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Kaopectate Vanilla Flavor Anti Diarrheal bismuth subsalicylate 262 mg/15mL Liquid, 325 mL — NDC 55505-0198-64 package photo

Kaopectate Vanilla Flavor Anti Diarrheal bismuth subsalicylate 262 mg/15mL Liquid, 325 mL

by Kramer Laboratories · 325 mL in 1 BOTTLE (55505-198-64)
NDC 55505-0198-64
🏷️ FDA NDC (as labeled) 55505-198-64 billing pads the product segment with a zero
This package
Contains325 mL Pack sizes3 compare ↓
Also comes in: 2 bottles 55505-0198-82 236 ml 55505-0198-36
OTC On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 55505-198-64
Product NDC 55505-198
11-digit billing NDC 55505019864
NCPDP billing unit ML — per mL (volume)
RxCUI 308762, 642346
UNII 62TEY51RR1
UPC 0053076198645
Application # M008
SPL Set ID 3ad310c8-3dfa-4435-87bf-17f1c0a9ca45
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 LIQUID
Substance BISMUTH SUBSALICYLATE
Why two NDCs? The FDA registers this code as 55505-198-64 — 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 → 55505-0198-64. 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

📖 What it is MedlinePlus · NLM

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

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's used to relieve diarrhea — including traveler's diarrhea — and upset stomach symptoms that come from overdoing it on food or drink. That includes heartburn, indigestion, nause...
  • What exactly is bismuth subsalicylate used for?
  • A dark or black stool — and sometimes a darkened tongue — is a well-known, harmless side effect of bismuth subsalicylate. It's just the way the medicine reacts in your digestive tr...
  • Why did my stool turn black after taking this? Should I be worried?
📖 Read our full Bismuth Subsalicylate guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

FlavorVanilla
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 K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • 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 WIQ1H85SYP
    A salt form of salicylic acid, sodium salicylate is a chemical compound used in medicines as a buffer or pH regulator. It helps maintain the medicine's stability and proper acidity level during storage and use.
  • UNII X045WJ989B
    Sorbic acid is a preservative derived from berries that prevents mold, yeast, and bacterial growth in medicines. It keeps the product stable and safe during storage.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • 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.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statescarboxymethylcellulose sodium, flavor, microcrystalline cellulose, purified water, sodium salicylate, sorbic acid, sucrose, xanthan gum

