United States· US:0998-0016_5468200d-d85e-4e90-928b-84a91e05185b

Alcaine

A proxymetacaine product containing proparacaine hydrochloride, registered in United States by Alcon Laboratories, Inc.. The same ATC class is registered in 10 of our 19 countries.

ATC S01HA04Orange BookUS label

Checked against FDA National Drug Code directory (United States) on June 3, 2026

Informational only — not a medical device.

Compare price across countriesPer daily dose · free account Ask the assistant about proparacaine hydrochlorideAnswers with sources · free account Check interactionsSeverity free · mechanism on Growth

Where it is registered

Proxymetacaine is registered in 10 of 19 countries.

Countries holding a registration under ATC S01HA04 (proxymetacaine), 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

Search proxymetacaine products by name

Proxymetacaine · ATC S01HA04

10 / 19 countries

Belgiumprice
Canada
Germany
Icelandprice
Ireland
Norwayprice
Polandprice
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: proparacaine hydrochloride
Manufacturer: Alcon Laboratories, Inc.
Country: United States (US)
ATC code: S01HA04
ATC class: Proxymetacaine
Reimbursed: Not published by this register
Source register: FDA National Drug Code directory (United States)
Last checked: June 3, 2026

Packs & prices · 1

ndc11
0998001615
1 BOTTLE in 1 CARTON (0998-0016-15) / 15 mL in 1 BOTTLE

Regulatory notes

UNII (FDA substance ID)

U96OL57GOY

PROPARACAINE HYDROCHLORIDE

RxCUI 227778

Orange Book

A080027

DailyMed SPL labels

1 version tracked

Interactions

20 interactions on record for proxymetacaine.

Graded by severity as the source publishes them — 20 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

Check proxymetacaine against other medicines How interaction checks work

Proxymetacaine · interactions on record

20 records

20 moderate

Most severe, free to view

MetoclopramideA03FA01moderate
SulfamethizoleB05CA04moderate
LidocaineC01BB01moderate
Silver sulfadiazineD06BA01moderate

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

Proxymetacaine in 9 other countries

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

All proxymetacaine 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/6ec655b0-c212-4fa4-bdce-c22d23d3fe14
GET /v1/drugs/6ec655b0-c212-4fa4-bdce-c22d23d3fe14?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.

{
  "unii": {
    "unii": "U96OL57GOY",
    "rxcui": "227778",
    "inchikey": "BFUUJUGQJUTPAF-UHFFFAOYSA-N",
    "display_name": "PROPARACAINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "0c0fa0bf-977d-4539-b8dc-54c187c5b094": {
      "match": "brand_token",
      "title": "ALCAINE (PROPARACAINE HYDROCHLORIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]",
      "spl_version": "11",
      "published_date": "2024-07-22"
    }
  },
  "productid": "0998-0016_5468200d-d85e-4e90-928b-84a91e05185b",
  "productndc": "0998-0016",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "080027",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "0.5%",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PROPARACAINE HYDROCHLORIDE",
  "proprietary_name": "Alcaine",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA080027",
  "marketing_category": "ANDA",
  "nonproprietary_name": "proparacaine hydrochloride",
  "start_marketing_date": "19731019",
  "active_numerator_strength": "5"
}

API reference MCP server Plans

See everything about proxymetacaine.

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.

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