United States· US:65954-068_9ff20919-1f1d-41b7-8786-1c06d1dd675f
Colgate
A sodium monofluorophosphate product containing sodium monofluorophosphate, registered in United States by Mission Hills S.A de C.V.
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
- SODIUM MONOFLUOROPHOSPHATE
- Manufacturer
- Mission Hills S.A de C.V
- Country
- United States (US)
- ATC code
- A12CD02
- ATC class
- Sodium monofluorophosphate
- Defined daily dose
- 0.152 g, O
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- June 3, 2026
Packs & prices · 4
- ndc1165954068481 TUBE in 1 CARTON (65954-068-48) / 226 g in 1 TUBE
- ndc1165954068581 TUBE in 1 CARTON (65954-068-58) / 70 g in 1 TUBE
- ndc1165954068601 TUBE in 1 CARTON (65954-068-60) / 170 g in 1 TUBE
- ndc1165954068691 TUBE in 1 CARTON (65954-068-69) / 113 g in 1 TUBE
Regulatory notes
Same medicine, other countries
Sodium monofluorophosphate in 1 other country
What each register calls a product with the same active substance — salts and hydrates count as the same.
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/05a28ceb-7ed4-4ce4-b7c0-7983b3c9070d GET /v1/drugs/05a28ceb-7ed4-4ce4-b7c0-7983b3c9070d?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.
{
"unii": {
"unii": "C810JCZ56Q",
"rxcui": "56501",
"inchikey": "BFDWBSRJQZPEEB-UHFFFAOYSA-L",
"display_name": "SODIUM MONOFLUOROPHOSPHATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "DENTAL",
"spl_meta": {
"f0e68196-8566-443b-9cc8-b57d5c001558": {
"match": "brand_token",
"title": "COLGATE KIDS CAVITY PROTECTION (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]",
"spl_version": "1",
"published_date": "2026-05-28"
}
},
"productid": "65954-068_9ff20919-1f1d-41b7-8786-1c06d1dd675f",
"productndc": "65954-068",
"dosage_form": "GEL, DENTIFRICE",
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "SODIUM MONOFLUOROPHOSPHATE",
"shortage_reason": "Sodium Chloride 0.9% Injection",
"shortage_status": "current",
"proprietary_name": "Colgate",
"active_ingred_unit": "mg/g",
"application_number": "M021",
"marketing_category": "OTC MONOGRAPH DRUG",
"nonproprietary_name": "SODIUM MONOFLUOROPHOSPHATE",
"start_marketing_date": "20130301",
"active_numerator_strength": "1"
}See everything about sodium monofluorophosphate.
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.