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Bismuth 262 mg Tablet, 12-count — NDC 69168-0046-69 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Bismuth 262 mg Tablet, 12-count — NDC 69168-046-69 (Billing 69168-0046-69)

by Allegiant Health · 12 TABLET in 1 CELLO PACK

This is a package of 12 tablets of Bismuth 262 mg Tablet from Allegiant Health, marketed since Dec 2014 and currently FDA-listed.

NDC 69168-0046-69
🏷️ FDA NDC (as labeled) 69168-046-69 billing pads the product segment with a zero
This package
Contains12-count Pack sizes5 compare ↓
Product page 69168-0046-32 Also comes in: 30 tablets 69168-046-88 50 tablets 69168-046-50 100 tablets 69168-046-32 200 tablets 69168-046-98
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69168-046-69
Product NDC 69168-046
11-digit billing NDC 69168004669
RxCUI 308761
UNII 62TEY51RR1
Application # M008
SPL Set ID 015ca07a-f6b5-4741-a7b0-821cf6d4e418
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 2014-12-23
Route ORAL
Dosage form TABLET
Substance BISMUTH SUBSALICYLATE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 002860
GCN 08420
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 BISMUTH 262 MG TABLET CHEW
FDB brand name Bismuth
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 002860
  • GCN: 08420
  • HICL (First Databank): 001246
  • AHFS class code: 56:04.00.00
  • RxCUI (RxNorm): 308761
Why two NDCs? The FDA registers this code as 69168-046-69 — 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 → 69168-0046-69. 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

Label name BISMUTH 262 MG TABLET CHEW Ingredient Bismuth Subsalicylate
📗 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 →
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 eachPer 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: 30 tablets 50 tablets 100 tablets 200 tablets
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
69168-0046-69 You're viewing this 12 TABLET in 1 CELLO PACK 2014-12-23 — Active
69168-0046-88 69168-046-88 30 TABLET in 1 CELLO PACK 2014-12-23 — Active
69168-0046-32 69168-046-32 Main listing 100 TABLET in 1 BOTTLE 2023-05-31 — Active
69168-0046-50 69168-046-50 50 TABLET in 1 BOTTLE 2023-11-06 — Active
69168-0046-98 69168-046-98 200 TABLET in 1 BOTTLE 2026-05-07 — Active

