United States· US:54738-518_5cc86981-732a-038f-e053-2991aa0a19d4
Simethicone
A medicinal product containing dimethicone, registered in United States by Richmond Pharmaceuticals, Inc..
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
- DIMETHICONE
- Manufacturer
- Richmond Pharmaceuticals, 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
- ndc115473851801100 TABLET, CHEWABLE in 1 BOTTLE (54738-518-01)
- ndc1154738-518-01
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Dimethicone in 6 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FinlandCeolatSolvay Pharmaceuticals GmbH
- United KingdomBoots Lip & Cold Sore creamThe Boots Company Plc
- CanadaBAZA CLEANSE & PROTECTCOLOPLAST A/S
- PolandEsputiconPrzedsiębiorstwo Farmaceutyczno-Chemiczne "Synteza" Sp. z o.o.
- FrancePOLYSILANE UPSA, gel oral en sachet-doseUPSA
- GermanySab SimplexPfizer Pharma Gmbh
Authorised across Europe · EMA
The same active substance is authorised in 6 EEA countries. Names it is sold under:
- Germany · Sab Simplex
- Finland · Cuplaton
- France · Polysilane
- United Kingdom (Northern Ireland) · Hedrin
- Ireland · Dentinox Infant Colic Drops
- Poland · Esputicon
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/da7590f1-00c7-4e2a-9731-60e66cf9ea2d GET /v1/drugs/da7590f1-00c7-4e2a-9731-60e66cf9ea2d?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",
"source": "ndc",
"strength": "80",
"substance": "DIMETHICONE",
"productndc": "54738-518",
"dosage_form": "TABLET, CHEWABLE",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "part332",
"marketing_category": "OTC MONOGRAPH FINAL"
}See everything about dimethicone.
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.