United States· US:0135-0484_0fb8d5cd-17d5-f0ac-e063-6394a90ab28d
SENSODYNE PRONAMEL
A medicinal product containing potassium nitrate; sodium fluoride, registered in United States by Haleon US Holdings LLC.
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
- POTASSIUM NITRATE; SODIUM FLUORIDE
- Manufacturer
- Haleon US Holdings LLC
- 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 · 12
- ndc1101350484011 TUBE in 1 CARTON (0135-0484-01) / 113 g in 1 TUBE
- ndc1101350484021 TUBE in 1 CARTON (0135-0484-02) / 76.5 g in 1 TUBE
- ndc11013504840322.6 g in 1 TUBE (0135-0484-03)
- ndc1101350484041 TUBE in 1 CARTON (0135-0484-04) / 184.3 g in 1 TUBE
- ndc1101350484052 TUBE in 1 CARTON (0135-0484-05) / 113 g in 1 TUBE
- ndc1101350484064 TUBE in 1 CARTON (0135-0484-06) / 184.3 g in 1 TUBE
- ndc110135-0484-01
- ndc110135-0484-02
- ndc110135-0484-03
- ndc110135-0484-04
- ndc110135-0484-05
- ndc110135-0484-06
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/ae8ea265-2150-4747-af54-06c454dda869 GET /v1/drugs/ae8ea265-2150-4747-af54-06c454dda869?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": "50; 1.15",
"substance": "POTASSIUM NITRATE; SODIUM FLUORIDE",
"productndc": "0135-0484",
"dosage_form": "PASTE",
"dea_schedule": null,
"strength_unit": "mg/g; mg/g",
"application_number": "M022",
"marketing_category": "OTC MONOGRAPH DRUG"
}See everything about potassium nitrate; 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.