You're viewing the smallest of 5 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 12-count package — 12 tablet in 1 cello pack.
How does this package differ from NDC 69168-0046-88?
Both are Bismuth 262 mg Tablet — the drug itself is identical. This page's package is the 12-count one, while NDC 69168-0046-88 is the 30 tablets package.
What NDC number is used to bill for this package of Bismuth 262 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Major Bismuth Subsalicylate 262 mg 00904-7205-46 Major 6 tablets $0.082 — Availability likely —
GNP Pink Bismuth 262 mg 46122-0701-65 Amerisource 6 tablets $0.082 — Availability likely —
McKesson Bismuth 262 mg 68599-4744-07 McKesson 2 tablets $0.082 — Availability likely —
Foster and Thrive Stomach Relief 262 mg 70677-1080-01 Strategic 6 tablets $0.082 — Availability likely —
Stomach Relief 262 mg 83324-0130-30 Chain 30 tablets $0.082 — Availability likely —
Stomach Relief 262 mg 70000-0591-01 CARDINAL 6 tablets $0.083 — Availability likely —
GNP Pink Bismuth 262 mg 24385-0017-58 Amerisource 40 tablets $0.093 — Availability likely —
Bismuth Subsalicylate 262 mg 70000-0594-01 LEADER/ 24 tablets $0.093 — Availability likely —
Stomach Relief 262 mg 83324-0060-40 Chain 40 tablets $0.093 — Availability likely —
Foster and Thrive Stomach Relief 262 mg 70677-1082-01 Strategic 40 tablets $0.093 — Availability likely —
Walgreen Stomach Relief 262 mg 00363-1423-30 WALGREENS 6 tablets — — FDA listed —
Walgreen 262 mg 00363-9124-30 WALGREEN 30 tablets — — FDA listed —
Walgreens Bismuth Stomach Relief 262 mg 00363-9954-24 Walgreens 24 tablets — — FDA listed —
5 Symptom Digestive Relief 262 mg 11673-0723-48 TARGET 6 tablets — — FDA listed —
Rite Aid Stomach Relief Original Flavor 262 mg 11822-2430-00 RITE 6 tablets — — FDA listed —
Rite Aid Stomach Relief 262 mg 11822-4320-00 RITE 6 tablets — — FDA listed —
Pepto Relief 262 mg 17714-0045-30 Advance 30 tablets — — FDA listed —
Stomach Relief 262 mg 21130-0241-30 SAFEWAY 6 tablets — — FDA listed —
Kroger Stomach Relief 262 mg 30142-0324-30 KROGER 30 tablets — — FDA listed —
Pepto Bismol Chews 262 mg 37000-0996-24 The 24 tablets — — FDA listed —
HEB Stomach Relief Cherry 262 mg 37808-0587-77 H 6 tablets — — FDA listed —
HEB Stomach Relief 262 mg 37808-0937-77 H 6 tablets — — FDA listed —
Equaline Stomach Relief 262 mg 41163-0058-49 UNITED 6 tablets — — FDA listed —
meijer stomach relief 262 mg 41250-0878-30 Meijer 30 tablets — — FDA listed —
Chewable Stomach Relief 262 mg 41415-0124-30 PUBLIX 6 tablets — — FDA listed —
Bismuth Subsalicylate Pink Bismuth 262 mg 42507-0267-77 Hyvee 6 tablets — — FDA listed —
First Aid Direct Peptum Tabs 262 mg 42961-0109-02 Cintas 1 tablet — — FDA listed —
Medique Diotame 262 mg 47682-0210-13 Unifirst 2 tablets — — FDA listed —
Medi-First Pep-T-Med 262 mg 47682-0406-20 Unifirst 6 tablets — — FDA listed —
Pepto Bismol Chewable 5 Symptoms Relief 262 mg 50269-0555-01 JC 2 tablets — — FDA listed —
Goodsense Regular strength Stomach Relief 122 262 mg 50804-0152-49 Good 30 tablets — — FDA listed —
Stomach Relief 262 mg 51013-0321-54 PuraCap 2 tablets — — FDA listed —
CVS Stomach Relief 262 mg 51316-0124-48 CVS 48 tablets — — FDA listed —
Guardian Pink Bismuth 262 mg 53041-0021-41 Guardian 6 tablets — — FDA listed —
Guardian Pink-Bismuth Cherry 262 mg 53041-0022-49 Guardian 6 tablets — — FDA listed —
Pep Tum 262 mg 53117-0046-85 First 1 tablet — — FDA listed —
Pink Bismuth 262 mg 53943-0122-35 Discount 6 tablets — — FDA listed —
Pepto Relief 262 mg 54738-0102-30 Richmond 30 tablets — — FDA listed —
Stomach Relief 262 mg 55301-0124-30 YOUR 30 tablets — — FDA listed —
Family wellness Stomach Relief 262 mg 55319-0122-49 Family 6 tablets — — FDA listed —
Kaopectate 262 mg 55505-0206-69 Kramer 24 tablets — — FDA listed —
Regular Strength Stomach Relief 262 mg 55910-0204-30 DOLGENCORP, 6 tablets — — FDA listed —
Pepto Bismol CHEWABLES 262 mg 58933-0002-12 Procter 2 tablets — — FDA listed —
Pepto Bismol CHEWABLES 262 mg 58933-0011-02 Procter 2 tablets — — FDA listed —
Pepto Bismol CHEWABLES 525 mg/21 58933-0013-02 Procter 2 tablets — — FDA listed —
Stomach Relief 262 mg 63868-0622-30 CDMA- 30 tablets — — FDA listed —
Pepto-Bismol Chewable, TRAVEL BASIX 262 mg 66715-6423-02 Lil' 2 tablets — — FDA listed —
Pepto-Bismol Chewable, CVP HEALTH 262 mg 66715-6523-02 Lil' 2 tablets — — FDA listed —
