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United States· US:64616-050_462ed52e-9da2-6cc3-e063-6294a90ad318

Pediatric Earache Remedy

A medicinal product containing aconitum napellus; atropa belladonna; potassium chloride; plantago major; matricaria recutita; verbascum thapsus, registered in United States by Vitality Works, Inc.

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…normalisedPediatric Earache RemedyATC—REGISTER NO.US:64616-050_462ed52e…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
ACONITUM NAPELLUS; ATROPA BELLADONNA; POTASSIUM CHLORIDE; PLANTAGO MAJOR; MATRICARIA RECUTITA; VERBASCUM THAPSUS
Manufacturer
Vitality Works, Inc
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
    64616-050-02
  • ndc11
    6461605002
    1 BOTTLE, DROPPER in 1 CARTON (64616-050-02) / 15 mL in 1 BOTTLE, DROPPER (64616-050-01)

Regulatory notes

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

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/cb1ad950-26fb-4f4c-a295-5e07cff48d11
GET /v1/drugs/cb1ad950-26fb-4f4c-a295-5e07cff48d11?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": "6; 3; 3; 3; 6; 6",
  "substance": "ACONITUM NAPELLUS; ATROPA BELLADONNA; POTASSIUM CHLORIDE; PLANTAGO MAJOR; MATRICARIA RECUTITA; VERBASCUM THAPSUS",
  "productndc": "64616-050",
  "dosage_form": "LIQUID",
  "dea_schedule": null,
  "strength_unit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
  "application_number": null,
  "marketing_category": "UNAPPROVED HOMEOPATHIC"
}

See everything about aconitum napellus; atropa belladonna; potassium chloride; plantago major; matricaria recutita; verbascum thapsus.

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.