United States· US:54766-716_431495fb-6225-9c16-e063-6394a90a14ba
Pramosone Cream
A medicinal product containing hydrocortisone acetate; pramoxine hydrochloride, registered in United States by Sebela Pharmaceuticals Inc..
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
- HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
- Manufacturer
- Sebela 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
- July 26, 2026
Packs & prices · 4
- ndc11547667160357 g in 1 TUBE (54766-716-03)
- ndc11547667160428.4 g in 1 TUBE (54766-716-04)
- ndc1154766-716-03
- ndc1154766-716-04
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Hydrocortisone acetate; pramoxine hydrochloride in 2 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CanadaPRAMOX HC CREAMDERMTEK PHARMA INC
- United KingdomProctofoam HC foam enemaMeda Pharmaceuticals Ltd
Authorised across Europe · EMA
The same active substance is authorised in 1 EEA country. Names it is sold under:
- United Kingdom (Northern Ireland) · Proctofoam Hc
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/3696673b-bf7b-4401-86fa-cdb1c84c9044 GET /v1/drugs/3696673b-bf7b-4401-86fa-cdb1c84c9044?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": "TOPICAL",
"source": "ndc",
"strength": "10; 10",
"substance": "HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE",
"productndc": "54766-716",
"dosage_form": "CREAM",
"dea_schedule": null,
"strength_unit": "mg/g; mg/g",
"application_number": "ANDA085368",
"marketing_category": "ANDA"
}See everything about hydrocortisone acetate; pramoxine hydrochloride.
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.