Stomach Relief, 24-7 Life by 7-Eleven 262 mg 66715-8153-03 Lil' 2 tablets — — FDA listed —
Pepto-Bismol 262 mg 66715-9723-02 Lil' 2 tablets — — FDA listed —
WinCo FOODS Stomach Relief 262 mg 67091-0364-30 WINCO 6 tablets — — FDA listed —
Pepto Bismol 262 mg 67751-0155-01 Navajo 2 tablets — — FDA listed —
Premier Value 262 mg 68016-0124-30 CHAIN 30 tablets — — FDA listed —
Goodsense Regular strength Stomach Relief 122 262 mg 68788-4002-03 Preferred 30 tablets — — FDA listed —
Bismuth Subsalicylate 262 mg 68788-4116-03 Preferred 30 tablets — — FDA listed —
Major Bismuth Subsalicylate 262 mg 68788-8239-03 Preferred 6 tablets — — FDA listed —
Bismuth Chewable 262 mg 68998-0046-88 Marc 1 tablet — — FDA listed —
Bismuth 262 mgthis 69168-0046-69 Allegiant 12 tablets — — FDA listed —
Gastrobiz 262 mg 69168-0999-98 Allegiant 1 tablet — — FDA listed —
Pepto Bismol Fast Melts Fresh Berry Flavored 262 mg 69423-0831-24 The 24 tablets — — FDA listed —
Pepto Bismol Fast Melts Winter Frost Flavored 262 mg 69423-0832-24 The 24 tablets — — FDA listed —
Pepto Bismol Chews 262 mg 69423-0963-24 The 24 tablets — — FDA listed —
Bismuth Subsalicylate 262 mg 69618-0029-03 Reliable 30 tablets — — FDA listed —
CVS Health Stomach relief Cherry Flavor 262 mg 69842-0221-12 CVS 12 tablets — — FDA listed —
Stomach Relief 262 mg 69842-0394-54 CVS 2 tablets — — FDA listed —
Careone Stomach Relief 262 mg 72476-0173-72 Retail 5 tablets — — FDA listed —
Thompson Chewable Bismuth Tabs 262 mg 73408-0407-20 Thompson 6 tablets — — FDA listed —
Pept-Ache 262 mg 73598-1232-01 JHK 1 tablet — — FDA listed —
Topcare Stomach Relief Original Strength 262 mg 76162-0001-85 TopCo 30 tablets — — FDA listed —
TopCare Bismuth Stomach Relief 262 mg 76162-0406-24 TopCo 24 tablets — — FDA listed —
Meijer Bismuth Stomach Relief 262 mg 79481-0097-01 Meijer 24 tablets — — FDA listed —
Equate Stomach Relief 262 mg 79903-0089-49 Wal-Mart 6 tablets — — FDA listed —
Equate Bismuth Stomach Relief Chew 262 mg 79903-0219-24 Walmart 24 tablets — — FDA listed —
Wonderbelly Multi-Symptom 262 mg 82431-0301-04 Ginger 4 tablets — — Discontinued —
Wonderbelly Multi-Symptom 262 mg 82431-0302-04 Ginger 4 tablets — — Discontinued —
Wonderbelly Multi-Symptom 262 mg 82431-0304-04 Ginger 4 tablets — — Discontinued —
Wonderbelly Multi-Symptom 82431-0391-12 Ginger 12 tablets — — Discontinued —
Pepto Bismol 262 mg 84126-0321-70 The 70 tablets — — FDA listed —
Stomach Relief 262 mg 85828-0727-30 Grocery 6 tablets — — FDA listed —
Stomach relief 262 mg 69842-0172-12 CVS 24 tablets — — FDA listed —
up and up 5-symptom digestive relief 262 mg 11673-0125-20 Target 40 tablets — — FDA listed —
meijer stomach relief 262 mg 41250-0324-40 Meijer 40 tablets — — FDA listed —
Kaopectate 262 mg 55505-0197-07 Kramer 28 tablets — — FDA listed —
Topco Stomach Relief 262 mg 36800-0104-28 Topco 40 tablets — — FDA listed —
Equaline Stomach Relief 262 mg 41163-0123-28 UNITED 40 tablets — — FDA listed —
AMAZON Digestive Relief 262 mg 72288-0125-40 AMAZON.COM 40 tablets — — FDA listed —
up and up 5-symptom digestive relief 262 mg 11673-0122-48 Target 48 tablets — — FDA listed —
Digestive Relief 262 mg 21130-0125-40 SAFEWAY 40 tablets — — FDA listed —
Stomach Relief 262 mg 63868-0691-40 CHAIN 40 tablets — — Discontinued —
Walgreen 262 mg 00363-9125-40 WALGREEN 40 tablets — — FDA listed —
Bismuth Subsalicylate 262 mg 69842-0346-12 CVS 24 tablets — — FDA listed —
Rite Aid Digestive Relief 262 mg 11822-1254-00 RITE 40 tablets — — FDA listed —
Stomach Relief 262 mg 49035-0346-10 Wal-Mart 40 tablets — — FDA listed —
Anti-Diarrheal 262 mg 66715-6841-04 Lil' 24 tablets — — FDA listed —
Stomach reliever 262 mg 42507-0707-28 Hyvee 40 tablets — — FDA listed —
Pepto-Bismol 262 mg 58933-0476-01 Procter 2 tablets — — FDA listed —
Pepto-Bismol 262 mg 76420-0490-24 ASCLEMED 24 tablets — — FDA listed —
5-Symptom Digestive Relief 262 mg 11673-0880-44 TARGET 40 tablets — — FDA listed —
Kroger Digestive Relief 262 mg 30142-0524-24 KROGER 24 tablets — — FDA listed —
Stomach Relief 262 mg 37808-0346-08 H 24 tablets — — FDA listed —
POCKET PEPTO Pepto Bismol 262 mg 58933-0017-12 Procter 12 tablets — — FDA listed —
QC Pink Bismuth 262 mg 63868-0171-40 QUALITY 40 tablets — — FDA listed —
Stomach Relief 262 mg 41226-0475-42 Kroger 24 tablets — — FDA listed —
Stomach Relief 262 mg 37835-0207-48 Bi-Mart 48 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

