United States· US:0065-0397_2fc4fc5f-9c4a-456e-9476-7791f6f9c3c1

Cyclogyl

A cyclopentolate product containing cyclopentolate hydrochloride, registered in United States by Alcon Laboratories, Inc.. The same ATC class is registered in 16 of our 19 countries.

ATC S01FA04US 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…normalisedCyclogylATCS01FA04REGISTER NO.US:0065-0397_2fc4fc5f…PACKS LISTED6CHECKEDSeptember 27, 2026

Where it is registered

Cyclopentolate is registered in 16 of 19 countries.

Countries holding a registration under ATC S01FA04 (cyclopentolate), each read from that country’s own register.

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

Cyclopentolate · ATC S01FA04

16 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Germany
  • Icelandprice
  • Ireland
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • Sweden
  • Switzerlandprice
  • United Kingdom
  • 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
CYCLOPENTOLATE HYDROCHLORIDE
Manufacturer
Alcon Laboratories, Inc.
Country
United States (US)
ATC code
S01FA04
ATC class
Cyclopentolate
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 6

  • ndc11
    0065039702
    1 BOTTLE, PLASTIC in 1 CARTON (0065-0397-02) / 2 mL in 1 BOTTLE, PLASTIC
  • ndc11
    0065039705
    1 BOTTLE, PLASTIC in 1 CARTON (0065-0397-05) / 5 mL in 1 BOTTLE, PLASTIC
  • ndc11
    0065039715
    1 BOTTLE, PLASTIC in 1 CARTON (0065-0397-15) / 15 mL in 1 BOTTLE, PLASTIC
  • ndc11
    0065-0397-02
  • ndc11
    0065-0397-05
  • ndc11
    0065-0397-15

Regulatory notes

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

Interactions

3 interactions on record for cyclopentolate.

Graded by severity as the source publishes them — 3 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

Cyclopentolate · interactions on record

3 records

  • 3 moderate

Most severe, free to view

  • PhenylephrineC01CA06moderate
  • PhysostigmineS01EB05moderate
  • PhysostigmineV03AB19moderate
  • 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

Cyclopentolate in 15 other countries

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

All cyclopentolate products

Authorised across Europe · EMA

The same active substance is authorised in 23 EEA countries. Names it is sold under:

  • Belgium · Cyclogyl, Minims Cyclopentolaathydrochloride Bausch + Lomb Ireland Limited
  • Bulgaria · Цикловижън
  • Cyprus · Cyclogyl
  • Czechia · Cyclopentolate Olikla
  • Germany · Cyclopentolat Alcon, Zyklolat Edo
  • Denmark · Cyclogyl
  • Spain · Colirofta Ciclopléjico
  • Finland · Oftan Syklo
  • France · Skiacol
  • Greece · Cyclogyl
  • Hungary · Humapent
  • Ireland · Minims
  • Iceland · Cyclogyl
  • Italy · Ciclolux, Plegik
  • Lithuania · Cyclogyl
  • Luxembourg · Minims, Minims Cyclopentolate Chlorhydrate Bausch + Lomb Ireland Limited
  • Malta · Minims Cyclopentolate Hydrochloride Bausch + Lomb Ireland
  • Netherlands · Cyclogyl, Minims Cyclopentolaathydrochloride Bausch + Lomb Ireland Limited
  • Norway · Cyclopentolat Bausch + Lomb Ireland Limited
  • Poland · Cykloftyal
  • Portugal · Cicloplegicedol, Midriodavi
  • Sweden · Cyclogyl, Cyclopentolat Bausch & Lomb
  • Slovakia · Cyclopentolate Olikla

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/0c6de4a5-51d2-4d74-b966-9757d02a775e
GET /v1/drugs/0c6de4a5-51d2-4d74-b966-9757d02a775e?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": "20",
  "substance": "CYCLOPENTOLATE HYDROCHLORIDE",
  "productndc": "0065-0397",
  "dosage_form": "SOLUTION/ DROPS",
  "dea_schedule": null,
  "strength_unit": "mg/mL",
  "application_number": "ANDA084108",
  "marketing_category": "ANDA"
}

See everything about cyclopentolate.

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.