United States· US:76162-336_4ab90806-7257-8b97-e063-6294a90a71c3

Calamine

A medicinal product containing ferric oxide red; pramoxine hydrochloride, registered in United States by Topco Associates 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…normalisedCalamineATC—REGISTER NO.US:76162-336_4ab90806…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE
Manufacturer
Topco Associates 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

  • ndc11
    76162-336-30
  • ndc11
    7616233630
    177 mL in 1 BOTTLE, PLASTIC (76162-336-30)

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/f04b52f8-35de-4e16-bc3e-995e2ce80e63
GET /v1/drugs/f04b52f8-35de-4e16-bc3e-995e2ce80e63?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": "80; 10",
  "substance": "FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE",
  "productndc": "76162-336",
  "dosage_form": "LOTION",
  "dea_schedule": null,
  "strength_unit": "mg/mL; mg/mL",
  "application_number": "M016",
  "marketing_category": "OTC MONOGRAPH DRUG"
}

See everything about ferric oxide red; pramoxine 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.