Bismuth Subsalicylate 262 mg Tablet, Film Coated, 24-count
by LEADER/ Cardinal Health 110, Inc. · 1 BOTTLE in 1 CARTON (70000-0594-1) / 24 TABLET, FILM COATED in 1 BOTTLE
NDC 70000-0594-01
🏷️ FDA NDC (as labeled)
70000-0594-1
billing pads the package segment with a zero
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 →
🆔 Identity & classification
FDA NDC (as labeled)
70000-0594-1
Product NDC
70000-0594
11-digit billing NDC
70000059401
NCPDP billing unit
EA — each (per item)
RxCUI
308760
UNII
62TEY51RR1
UPC
0096295141375
Application #
M008
SPL Set ID
d4af6694-910c-da17-e053-2995a90a8454
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
2022-01-03
Route
ORAL
Dosage form
TABLET, FILM COATED
Substance
BISMUTH SUBSALICYLATE
GPI-14
47300010000307
GCN Seq No
023160
GCN
08421
HICL code
001246
Ingredient (HICL)
Bismuth Subsalicylate
HIC1 code
D
Therapeutic class — broad (HIC1)
Biliary System/Gastro-Intestinal System
HIC2 code
D6
Therapeutic class — intermediate (HIC2)
Drugs Acting Principally On The Colon
HIC3 code
D6D
Therapeutic class — specific (HIC3)
Antidiarrheals
AHFS code
56:04.00.00
AHFS class
Antacids And Adsorbents
FDB label name
STOMACH RELIEF 262 MG CAPLET
FDB brand name
Stomach Relief
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 70000-0594-1 — 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 → 70000-0594-01. 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
LabelerLEADER/ Cardinal Health 110, Inc.
FDA applicationM008 (OTC MONOGRAPH DRUG)
Labeler code70000
First marketedJan 2022
Product typeHuman Otc Drug
Portfolio38 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
Label name STOMACH RELIEF 262 MG CAPLET Ingredient Bismuth Subsalicylate
📖 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 a go-to remedy for diarrhea — including traveler's diarrhea — and for upset stomach when you've eaten or drunk too much. That covers heartburn, indigestion, nausea, gas, belch...
- What exactly does bismuth subsalicylate help with?
- Completely normal, and nothing to worry about. Bismuth reacts with trace amounts of sulfur in your digestive tract and saliva, which temporarily turns things dark — sometimes black...
- Why did my stool and tongue turn dark after taking this?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Bismuth Subsalicylate (OTC drug) — tap one for details:
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.
💬 Questions about Bismuth Subsalicylate?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
white
ShapeOval
ImprintV
Size17 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.
🧪 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 M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
-
UNII 2S7830E561
Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
-
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
-
UNII N6K5787QVP
Light mineral oil is a clear, odorless liquid derived from petroleum. In medicines, it acts as a lubricant and emollient to help the product spread smoothly and improve texture.
-
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
-
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
-
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 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 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
-
UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
-
UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
-
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 XHX3C3X673
Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.
13 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statescroscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, silica, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin.
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 system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.093 | $2.23 / 24 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.2875 | $6.90 / 24 tablets |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
NADAC price history (per ea) — tap or hover for the price & month
▲ Up 30% over the last 14 months.
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| GNP Pink Bismuth 262 mg 24385-0017-58 | Amerisource | 40 tablets | $0.093 | — | Availability likely | — |
| Bismuth Subsalicylate 262 mgthis 70000-0594-01 | LEADER/ | 24 tablets | $0.093 | — | Availability likely | — |
| Foster and Thrive Stomach Relief 262 mg 70677-1082-01 | Strategic | 40 tablets | $0.093 | — | Availability likely | — |
| Stomach Relief 262 mg 83324-0060-40 | Chain | 40 tablets | $0.093 | — | Availability likely | — |
| Walgreen 262 mg 00363-9125-40 | WALGREEN | 40 tablets | — | — | FDA listed | — |
| up and up 5-symptom digestive relief 262 mg 11673-0122-48 | Target | 48 tablets | — | — | FDA listed | — |
| up and up 5-symptom digestive relief 262 mg 11673-0125-20 | Target | 40 tablets | — | — | FDA listed | — |
