United States· US:54288-127_df1a3d1f-8d9c-4ae6-9cad-527680105425
Tetracaine HCL
A medicinal product containing tetracaine hydrochloride, registered in United States by BPI LABS LLC.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- TETRACAINE HYDROCHLORIDE
- Manufacturer
- BPI LABS 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
- ndc11542881271010 VIAL in 1 BOX (54288-127-10) / 2 mL in 1 VIAL (54288-127-01)
- ndc1154288-127-10
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Tetracaine hydrochloride in 12 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomAmetop 4% gelAlliance Pharmaceuticals Ltd
- BelgiumHexomedine 1 mg/g - 0.5 mg/gMelisana
- NorwayAmetopAlliance Pharmaceuticals
- SpainANESTESIA TOPICA B. BRAUN 10 mg/ml SOLUCIONB Braun Medical S.A.
- IrelandAmetop 40 mg/g GelAlliance Pharma (Ireland) Limited
- CanadaAMETOP GEL 4%VALEO PHARMA INC
- NetherlandsMinims Tetracainehydrochloride 10 mg/ml, oogdruppels, oplossingBausch + Lomb Ireland Limited
- FinlandMinims AmethocaineChauvin Pharmaceuticals Limited
Authorised across Europe · EMA
The same active substance is authorised in 11 EEA countries. Names it is sold under:
- Belgium · Minims Tetracaine Chlorhydrate Bausch + Lomb Ireland Limited, Minims Tetracainehydrochloride Bausch + Lomb Ireland Limited
- Germany · Tetracain-Hcl Smartpractice Europe
- Spain · Lubristesic, Tetracaína Lainco
- France · Tetracaine Thea
- United Kingdom (Northern Ireland) · Ametop, Anethaine
- Greece · Tetracaine Hydrochloride Cooper
- Ireland · Ametop, Minims
- Luxembourg · Minims, Minims Tetracaine Chlorhydrate Bausch + Lomb Ireland Limited
- Netherlands · Minims Tetracainehydrochloride, Tetracaïnehydrochloride Minims Bausch + Lomb Ireland
- Norway · Tetrakain Minims Bausch + Lomb Ireland Limited
- Sweden · Tetrakain Bausch & Lomb
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/81f4740a-ef9b-4b66-af34-a4d7a75e3644 GET /v1/drugs/81f4740a-ef9b-4b66-af34-a4d7a75e3644?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": "SUBARACHNOID",
"source": "ndc",
"strength": "10",
"substance": "TETRACAINE HYDROCHLORIDE",
"productndc": "54288-127",
"dosage_form": "INJECTION",
"dea_schedule": null,
"strength_unit": "mg/mL",
"application_number": null,
"marketing_category": "UNAPPROVED DRUG OTHER"
}See everything about tetracaine 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.