United States by Colgate Oral Pharmaceuticals, Inc..

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…normalisedPreviDent 5000 Enamel ProtectATC—REGISTER NO.US:0126-0022_6b3ab11f…PACKS LISTED1CHECKEDJune 3, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
SODIUM FLUORIDE and POTASSIUM NITRATE
Manufacturer
Colgate Oral 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
June 3, 2026

Packs & prices · 1

  • ndc11
    0126002292
    100 mL in 1 BOTTLE (0126-0022-92)

Regulatory notes

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

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/e6559548-7fb1-4a08-9b7b-ad8522bf0752
GET /v1/drugs/e6559548-7fb1-4a08-9b7b-ad8522bf0752?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",
  "productid": "0126-0022_6b3ab11f-e5c3-460b-8519-1214876dd629",
  "productndc": "0126-0022",
  "dosage_form": "GEL, DENTIFRICE",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "POTASSIUM NITRATE; SODIUM FLUORIDE",
  "proprietary_name": "PreviDent 5000 Enamel Protect",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": null,
  "marketing_category": "UNAPPROVED DRUG OTHER",
  "nonproprietary_name": "SODIUM FLUORIDE and POTASSIUM NITRATE",
  "start_marketing_date": "20110330",
  "active_numerator_strength": "57.5; 5.8"
}

See everything about sodium fluoride and potassium nitrate.

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.