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United States· US:58602-868_cbeb5700-40fc-4140-862f-661f864ecd25

Loperamide Hydrochloride and Simethicone

A other ectoparasiticides, incl. scabicides product containing loperamide hydrochloride and simethicone, registered in United States by Aurohealth LLC. The same ATC class is registered in 3 of our 19 countries.

ATC P03AXOrange BookUS 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…normalisedLoperamide Hydrochloride and Simethic…ATCP03AXREGISTER NO.US:58602-868_cbeb5700…PACKS LISTED1CHECKEDJune 3, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about loperamide hydrochloride and simethiconeAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Loperamide hydrochloride and simethicone is registered in 3 of 19 countries.

Countries holding a registration under ATC P03AX (other ectoparasiticides, incl. scabicides), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 2 of them publish a price we can compare per daily dose
Search loperamide hydrochloride and simethicone products by name

Loperamide hydrochloride and simethicone · ATC P03AX

3 / 19 countries

  • Canada
  • Polandprice
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
Loperamide Hydrochloride and Simethicone
Manufacturer
Aurohealth LLC
Country
United States (US)
ATC code
P03AX
ATC class
Other ectoparasiticides, incl. scabicides
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
June 3, 2026

Packs & prices · 1

  • ndc11
    5860286876
    4 BLISTER PACK in 1 CARTON (58602-868-76) / 6 TABLET in 1 BLISTER PACK

Regulatory notes

Orange Book
A211059
DailyMed SPL labels
1 version tracked

Same class

Other records under P03AX

Other ectoparasiticides, incl. scabicides, as other registers publish it.

All loperamide hydrochloride and simethicone products

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/dc4d440e-fc6f-4be6-9922-c968e3c2021a
GET /v1/drugs/dc4d440e-fc6f-4be6-9922-c968e3c2021a?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": "ORAL",
  "spl_meta": {
    "0b1f8d41-51b3-4362-8de7-46bca5caff12": {
      "match": "brand_token",
      "title": "LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SOLUTION [PREFERRED PHARMACEUTICALS INC.]",
      "spl_version": "6",
      "published_date": "2026-06-01"
    }
  },
  "productid": "58602-868_cbeb5700-40fc-4140-862f-661f864ecd25",
  "productndc": "58602-868",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "211059",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2MG;125MG",
        "product_no": "001",
        "approval_date": "Dec 14, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DIMETHICONE; LOPERAMIDE HYDROCHLORIDE",
  "proprietary_name": "Loperamide Hydrochloride and Simethicone",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA211059",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Loperamide Hydrochloride and Simethicone",
  "start_marketing_date": "20210224",
  "active_numerator_strength": "125; 2"
}
API referenceMCP serverPlans

See everything about loperamide hydrochloride and simethicone.

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.

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