🏛️
2014
On the market since
Dec 2014
📍
2026
Currently FDA-listed
12 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.

What it looks like

Color pink
ShapeRound
ImprintRH046
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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerAllegiant Health
FDA applicationM008 (OTC MONOGRAPH DRUG)
Labeler code69168
First marketedDec 2014
Product typeHuman Otc Drug
Portfolio113 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.

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 📄 Package Label / Principal Display Panel
🎯 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 87 words ▾

Directions chew or dissolve in mouth Adults and children over 12 years : 2 tablets (1 dose) every ½ hour or 4 tablets (2 doses) every hour as needed for diarrhea 2 tablets (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) do not exceed 8 doses (16 tablets) in 24 hours use until diarrhea stops but no more than 2 days Children under 12 years of age: ask a doctor drink plenty of clear fluids to prevent dehydration caused by diarrhea

⚠️ Warnings 180 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 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 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 n diarrhea lasts more than 2 days When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur If pregnant or breast-feeding ask a health professional before use.

🧪 Active Ingredient 12 words ▾

Active ingredient Bismuth subsalicylate 262 mg (each tablet contains 102 mg salicylate)

🧪 Inactive Ingredients 22 words ▾

Inactive Ingredients acacia gum, aspartame, calcium carbonate, D&C red #27 aluminum lake, dextrates, magnesium stearate, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide

🎯 Purpose 2 words ▾

Purpose Antidiarrheal/Antacid

📄 Do Not Use 15 words ▾

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

📄 Ask a Doctor Before Use If 13 words ▾

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

📄 Ask a Doctor or Pharmacist Before Use If 21 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 32 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 n diarrhea lasts more than 2 days

🤰 If Pregnant or Breast-Feeding 10 words ▾

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

📄 Keep Out of Reach of Children 21 words ▾

Keep Out of Reach of Children In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.

📄 Package Label / Principal Display Panel 6 words ▾

Package/Label Principal Display Panel Bismuth Bismuth

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

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

Chronic Kidney Disease1,418
Acute Kidney Injury822
Diarrhoea756
Renal Failure725
Nausea654
End Stage Renal Disease467
Vomiting434

Age at onset

Child6
Adolescent5
Adult367
Elderly368

Reporter sex

5,773 reports
Male · 38%
Female · 62%
Unknown · 0%

Serious outcomes

Hospitalization1,547
Death557
Disabling381
Life-threatening182
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,033 205
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.

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 Allegiant Health. 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 4 other package presentations of this same product, including 30 tablets (69168-0046-88), 50 tablets (69168-0046-50), 100 tablets (69168-0046-32). 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?
Allegiant Health 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.
← 69168-0036-54 · Allegiant 69168-0048-01 · Allegiant →
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.