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United States· US:80425-0364_2a994ea2-2577-6513-e063-6394a90a7bc2

diclofenac epolamine

A medicinal product containing diclofenac epolamine, registered in United States by Advanced Rx of Tennessee, LLC.

US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normaliseddiclofenac epolamineATC—REGISTER NO.US:80425-0364_2a994ea…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
DICLOFENAC EPOLAMINE
Manufacturer
Advanced Rx of Tennessee, 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

  • ndc11
    80425-0364-1
  • ndc11
    8042503641
    6 POUCH in 1 CARTON (80425-0364-1) / 5 SYSTEM in 1 POUCH

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Diclofenac epolamine in 4 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All diclofenac epolamine products

Authorised across Europe · EMA

The same active substance is authorised in 18 EEA countries. Names it is sold under:

  • Austria · Flector Ep
  • Belgium · Diclofenac Patch Ab, Flalgo
  • Cyprus · Flector Tissugel
  • Czechia · Flalgo, Flector
  • Germany · Flector
  • Denmark · Flector
  • Spain · Flectormed
  • France · Diclofenac Urgo, Flector
  • United Kingdom (Northern Ireland) · Dicloalgan, Flector Tissugel
  • Greece · Dicloplast, Miniflampatch
  • Hungary · Diclofenac Epolamine Cooper, Flector
  • Ireland · Diclofenac, Diclofenac Ibsa Farmaceutici Italia
  • Italy · Calminemed, Dicloreum
  • Luxembourg · Flector Tissugel
  • Poland · Diklofenak Viatris, Dolofest
  • Portugal · Diclofenac Farmoz, Flector Tissugel
  • Sweden · Flector
  • Slovakia · Flectopar, Flector

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/aadd1128-b7ae-42cd-9fb9-8bd5ac23f99b
GET /v1/drugs/aadd1128-b7ae-42cd-9fb9-8bd5ac23f99b?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": ".013",
  "substance": "DICLOFENAC EPOLAMINE",
  "productndc": "80425-0364",
  "dosage_form": "SYSTEM",
  "dea_schedule": null,
  "strength_unit": "g/1",
  "application_number": "NDA021234",
  "marketing_category": "NDA AUTHORIZED GENERIC"
}

See everything about diclofenac epolamine.

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.