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

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

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer 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.
Try another pack size: 2 bottles 236 ml
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Stomach Relief Regular Strength 525 mg/30mL 62011-0435-01 Strategic 237 ml $0.011 — FDA listed —
Stomach Relief Regular Strength 525 mg/30mL 70677-0094-01 Strategic 237 ml $0.011 — FDA listed —
Stomach Relief Regular Strength 525 mg/30mL 00536-1286-36 Rugby 237 ml $0.012 — Availability likely —
Stomach Relief Regular Strength 525 mg/30mL 70000-0698-01 CARDINAL 236 ml $0.013 — Availability likely —
Foster and Thrive Regular Strength Stomach Relief 527 525 mg/30mL 70677-1191-01 Strategic 236 ml $0.013 — Availability likely —
Quality Choice Regular Strength Stomach Relief 525 mg/30mL 83324-0020-08 Chain 236 ml $0.013 — Availability likely —
QCH Stomach Relief 535 525 mg/30mL 83324-0022-08 Chain 236 ml $0.013 — Availability likely —
GNP Stomach Relief 525 mg/30mL 46122-0703-26 Amerisource 118 ml $0.017 — Availability likely —
Stomach Relief Original Strength 525 mg/30mL 70000-0044-01 Cardinal 118 ml $0.017 — Availability likely —
Soothe 525 mg/30mL 00363-0073-08 Walgreens 237 ml — — FDA listed —
Soothe 525 mg/30mL 00363-0736-16 Walgreens 473 ml — — FDA listed —
Stomach Relief 525 mg/30mL 00363-7024-16 Walgreens 473 ml — — FDA listed —
Soothe 525 mg/30mL 00363-7240-08 Walgreens 237 ml — — FDA listed —
5-Symptom Digestive Relief 525 mg/30mL 11673-0291-06 TARGET 236 ml — — FDA listed —
Digestive Relief Regular Strength 525 mg/30mL 11673-0372-08 TARGET 236 ml — — FDA listed —
up and up digestive relief 525 mg/30mL 11673-0706-08 Target 236 ml — — FDA listed —
Digestive Relief Regular Strength 525 mg/30mL 11673-0724-16 TARGET 473 ml — — FDA listed —
Stomach Relief Regular Strength 525 mg/30mL 11822-2910-07 Rite 473 ml — — FDA listed —
Rite Aid Regular Strngth Pink Bismuth 525 mg/30mL 11822-7016-06 RITE 473 ml — — FDA listed —
RITE AID Regular Strength Pink Bismuth 525 mg/30mL 11822-7060-03 RITE 2 bottles — — FDA listed —
Stomach Relief Regular Strength 525 mg/30mL 17856-1286-01 ATLANTIC 50 cups — — FDA listed —
Stomach Relief Regular Strength 525 mg/30mL 17856-8286-01 Atlantic 50 cups — — FDA listed —
SIGNATURE CARE Regular Strength 525 mg/30mL 21130-0182-12 SAFEWAY 354 ml — — FDA listed —
Stomach Relief Regular Strength 525 mg/30mL 21130-0624-08 Safeway, 237 ml — — FDA listed —
Kroger Regular Strength Pink Bismuth 525 mg/30mL 30142-0608-08 KROGER 236 ml — — FDA listed —
Stomach Relief Regular Strength 525 mg/30mL 30142-0624-08 The 237 ml — — FDA listed —
Stomach Relief Regular Strength 525 mg/30mL 30142-0680-01 The 2 bottles — — FDA listed —
TopCare Stomach Relief Regular Strength 525 mg/30mL 36800-0338-08 TOPCO 236 ml — — FDA listed —
TopCare Regular Strength 525 mg/30mL 36800-0661-08 TOPCO 236 ml — — FDA listed —
Topcare Stomach Relief cherry 525 mg/30mL 36800-0769-04 Topco 236 ml — — FDA listed —
Pepto-Bismol 525 mg/30mL 37000-0438-04 The 118 ml — — FDA listed —
Pepto-Bismol Cherry 525 mg/30mL 37000-0439-08 The 236 ml — — FDA listed —
HEB Stomach Relief Regular Strength 525 mg/30mL 37808-0607-08 H 236 ml — — FDA listed —
Equaline Stomach Relief 525 mg/30mL 41163-0535-04 UNITED 236 ml — — FDA listed —
Equaline Stomach Relief 525 mg/30mL 41163-0936-04 UNITED 237 ml — — FDA listed —
meijer stomach relief regular strength 525 mg/30mL 41250-0670-12 MEIJER 354 ml — — FDA listed —
meijer stomach relief regular strength 525 mg/30mL 41250-0671-16 MEIJER 473 ml — — FDA listed —
PUBLIX Regular Strength Pink Bismuth 525 mg/30mL 41415-0706-08 PUBLIX 236 ml — — FDA listed —
Stomach Relief Regular Strength 525 mg/30mL 49035-0725-08 EQUATE 237 ml — — FDA listed —
Stomach Relief Regular Strength 525 mg/30mL 49580-0624-06 P 473 ml — — FDA listed —
Stomach Relief Regular Strength 525 mg/30mL 49580-0724-01 P 473 ml — — FDA listed —
Stomach Relief Regular Strength 525 mg/30mL 49580-0736-08 P 237 ml — — Discontinued —
GS Stomach Relief 525 mg/30mL 50804-0122-04 Good 236 ml — — FDA listed —
