United States· US:75834-197_53ac723b-1f67-47e5-b560-6589342a27d8
HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE
A medicinal product containing pramoxine hydrochloride; hydrocortisone acetate, registered in United States by Nivagen 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
- PRAMOXINE HYDROCHLORIDE; HYDROCORTISONE ACETATE
- Manufacturer
- Nivagen 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
- September 6, 2026
Packs & prices · 2
- ndc1175834-197-01
- ndc1175834197011 TUBE, WITH APPLICATOR in 1 CARTON (75834-197-01) / 28.5 g in 1 TUBE, WITH APPLICATOR
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Pramoxine hydrochloride; hydrocortisone acetate 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/4c5c088f-3100-4c05-8644-d00da5776f6c GET /v1/drugs/4c5c088f-3100-4c05-8644-d00da5776f6c?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; 25",
"substance": "PRAMOXINE HYDROCHLORIDE; HYDROCORTISONE ACETATE",
"productndc": "75834-197",
"dosage_form": "CREAM",
"dea_schedule": null,
"strength_unit": "mg/g; mg/g",
"application_number": null,
"marketing_category": "UNAPPROVED DRUG OTHER"
}See everything about pramoxine hydrochloride; hydrocortisone acetate.
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.