| 5-Symptom Digestive Relief 262 mg 11673-0880-44 | TARGET | 40 tablets | — | — | FDA listed | — |
| Rite Aid Digestive Relief 262 mg 11822-1254-00 | RITE | 40 tablets | — | — | FDA listed | — |
| Digestive Relief 262 mg 21130-0125-40 | SAFEWAY | 40 tablets | — | — | FDA listed | — |
| Kroger Digestive Relief 262 mg 30142-0524-24 | KROGER | 24 tablets | — | — | FDA listed | — |
| Topco Stomach Relief 262 mg 36800-0104-28 | Topco | 40 tablets | — | — | FDA listed | — |
| Stomach Relief 262 mg 37808-0346-08 | H | 24 tablets | — | — | FDA listed | — |
| Equaline Stomach Relief 262 mg 41163-0123-28 | UNITED | 40 tablets | — | — | FDA listed | — |
| meijer stomach relief 262 mg 41250-0324-40 | Meijer | 40 tablets | — | — | FDA listed | — |
| Stomach reliever 262 mg 42507-0707-28 | Hyvee | 40 tablets | — | — | FDA listed | — |
| Stomach Relief 262 mg 49035-0346-10 | Wal-Mart | 40 tablets | — | — | FDA listed | — |
| Kaopectate 262 mg 55505-0197-07 | Kramer | 28 tablets | — | — | FDA listed | — |
| POCKET PEPTO Pepto Bismol 262 mg 58933-0017-12 | Procter | 12 tablets | — | — | FDA listed | — |
| Pepto-Bismol 262 mg 58933-0476-01 | Procter | 2 tablets | — | — | FDA listed | — |
| QC Pink Bismuth 262 mg 63868-0171-40 | QUALITY | 40 tablets | — | — | FDA listed | — |
| Stomach Relief 262 mg 63868-0691-40 | CHAIN | 40 tablets | — | — | Discontinued | — |
| Anti-Diarrheal 262 mg 66715-6841-04 | Lil' | 24 tablets | — | — | FDA listed | — |
| Stomach relief 262 mg 69842-0172-12 | CVS | 24 tablets | — | — | FDA listed | — |
| Bismuth Subsalicylate 262 mg 69842-0346-12 | CVS | 24 tablets | — | — | FDA listed | — |
| AMAZON Digestive Relief 262 mg 72288-0125-40 | AMAZON.COM | 40 tablets | — | — | FDA listed | — |
| Pepto-Bismol 262 mg 76420-0490-24 | ASCLEMED | 24 tablets | — | — | FDA listed | — |
| Stomach Relief 262 mg 63868-0622-30 | CDMA- | 30 tablets | — | — | FDA listed | — |
| Topcare Stomach Relief Original Strength 262 mg 76162-0001-85 | TopCo | 30 tablets | — | — | FDA listed | — |
| CVS Stomach Relief 262 mg 51316-0124-48 | CVS | 48 tablets | — | — | FDA listed | — |
| Bismuth 262 mg 69168-0046-69 | Allegiant | 12 tablets | — | — | FDA listed | — |
| Stomach Relief 262 mg 41226-0475-42 | Kroger | 24 tablets | — | — | 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
🏛️
2022
On the market since
Jan 2022
📍
2026
Currently FDA-listed
4 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.
🗺️ Medicaid utilization & spend
📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 70000-0594-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
292
Units reimbursed last 4 qtrs
17.5K
Gross reimbursed last 4 qtrs
$5K
Avg / prescription
$17.25
Avg / unit
$0.2875
Latest quarter Q1 2026
89Rx
Medicaid pays / ea
$0.2875
gross reimbursed
vs
NADAC / ea
$0.0930
acquisition cost
=
Spread
+$0.1945
+209% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
Fee-for-service · 228 Rx Managed care · 64 Rx
State Medicaid map
Units reimbursed · per 100k residents
4.932.4
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
🔬 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 Bismuth Subsalicylate — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 38%
Female · 62%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 70000-0594-01 You're viewing this | 1 BOTTLE in 1 CARTON (70000-0594-1) / 24 TABLET, FILM COATED in 1 BOTTLE | 2022-01-03 | Active |
📄 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
🆘 Overdosage
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses relieves: ■ travelers’ diarrhea ■ diarrhea ■ upset stomach due to overindulgence in food and drink, including: ■ heartburn ■ indigestion ■ nausea ■ gas ■ belching ■ fullness
⏱️ Dosage and Administration ▾
Directions swallow caplets with water, do not chew adults and children 12 years and over : 2 caplets (1 dose) every 1/2 hour or 4 caplets (2 doses) every hour as needed for diarrhea 2 caplets (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) do not exceed 8 doses (16 caplets) 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 ▾
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. Do not use if you have an ulcer a bleeding problem bloody or black stool 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 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, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
🆘 Overdosage ▾
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
🧪 Active Ingredient ▾
Drug Facts Active ingredient (in each caplet) Bismuth subsalicylate 262 mg
🧪 Inactive Ingredients ▾
croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, silica, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin.
🎯 Purpose ▾
Purpose Upset stomach reliever and antidiarrheal
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.