United States· US:36800-268_0ccb3962-d499-0a6c-e063-6294a90a0d41
TopCare Calagesic
A medicinal product containing zinc oxide; pramoxine hydrochloride, registered in United States by TOPCO ASSOCIATES 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
- ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
- Manufacturer
- TOPCO ASSOCIATES 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 · 2
- ndc1136800-268-96
- ndc113680026896177 mL in 1 CONTAINER (36800-268-96)
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/56b03ba5-509c-4795-b29d-9c8945aebc90 GET /v1/drugs/56b03ba5-509c-4795-b29d-9c8945aebc90?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": "36800-268",
"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.