United States· US:0378-8222_1b5de1cf-d19f-424b-86c0-e2ebcb0b3cf0
VUSION
A medicinal product containing miconazole nitrate; zinc oxide; petrolatum, registered in United States by Mylan 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
- MICONAZOLE NITRATE; ZINC OXIDE; PETROLATUM
- Manufacturer
- Mylan 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 27, 2026
Packs & prices · 2
- ndc1103788222501 TUBE in 1 CARTON (0378-8222-50) / 50 g in 1 TUBE
- ndc110378-8222-50
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/0392568f-8f64-4819-84c5-e548fa075bab GET /v1/drugs/0392568f-8f64-4819-84c5-e548fa075bab?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": "2.5; 150; 813.5",
"substance": "MICONAZOLE NITRATE; ZINC OXIDE; PETROLATUM",
"productndc": "0378-8222",
"dosage_form": "OINTMENT",
"dea_schedule": null,
"strength_unit": "mg/g; mg/g; mg/g",
"application_number": "NDA021026",
"marketing_category": "NDA AUTHORIZED GENERIC"
}See everything about miconazole nitrate; zinc oxide; petrolatum.
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.