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United States· US:42571-497_41be90a9-dfee-6fcc-e063-6394a90a4124

Proparacaine hydrochloride

A medicinal product containing proparacaine hydrochloride, registered in United States by Micro Labs Limited.

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…normalisedProparacaine hydrochlorideATC—REGISTER NO.US:42571-497_41be90a9…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
PROPARACAINE HYDROCHLORIDE
Manufacturer
Micro Labs Limited
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
    42571-497-57
  • ndc11
    4257149757
    1 BOTTLE in 1 CARTON (42571-497-57) / 15 mL in 1 BOTTLE

Regulatory notes

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

Same medicine, other countries

Proparacaine hydrochloride in 9 other countries

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

All proparacaine hydrochloride products

Authorised across Europe · EMA

The same active substance is authorised in 12 EEA countries. Names it is sold under:

  • Belgium · Alcaine
  • Bulgaria · Алкаин
  • Cyprus · Alcaine
  • Germany · Proparakain-Pos
  • United Kingdom (Northern Ireland) · Proxymetacaine Hydrochloride Minims Bausch & Lomb Uk
  • Greece · Alcaine
  • Ireland · Minims
  • Iceland · Alcaine
  • Lithuania · Alcaine
  • Norway · Alcaine
  • Poland · Alcaine
  • Slovenia · Alcaine

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/c671b512-724c-4e84-8245-4345909ca4e7
GET /v1/drugs/c671b512-724c-4e84-8245-4345909ca4e7?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": "5",
  "substance": "PROPARACAINE HYDROCHLORIDE",
  "productndc": "42571-497",
  "dosage_form": "SOLUTION/ DROPS",
  "dea_schedule": null,
  "strength_unit": "mg/mL",
  "application_number": "ANDA219294",
  "marketing_category": "ANDA"
}

See everything about proparacaine hydrochloride.

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.