United States· US:70000-0400_0d1994b2-3c1b-6322-e063-6394a90a1b6c
Leader Calamine Plus
A medicinal product containing zinc oxide; pramoxine hydrochloride, registered in United States by Cardinal Health, 110 dba Leader.
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
- ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
- Manufacturer
- Cardinal Health, 110 dba Leader
- 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 · 2
- ndc117000004001177 mL in 1 CONTAINER (70000-0400-1)
- ndc1170000-0400-1
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Zinc oxide; pramoxine hydrochloride in 1 other country
What each register calls a product with the same active substance — salts and hydrates count as the same.
Authorised across Europe · EMA
The same active substance is authorised in 1 EEA country. Names it is sold under:
- Netherlands · Nestosyl
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/f1141c1f-a382-4488-9d7e-6b9dee5ca424 GET /v1/drugs/f1141c1f-a382-4488-9d7e-6b9dee5ca424?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": "80; 10",
"substance": "ZINC OXIDE; PRAMOXINE HYDROCHLORIDE",
"productndc": "70000-0400",
"dosage_form": "LOTION",
"dea_schedule": null,
"strength_unit": "mg/mL; mg/mL",
"application_number": "M016",
"marketing_category": "OTC MONOGRAPH DRUG"
}See everything about zinc oxide; 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.