United States· US:82584-792_50281c7f-d484-86d7-e063-6394a90af6ff

AKTEN

A lidocaine product containing lidocaine hydrochloride anhydrous, registered in United States by Thea Pharma Inc.. The same ATC class is registered in 8 of our 19 countries.

ATC S01HA07US 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…normalisedAKTENATCS01HA07REGISTER NO.US:82584-792_50281c7f…PACKS LISTED4CHECKEDSeptember 27, 2026

Where it is registered

Lidocaine is registered in 8 of 19 countries.

Countries holding a registration under ATC S01HA07 (lidocaine), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 6 of them publish a price we can compare per daily dose

Lidocaine · ATC S01HA07

8 / 19 countries

  • Belgiumprice
  • Denmark
  • Finlandprice
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
LIDOCAINE HYDROCHLORIDE ANHYDROUS
Manufacturer
Thea Pharma Inc.
Country
United States (US)
ATC code
S01HA07
ATC class
Lidocaine
Defined daily dose
1 Eindosisbeh
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 4

  • ndc11
    8258479201
    1 TUBE in 1 CARTON (82584-792-01) / 1 mL in 1 TUBE
  • ndc11
    8258479225
    25 TUBE in 1 CARTON (82584-792-25) / 1 mL in 1 TUBE
  • ndc11
    82584-792-01
  • ndc11
    82584-792-25

Regulatory notes

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

Interactions

38 interactions on record for lidocaine.

Graded by severity as the source publishes them — 38 moderate. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan

Lidocaine · interactions on record

38 records

  • 38 moderate

Most severe, free to view

  • MetoclopramideA03FA01moderate
  • SulfamethizoleB05CA04moderate
  • Glyceryl trinitrateC01DA02moderate
  • Isosorbide dinitrateC01DA08moderate
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Lidocaine in 16 other countries

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

All lidocaine products

Authorised across Europe · EMA

The same active substance is authorised in 31 EEA countries. Names it is sold under:

  • Austria · Cathejell, Dynexan
  • Belgium · Instillido, Lidocaine Aguettant
  • Bulgaria · Instillido, Lidocaine Hydrochloride Monohydrate Чайкафарма
  • Cyprus · Lidocaine Apta, Lidocaine Hydrochloride Noridem
  • Czechia · Lidocain Egis, Lidocaine Egis
  • Germany · Acoin, Actilogic
  • Denmark · Instillido, Lidbree
  • Estonia · Instillido, Lidocaine Accord
  • Spain · Actilogic, Dermovagisil
  • Finland · Esliva, Instillido
  • France · Chlorhydrate De Lidocaine Renaudin, Dynexan
  • United Kingdom (Northern Ireland) · Boots Severe Sore Throat Relief, Chloradirect Severe Sore Throat Relief
  • Greece · Carmelido, Consolid
  • Croatia · Dolokain, Instillido
  • Hungary · Lidocain Egis, Lidocain-Egis
  • Ireland · Dolocopin, Lidocaine Hydrochloride
  • Iceland · Lidocaine Grindeks, Lidokain Viatris
  • Italy · Asensil, Basicaina
  • Liechtenstein · Lidocain Walter Ritter
  • Lithuania · Instillido, Lidocain-Egis
  • Luxembourg · Dynexan Gel, Lidocain Braun
  • Latvia · Lidocaine Baxter, Lidocaine Egis
  • Malta · Lidocaine Hydrochloride Bp B. Braun Melsungen, Lidonostrum
  • Netherlands · Dynexan Mondgel, Instillido
  • Norway · Instillido, Lidocaine Accord
  • Poland · Bobodent, Bravera Control
  • Portugal · Lambdalina, Lidbree
  • Romania · Instillido, Lidocain
  • Sweden · Instillagel, Instillido
  • Slovenia · Instillido, Lidokain Kabi
  • Slovakia · Lidocain Egis, Lidocaine Noridem

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/0fd2ab7f-92d5-4e8b-bee4-fc10369128ef
GET /v1/drugs/0fd2ab7f-92d5-4e8b-bee4-fc10369128ef?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": "OPHTHALMIC",
  "source": "ndc",
  "strength": "35",
  "substance": "LIDOCAINE HYDROCHLORIDE ANHYDROUS",
  "productndc": "82584-792",
  "dosage_form": "GEL",
  "dea_schedule": null,
  "strength_unit": "mg/mL",
  "application_number": "NDA022221",
  "marketing_category": "NDA"
}

See everything about lidocaine.

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.