Home › NDC Lookup › Ingredients › Bismuth Subsalicylate 262 Mg › 72090-0053-01
💊image loading
(from DailyMed)

Upset Stomach Relief-Bismuth Subsalicylate 262 mg 262 mg Capsule, Liquid Filled, 48-count — NDC 72090-053-01 (Billing 72090-0053-01)

by Pioneer Life Sciences, LLC · 48 CAPSULE, LIQUID FILLED in 1 BOTTLE

This is a package of 48 capsules of Upset Stomach Relief-Bismuth Subsalicylate 262 mg 262 mg Capsule, Liquid Filled from Pioneer Life Sciences, LLC, marketed since Jun 2025 and currently FDA-listed. It is this product's only package size.

NDC 72090-0053-01
🏷️ FDA NDC (as labeled) 72090-053-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 72090-053-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
72090 labeler · 053 product · 01 package
Package marketed since
Jun 27, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0372090004740
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72090-053-01
Product NDC 72090-053
11-digit billing NDC 72090005301
RxCUI 2121072
UNII 62TEY51RR1
UPC 0372090004740
Application # M008
SPL Set ID 07e2cc82-ab0e-46c5-863b-67658b612678
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 2025-06-27
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance BISMUTH SUBSALICYLATE
Quick answers
  • RxCUI (RxNorm): 2121072
Why two NDCs? The FDA registers this code as 72090-053-01 — a 5-3-2 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 product segment → 72090-0053-01. 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.

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 relieves diarrhea, including traveler's diarrhea. It also helps with upset stomach after overindulging in food and drink, such as heartburn, indigestion, nausea, gas, belching a...
  • Use it only until the diarrhea stops, and no more than 2 days. If you're not better by then, or you get worse sooner, stop and see a doctor. Drink plenty of clear fluids while you...
  • That's a known, temporary and harmless effect of this medicine. But black stool can also signal bleeding, so do not use it if you already have bloody or black stool.
  • Children under 12 should be checked by a doctor first. Children and teens who have or are recovering from chicken pox or flu-like symptoms should not use it because of Reye's syndr...
📖 Read our full Bismuth Subsalicylate guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

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 mLPer 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.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
72090-0053-01 You're viewing this Main listing 48 CAPSULE, LIQUID FILLED in 1 BOTTLE 2025-06-27 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Bismuth subsalicylate 262 mg 35916-0234-01 Softgel 10 capsules — — FDA listed —
Pepto Bismol Liquicaps 262 mg 37000-0535-12 The 12 capsules — — FDA listed —
Pepto Bismol Diarrhea Liquicaps 262 mg 37000-0537-12 The 12 capsules — — Discontinued —
CVS Health Stomach Relief SOFTGEL 262 mg 51316-0829-22 CVS 12 capsules — — FDA listed —
RIGHT REMEDIES Stomach Relief BISMUTH SUBSALICYLATE 262 mg softgel 70692-0829-84 Strive 48 capsules — — FDA listed —
Upset Stomach Relief-Bismuth Subsalicylate 262 mgthis 72090-0053-01 Pioneer 48 capsules — — FDA listed —
FEVIA Diarrhea Control 262 mg 82706-0028-02 VIVUNT 24 capsules — — FDA listed —
Stomach Relief 262 mg 83059-0026-08 Shield 8 capsules — — Discontinued —
Stomach Relief 262 mg 83059-0111-08 Shield 8 capsules — — Discontinued —
Upset Stomach Relief-Bismuth Subsalicylate 262 mg 84324-0028-01 NUVICARE 30 capsules — — FDA listed —
nexmed multi symptom stomach relief 262 mg 83059-0092-01 Shield 105 capsules — — 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

🏛️
2025
On the market since
Jun 2025
📍
2026
Currently FDA-listed
1 year 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.

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.

🧪 Avoiding an ingredient? See Bismuth Subsalicylate inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII 9DBA0SBB0L
    A synthetic red dye derived from coal tar used as a colorant in medicines and cosmetics. It gives tablets, capsules, and liquids their red or pink appearance for identification and visual appeal.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
  • UNII 6O92ICV9RU
    A waxy substance derived from sorbitol that helps mix oil and water together in medicines. It's used as an emulsifier to keep ingredients evenly blended and stable.
  • UNII 8KW3E207O2
    A liquid sweetener made from sorbitol, a sugar alcohol derived from glucose. It sweetens the medicine and also acts as a humectant to help retain moisture and improve texture in liquid formulations.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

The official label also statesPolyethylene Glycol-400, Polysorbate 80, Soya Lecithin, Povidone (PVPK 30), Gelatin, Glycerin, Sorbitol Sorbitan Solution, D & C Red 33, Titanium Dioxide, Purified Water

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.

Manufacturer & labeler

LabelerPioneer Life Sciences, LLC
FDA applicationM008 (OTC MONOGRAPH DRUG)
Labeler code72090
First marketedJun 2025
Product typeHuman Otc Drug
Portfolio65 products on file

More NDCs from Pioneer Life Sciences, LLC labeler code 72090

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.

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 30 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 92 words ▾

Directions ■ swallow with water, do not chew ■ adults and children 12 years and over: ■ 2 softgels every ½ hour or 4 softgels every hour as needed for diarrhea ■ 2 softgels every ½ hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) ■ do not exceed 8 doses (16 softgels) in 24 hours ■ use until diarrhea stops but not more than 2 days ■ children under 12 years: ask a doctor ■ drink plenty of clear fluids to help prevent dehydration caused by diarrhea

⚠️ Warnings 74 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 and 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 salicylates (including aspirin) ■ taking other salicylate products

🧪 Active Ingredient 9 words ▾

Active Ingredient (in each softgel) Bismuth subsalicylate 262 mg

🧪 Inactive Ingredients 26 words ▾

Inactive ingredients Polyethylene Glycol-400, Polysorbate 80, Soya Lecithin, Povidone (PVPK 30), Gelatin, Glycerin, Sorbitol Sorbitan Solution, D & C Red 33 , Titanium Dioxide, Purified Water

🎯 Purpose 6 words ▾

Purpose Upset stomach reliever and antidiarrheal

📄 Do Not Use 18 words ▾

Do not use if you have ■ an ulcer ■ a bleeding problem ■ bloody or black stool

📄 Ask a Doctor Before Use If 15 words ▾

Ask a doctor before use if you have ■ fever ■ mucus in the stool

📄 Ask a Doctor or Pharmacist Before Use If 25 words ▾

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 16 words ▾

When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur

📄 Stop Use and Ask a Doctor If 34 words ▾

Stop use and ask a doctor if ■ symptoms get worse or last more than 2 days ■ ringing in the ears or loss of hearing occurs ■ diarrhea lasts more than 2 days

🤰 If Pregnant or Breast-Feeding 11 words ▾

If pregnant or breast feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 22 words ▾

KEEP OUT OF REACH OF CHILDREN In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

📄 Questions or Comments 10 words ▾

Questions or Comments? Call +1 (732) 994-2808 or email [email protected]

📄 Package Label / Principal Display Panel 6 words ▾

PL0275-00 GC Bismuth Subsalicylate Softgels 48ct

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 — Not published for this NDC No photo available yet for this listing.
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Pioneer Life Sciences, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Pioneer Life Sciences, 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.
← 72090-0052-01 · Pioneer 72090-0054-01 · Pioneer →
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.