United States· US:58988-1080_b60909fc-e262-4ad4-bb96-e09b71b38e1c
Estomaquil Polvo
A medicinal product containing bismuth subsalicylate, registered in United States by ProMex LLC.
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
- BISMUTH SUBSALICYLATE
- Manufacturer
- ProMex 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 · 6
- ndc1158988-1080-3
- ndc11589881080110 POUCH in 1 CARTON (58988-1080-1) / 1 POWDER in 1 POUCH
- ndc11589881080220 POUCH in 1 CARTON (58988-1080-2) / 1 POWDER in 1 POUCH
- ndc11589881080350 POUCH in 1 CARTON (58988-1080-3) / 1 POWDER in 1 POUCH
- ndc1158988-1080-1
- ndc1158988-1080-2
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Bismuth subsalicylate in 3 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CanadaBISMUTH CAPLETSJUNO OTC INC
- United KingdomBoots Pepti-Calm 525.6mg/30ml oral suspensionThe Boots Company Plc
- NorwayBismuth Subsalicylate majorMajor Pharmaceuticals
Authorised across Europe · EMA
The same active substance is authorised in 2 EEA countries. Names it is sold under:
- United Kingdom (Northern Ireland) · Pepti-Calm, Pepto-Bismol
- Hungary · Intestal
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/c8f8448b-9c2c-47a4-83d1-3f7e017a19da GET /v1/drugs/c8f8448b-9c2c-47a4-83d1-3f7e017a19da?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": "262",
"substance": "BISMUTH SUBSALICYLATE",
"productndc": "58988-1080",
"dosage_form": "POWDER",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "M008",
"marketing_category": "OTC MONOGRAPH DRUG"
}See everything about bismuth subsalicylate.
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.