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United States· US:82645-910_0d1cdfd7-c2cf-9fd5-e063-6394a90a8eda

Earwax Removal Drops

A medicinal product containing carbamide peroxide, registered in United States by Pharma Nobis, LLC.

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…normalisedEarwax Removal DropsATC—REGISTER NO.US:82645-910_0d1cdfd7…PACKS LISTED4CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
CARBAMIDE PEROXIDE
Manufacturer
Pharma Nobis, 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 · 4

  • ndc11
    8264591045
    1 BOTTLE, DROPPER in 1 CARTON (82645-910-45) / 15 mL in 1 BOTTLE, DROPPER
  • ndc11
    8264591090
    1 CONTAINER in 1 CARTON (82645-910-90) / 15 mL in 1 CONTAINER
  • ndc11
    82645-910-45
  • ndc11
    82645-910-90

Regulatory notes

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

Same medicine, other countries

Carbamide peroxide in 3 other countries

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

All carbamide peroxide products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • United Kingdom (Northern Ireland) · Otex
  • Hungary · Hyperol
  • Ireland · Exterol

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/9442a8e0-2e28-4142-b468-23283b954387
GET /v1/drugs/9442a8e0-2e28-4142-b468-23283b954387?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": "AURICULAR (OTIC)",
  "source": "ndc",
  "strength": ".065",
  "substance": "CARBAMIDE PEROXIDE",
  "productndc": "82645-910",
  "dosage_form": "LIQUID",
  "dea_schedule": null,
  "strength_unit": "mg/mL",
  "application_number": "M014",
  "marketing_category": "OTC MONOGRAPH DRUG"
}

See everything about carbamide peroxide.

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.