United States· US:0904-7478_1f7fbab4-f5a2-0187-e063-6394a90afba1
Major Earwax Removal Drops Earwax Removal Aid
A medicinal product containing carbamide peroxide, registered in United States by Major Pharmaceuticals.
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
- CARBAMIDE PEROXIDE
- Manufacturer
- Major Pharmaceuticals
- 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
- ndc1109047478351 BOTTLE in 1 BOX (0904-7478-35) / 15 mL in 1 BOTTLE
- ndc110904-7478-35
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.
- United KingdomExterol 5% ear dropsDermal Laboratories Ltd
- CanadaEAROXIDE LIQ 6.5%TOMLYN PRODUCTS DIVISION OF VETOQUINOL USA INC.
- IrelandExterol 5% w/w Ear Drops, SolutionDermal Laboratories (Ireland) Limited
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/e979884c-a522-4df5-9e08-d2df564511b0 GET /v1/drugs/e979884c-a522-4df5-9e08-d2df564511b0?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": "TOPICAL",
"source": "ndc",
"strength": "65",
"substance": "CARBAMIDE PEROXIDE",
"productndc": "0904-7478",
"dosage_form": "SOLUTION/ DROPS",
"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.