Pink-Bismuth 262 mg/15mL 53041-0527-03 Guardian 118 ml — — FDA listed —
Bismutina 525 mg/30mL 53145-0475-08 Menper 240 ml — — FDA listed —
Stomach Relief Regular Strength 525 mg/30mL 53942-0557-28 Demoulas 354 ml — — FDA listed —
Pink Bismuth Original 525 mg/30mL 53943-0529-06 Discount 473 ml — — FDA listed —
Pink Bismuth Regular Strength 525 mg/30mL 53943-0535-06 Discount 473 ml — — FDA listed —
Stomach Relief 525 mg/30mL 55319-0560-08 Family 237 ml — — FDA listed —
Stomach Relief 525 mg/30mL 55319-0951-08 Family 237 ml — — FDA listed —
Kaopectate Vanilla Flavor Anti Diarrheal 262 mg/15mLthis 55505-0198-64 Kramer 325 ml — — FDA listed —
Kaopectate Peppermint Flavor Anti Diarrheal 262 mg/15mL 55505-0199-36 Kramer 236 ml — — FDA listed —
Rapidol Stomach Relief 525 mg/30mL 55758-0331-08 Pharmadel 240 ml — — Discontinued —
Stomach Relief Regular Strength 525 mg/30mL 55910-0436-08 Dolgencorp, 237 ml — — FDA listed —
Stomach Relief Regular Strength 525 mg/30mL 55910-0624-04 Dolgencorp, 118 ml — — FDA listed —
Stomach Relief 525 mg/30mL 57243-0557-26 Consumer 237 ml — — FDA listed —
CVS Health Anti-Diarrheal Vanilla 262 mg/15mL 59779-0883-12 CVS 355 ml — — FDA listed —
QC Stomach Relief Cherry Flavor 525 mg/30mL 63868-0305-08 QUALITY 236 ml — — FDA listed —
QC Anti Diarrheal Vanilla Regular Flavor 262 mg/15mL 63868-0339-12 QUALITY 355 ml — — FDA listed —
Stomach Relief Regular Strength 525 mg/30mL 63868-0907-08 QUALITY 237 ml — — Discontinued —
Stomach Relief Regular Strength 525 mg/30mL 63941-0724-04 Best 118 ml — — FDA listed —
Stomach Circle K 525 mg/30mL 66715-5555-04 Lil' 237 ml — — FDA listed —
Stomach Lil Drug Store Products 525 mg/30mL 66715-6855-04 Lil' 237 ml — — FDA listed —
Stomach Relief, Caseys 4good 525 mg/30mL 66715-8355-04 Lil' 237 ml — — FDA listed —
Stomach Relief, 24-7 Life 525 mg/30mL 66715-8554-02 Lil' 237 ml — — FDA listed —
WinCo FOODS Stomach Relief 525 mg/30mL 67091-0362-23 WINCO 236 ml — — FDA listed —
Premier Value Diarrhea Relief Vanilla Flavor 262 mg/15mL 68016-0317-12 PHARMACY 355 ml — — FDA listed —
Regular Strength Pink Bismuth 525 mg/30mL 68163-0706-04 Raritan 118 ml — — FDA listed —
Stomach Relief 525 mg/30mL 69256-0527-04 Harris 236 ml — — FDA listed —
Stomach Relief regular strength 525 mg/30mL 69842-0227-04 CVS 118 ml — — FDA listed —
Maximum strength Stomach Relief 525 mg/30mL 69842-0528-04 CVS 236 ml — — FDA listed —
regular strength pink bismuth 525 mg/30mL 69842-0766-12 CVS 354 ml — — FDA listed —
AMAZON Regular Strength 525 mg/30mL 72288-0706-16 AMAZON.COM 473 ml — — FDA listed —
Regular Strength Stomach Relief 525 mg/30mL 72476-0527-06 Retail 473 ml — — FDA listed —
Stomach Relief Regular Strength 525 mg/30mL 72476-0724-08 Care 237 ml — — FDA listed —
Stomach Relief Regular Strength 525 mg/30mL 72476-0736-08 Care 237 ml — — FDA listed —
Stomach Relief - Regular Strength 525 mg/30mL 76281-0537-25 AptaPharma 177 ml — — FDA listed —
Bismuth Subsalicylate Suspension Regular Strength 525 mg/30mL 76281-0557-28 AptaPharma 354 ml — — FDA listed —
Stomach Relief 525 mg/30mL 79903-0311-16 WALMART 473 ml — — FDA listed —
Dye Free Regular Strength Stomach Relief 525 mg/30mL 79903-0427-16 Walmart 473 ml — — FDA listed —
Bismuth Subsalicylate Suspension Regular Strength 525 mg/30mL 81522-0557-28 FSA 354 ml — — FDA listed —
Stomach Relief Regular Strength 525 mg/30mL 82501-7240-08 Gobrands, 237 ml — — FDA listed —
Revasol Peptic Relief 525 mg/30mL 84379-0283-04 Rnv 118 ml — — FDA listed —
Dr. Simi Stomach Relief 525 mg/30mL 85786-0802-12 Farmacias 354 ml — — FDA listed —
Stomach Relief 525 mg/30mL 85828-0791-07 Grocery 473 ml — — 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 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
Life-threatening182
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,033 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
55505-0198-36 236 mL in 1 BOTTLE (55505-198-36) 2020-10-01 Active
55505-0198-64 You're viewing this 325 mL in 1 BOTTLE (55505-198-64) 2022-02-01 Active
55505-0198-82 2 BOTTLE in 1 PACKAGE (55505-198-82) / 325 mL in 1 BOTTLE 2025-06-01 Active

