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Estomaquil Polvo BISMUTH SUBSALICYLATE 262 mg Powder, 10 pouches — NDC 58988-1080-01 package photo

Estomaquil Polvo BISMUTH SUBSALICYLATE 262 mg Powder, 10 pouches

by ProMex LLC · 10 POUCH in 1 CARTON (58988-1080-1) / 1 POWDER in 1 POUCH
NDC 58988-1080-01
🏷️ FDA NDC (as labeled) 58988-1080-1 billing pads the package segment with a zero
This package
Contains10 pouches Pack sizes3 compare ↓
Also comes in: 20 pouches 58988-1080-02 50 pouches 58988-1080-03
OTC On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 58988-1080-1
Product NDC 58988-1080
11-digit billing NDC 58988108001
RxCUI 1721449, 1721455
UNII 62TEY51RR1
Application # M008
SPL Set ID cf94c99a-c489-45ec-bb13-3e6959e377de
Established class (EPC) Bismuth
Chemical class Bismuth
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2004-01-02
Route ORAL
Dosage form POWDER
Substance BISMUTH SUBSALICYLATE
Why two NDCs? The FDA registers this code as 58988-1080-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 58988-1080-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Bismuth class.

Pharmacologic class Bismuth
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerProMex LLC
FDA applicationM008 (OTC MONOGRAPH DRUG)
Labeler code58988
First marketedJan 2004
Product typeHuman Otc Drug
Portfolio5 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📖 What it is MedlinePlus · NLM

Bismuth subsalicylate is used to treat diarrhea, heartburn, and upset stomach in adults and children 12 years of age and older. Bismuth subsalicylate is in a class of medications called antidiarrheal agents. It works by decreasing the flow of fluids and electrolytes into the bowel, reduces inflammation within the intestine, and may kill the organisms that can cause diarrhea.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's used to calm a range of stomach and digestive problems — things like diarrhea, traveler's diarrhea, heartburn, indigestion, nausea, gas, belching, and that uncomfortable over-...
  • What is bismuth subsalicylate actually used for?
  • Don't panic — that's actually a very common and completely harmless side effect of bismuth subsalicylate. The medicine can temporarily turn your stool and even your tongue a dark o...
  • Why did my stool turn black after taking this? Should I be worried?
📖 Read our full Bismuth Subsalicylate guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII H0G9379FGK
    Calcium carbonate is a white mineral powder used as a filler and buffering agent in medicines. It helps give tablets their bulk and size while neutralizing stomach acid in some formulations.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII NBZ3QY004S
    Magnesium hydroxide is a mineral compound that acts as a buffer and pH adjuster in medications. It helps neutralize stomach acid and keeps the medicine at the right acidity level for stability and absorption.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 8MDF5V39QO
    A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.
  • UNII W4888I119H
    Tartaric acid is a natural organic acid found in grapes and tamarinds. In medicines, it works as a buffer to control acidity, an antioxidant to prevent spoilage, and sometimes a flavoring or binding agent.

7 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesanhydrous citric acid, calcium carbonate, magnesium hydroxide, maltodextrin, silicon dioxide, sodium bicarbonate, tartaric acid

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 20 pouches 50 pouches
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Estomaquil Polvo 262 mgthis 58988-1080-01 ProMex 10 pouches — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2004
On the market since
Jan 2004
📍
2026
Currently FDA-listed
22 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Estomaquil Polvo (this brand).

Top reported reactions

Nausea93
Vomiting76
Diarrhoea70
Abdominal Pain60
Pain53
Constipation48
Abdominal Distension43

Age at onset

Adolescent2
Adult39
Elderly48

Reporter sex

604 reports
Male · 44%
Female · 56%

Serious outcomes

Hospitalization264
Life-threatening51
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 54 23
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
58988-1080-01 You're viewing this 10 POUCH in 1 CARTON (58988-1080-1) / 1 POWDER in 1 POUCH 2004-01-02 Active
58988-1080-02 20 POUCH in 1 CARTON (58988-1080-2) / 1 POWDER in 1 POUCH 2004-01-02 Active
58988-1080-03 50 POUCH in 1 CARTON (58988-1080-3) / 1 POWDER in 1 POUCH 2004-01-02 Active

Pack size FAQ

What quantity is in NDC 58988-1080-01?
NDC 58988-1080-01 contains 10 pouches — 10 pouch in 1 carton / 1 powder in 1 pouch.
What is the difference between NDC 58988-1080-01 and NDC 58988-1080-02?
Both are Estomaquil Polvo BISMUTH SUBSALICYLATE 262 mg Powder — the drug itself is identical. NDC 58988-1080-01 is the 10 pouches package, while NDC 58988-1080-02 is the 20 pouches package.
What NDC number is used to bill for this package of Estomaquil Polvo BISMUTH SUBSALICYLATE 262 mg Powder?
Bill NDC 58988-1080-01 — the 11-digit billing format is 58988108001. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 58988-1080-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 58988-1080-01, written without dashes as 58988108001. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 58988-1080-01, the first segment (58988) is the labeler code FDA assigned to ProMex LLC; the middle segment (1080) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by ProMex LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 20 pouches (58988-1080-02), 50 pouches (58988-1080-03). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
ProMex LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 21 words ▾

Uses relieves: travelers' diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas belching fullness

⏱️ Dosage and Administration 72 words ▾

Directions Adults & Children 12 yrs and older: Dissolve 2 pouches (1 dose) in 1/2 glass of water. Repeat every 1/2 to 1 hour as needed, to a maximum of 8 doses in a 24-hour period use until diarrhea stops, but not more than 2 days. If symptoms persist, consult a doctor drink plenty of clear fluids to help prevent dehydration which may accompany diarrhea Children under 12 yrs: ask a doctor

⚠️ Warnings 190 words ▾

Warnings Reye`s syndrome Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea or vomiting occur, consult a doctor because these symptoms could be an early sign of Reye`s syndrome, a rare but serious illness Allergy alert Contains salicylate. Do not take if you are: allergic to salicylate (including aspirin) taking other salicylate products Do not use if you have an ulcer a bleeding problem Ask a doctor before use if you have fever mucus in the stool Ask a doctor or pharmacist before use if you are taking any drug for: anticoagulation (thinning the blood) diabetes gout arthritis When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur Stop use and ask a doctor if symptoms get worse ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days If pregnant or breast-feeding, ask a health professional before use.

Keep out of the reach of children. In case of overdose, seek professional help or contact a poison control center immediately

📦 Storage and Handling 17 words ▾

Other information each pouch contains: calcium 210 mg, magnesium 190 mg, sodium 206 mg avoid excessive heat

🧪 Active Ingredient 9 words ▾

Active ingredient (in each pouch) Bismuth Subsalicylate 262 mg

🧪 Inactive Ingredients 16 words ▾

Inactive ingredients anhydrous citric acid, calcium carbonate, magnesium hydroxide, maltodextrin, silicon dioxide, sodium bicarbonate, tartaric acid

🎯 Purpose 6 words ▾

Purpose Upset stomach reliever / Antidiarrheal

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 58987-0001-01 · Enos 58988-1100-01 · ProMex →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.