United States· US:61825-303_47da8a7f-0d47-f1cd-e063-6394a90a84ad
Oravig
A medicinal product containing miconazole, registered in United States by Galt Pharmaceuticals, 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
- MICONAZOLE
- Manufacturer
- Galt Pharmaceuticals, 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
- ndc11618253031414 TABLET in 1 BOTTLE (61825-303-14)
- ndc1161825-303-14
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Miconazole in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomLoramyc 50mg muco-adhesive buccal tabletsLaboratoires BioAlliance Pharma
- PolandDaktarinMedezin Sp. z o.o.
- GermanyCastellaniDr. K. Hollborn & Söhne Gmbh & Co. Kg
- NetherlandsAntischimmelcrème HTP Miconazolnitraat 20 mg/g, hydrofiele crèmeHealthypharm B.V.
- FinlandDaktarinOrifarm Oy
- BelgiumAcneplus 20 mg/g - 50 mg/gLouis Widmer
- CanadaMICATIN MICONAZOLE NITRATE CREAM 2% USPWELLSPRING PHARMACEUTICAL CANADA CORP
- NorwayDaktacortMcNeil Sweden AB
Authorised across Europe · EMA
The same active substance is authorised in 23 EEA countries. Names it is sold under:
- Austria · Daktarin
- Belgium · Daktarin, Gyno-Daktarin Vaginal
- Bulgaria · Дактарин
- Cyprus · Candiplas, Daktarin
- Germany · Castellani, Daktar
- Denmark · Brentan
- Spain · Daktarin, Fungisdin
- Finland · Daktarin
- France · Daktarin, Loramyc
- United Kingdom (Northern Ireland) · Daktarin, Daktarin Aktiv
- Greece · Daktarin, Daktarin Spray
- Croatia · Rojazol, Rojazolderm
- Ireland · Daktarin
- Italy · Daktarin, Daktarin Dermatologico
- Luxembourg · Daktarin, Gyno-Daktarin
- Latvia · Miconazole Tzf
- Malta · Daktarin, Miconazol Slavia
- Netherlands · Antischimmelcrème Miconazolnitraat, Antischimmelcrème Miconazolnitraat Htp
- Norway · Daktacort, Daktar
- Poland · Daktarin, Gyno-Femidazol
- Portugal · Daktarin
- Romania · Gynozol, Miconazol Slavia
- Sweden · Daktar
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/d5b2794d-5eb8-43a8-8102-bf34df669d6a GET /v1/drugs/d5b2794d-5eb8-43a8-8102-bf34df669d6a?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": "BUCCAL",
"source": "ndc",
"strength": "50",
"substance": "MICONAZOLE",
"productndc": "61825-303",
"dosage_form": "TABLET",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "NDA022404",
"marketing_category": "NDA"
}See everything about miconazole.
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.