Kaopectate Bismuth subsalicylate 262 mg Tablet, Coated
by Kramer Laboratories · 2 CARTON in 1 PACKAGE (55505-197-78) / 1 BOTTLE in 1 CARTON / 42 TABLET, COATED in 1 BOTTLE
NDC 55505-0197-78
🏷️ FDA NDC (as labeled)
55505-197-78
billing pads the product segment with a zero
This package
Contains42 tablet, coated in 1 bottle
Pack sizes4 compare ↓
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)
55505-197-78
Product NDC
55505-197
11-digit billing NDC
55505019778
UNII
62TEY51RR1
UPC
0053076000405
Application #
M008
SPL Set ID
3877a88d-9546-48ce-ad6b-3c2a115e3eaf
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
2020-10-01
Route
ORAL
Dosage form
TABLET, COATED
Substance
BISMUTH SUBSALICYLATE
Why two NDCs?
The FDA registers this code as 55505-197-78 — 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 → 55505-0197-78. 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
LabelerKramer Laboratories
FDA applicationM008 (OTC MONOGRAPH DRUG)
Labeler code55505
First marketedOct 2020
Product typeHuman Otc Drug
Portfolio26 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
📗 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
ImprintK
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 Y6O7T4G8P9
Hydrated silica is a fine powder form of silicon dioxide with absorbed water. It works as an anti-caking agent and absorbent in medicines, helping powders stay free-flowing and preventing clumping.
-
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 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 T5L8T28FGP
Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
-
UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
-
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, hydrated silica, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, 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 each | Per 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.
🔁 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 mg 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 mgthis 55505-0197-78 | Kramer | 42 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
🏛️
2020
On the market since
Oct 2020
📍
2026
Currently FDA-listed
6 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 Kaopectate (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 45%
Female · 55%
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 |
|---|---|---|---|
| 55505-0197-07 | 1 BOTTLE in 1 CARTON (55505-197-07) / 28 TABLET, COATED in 1 BOTTLE | 2020-10-01 | Active |
| 55505-0197-70 | 1 BOTTLE in 1 CARTON (55505-197-70) / 42 TABLET, COATED in 1 BOTTLE | 2021-02-01 | Active |
| 55505-0197-77 | 1 BOTTLE in 1 CARTON (55505-197-77) / 84 TABLET, COATED in 1 BOTTLE | 2025-11-15 | Active |
| 55505-0197-78 You're viewing this | 2 CARTON in 1 PACKAGE (55505-197-78) / 1 BOTTLE in 1 CARTON / 42 TABLET, COATED in 1 BOTTLE | 2025-04-23 | Active |
Pack size FAQ
What quantity is in NDC 55505-0197-78?
NDC 55505-0197-78 is listed by the FDA — 2 carton in 1 package / 1 bottle in 1 carton / 42 tablet, coated in 1 bottle.
What NDC number is used to bill for this package of Kaopectate Bismuth subsalicylate 262 mg Tablet, Coated?
Bill NDC 55505-0197-78 — the 11-digit billing format is 55505019778. 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 55505-197-78, 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: 55505-0197-78, written without dashes as 55505019778. 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 55505-0197-78, the first segment (55505) is the labeler code FDA assigned to Kramer Laboratories; the middle segment (0197) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (78) 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 Kramer Laboratories. 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 3 other package presentations of this same product, including 28 tablets (55505-0197-07), 42 tablets (55505-0197-70), 84 tablets (55505-0197-77). 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?
Kramer Laboratories 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
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses relieves: traveler’s diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas belching fullness
⏱️ Dosage and Administration ▾
Directions adults and children 12 years of age and older: 2 caplets (1 dose) swallow caplets with water; do not chew repeat dose every 1/2 hour to 1 hour as needed do not exceed 8 doses 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 ▾
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 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 right away.
🧪 Active Ingredient ▾
Active ingredient (per caplet) Purposes Bismuth subsalicylate 262 mg Anti-diarrheal, Upset stomach reliever
🧪 Inactive Ingredients ▾
Inactive ingredients croscarmellose sodium, crospovidone, hydrated silica, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin
🎯 Purpose ▾
Active ingredient (per caplet) Purposes Bismuth subsalicylate 262 mg Anti-diarrheal, Upset stomach reliever
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.