Pack size FAQ

What quantity is in NDC 55505-0198-64?
NDC 55505-0198-64 contains 325 mL — 325 ml in 1 bottle.
What is the difference between NDC 55505-0198-64 and NDC 55505-0198-36?
Both are Kaopectate Vanilla Flavor Anti Diarrheal bismuth subsalicylate 262 mg/15mL Liquid — the drug itself is identical. NDC 55505-0198-64 is the 325 mL package, while NDC 55505-0198-36 is the 236 ml package.
What NDC number is used to bill for this package of Kaopectate Vanilla Flavor Anti Diarrheal bismuth subsalicylate 262 mg/15mL Liquid?
Bill NDC 55505-0198-64 — the 11-digit billing format is 55505019864. 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 55505-198-64, 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: 55505-0198-64, written without dashes as 55505019864. 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 55505-0198-64, the first segment (55505) is the labeler code FDA assigned to Kramer Laboratories; the middle segment (0198) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (64) 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 2 other package presentations of this same product, including 2 bottles (55505-0198-82), 236 ml (55505-0198-36). 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 21 words ▾

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 72 words ▾

Directions shake well immediately before each use only use pre-measured dose cup adults and children 12 years of age and older: 1 dose (30 mL) every 1/2 hour to 1 hour as needed. do not exceed 8 doses (240 mL) 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 197 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 a sodium-restricted diet fever mucus in the stool Ask a doctor or pharmacist before use if you are taking any drug for diabetes gout arthritis anticoagulation (thinning the blood) 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 14 words ▾

Active ingredient (per 15 mL) Purposes Bismuth subsalicylate 262 mg Anti-diarrheal Upset stomach reliever

🧪 Inactive Ingredients 17 words ▾

Inactive I ngredients carboxymethylcellulose sodium, flavor, microcrystalline cellulose, purified water, sodium salicylate, sorbic acid, sucrose, xanthan gum

🎯 Purpose 14 words ▾

Active ingredient (per 15 mL) Purposes Bismuth subsalicylate 262 mg Anti-diarrheal Upset stomach reliever

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 55505-0197-07 · Kramer 55505-0199-36 · Kramer →
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.