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Rapidol Stomach Relief BISMUTH SUBSALICYLATE 525 mg/30mL Liquid, 240 mL — NDC 55758-0331-08 package photo

Rapidol Stomach Relief BISMUTH SUBSALICYLATE 525 mg/30mL Liquid, 240 mL

by Pharmadel LLC · 240 mL in 1 BOTTLE (55758-331-08)
NDC 55758-0331-08
🏷️ FDA NDC (as labeled) 55758-331-08 billing pads the product segment with a zero
This package
Contains240 mL Pack sizes2 compare ↓
Also comes in: 237 ml 55758-0331-07
OTC Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ 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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 55758-331-08
Product NDC 55758-331
11-digit billing NDC 55758033108
RxCUI 308762
UNII 62TEY51RR1
Application # M008
SPL Set ID efba1aea-f468-4f63-e053-2995a90a545b
Established class (EPC) Bismuth
Chemical class Bismuth
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2022-12-08
Route ORAL
Dosage form LIQUID
Substance BISMUTH SUBSALICYLATE
Why two NDCs? The FDA registers this code as 55758-331-08 — 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 → 55758-0331-08. 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

LabelerPharmadel LLC
FDA applicationM008 (OTC MONOGRAPH DRUG)
Labeler code55758
First marketedDec 2022
Product typeHuman Otc Drug
Portfolio67 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 calm a range of stomach and digestive problems — things like diarrhea, traveler's diarrhea, heartburn, indigestion, nausea, gas, belching, and that uncomfortable over-...
  • What is bismuth subsalicylate actually used for?
  • Don't panic — that's actually a very common and completely harmless side effect of bismuth subsalicylate. The medicine can temporarily turn your stool and even your tongue a dark o...
  • 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

Color pink
FlavorMint
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 8SKN0B0MIM
    Benzoic acid is a naturally occurring organic acid used as a preservative in medicines and foods. It helps prevent bacterial and fungal growth to extend shelf life and maintain product stability.
  • UNII 1678RKX8RT
    A synthetic red dye used to color tablets, capsules, and liquid medicines. It helps make pills visually distinct and easier to identify.
  • UNII 767IP0Y5NH
    A synthetic red colorant used to give medicines their color. It helps patients identify their medication and makes the product visually appealing.
  • UNII SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • UNII O414PZ4LPZ
    A beta hydroxy acid derived from willow bark or synthesized chemically. In topical medicines, it acts as a keratolytic agent that helps soften and shed dead skin cells, improving penetration of active ingredients.
  • 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 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.

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

The official label also statesbenzoic acid, D&C red #22, D&C red #28, flavor, purified water, saccharin sodium, salicylic acid, sodium salicylate, 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: 237 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 — Discontinued —
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/15mL 55505-0198-36 Kramer 236 ml — — FDA listed —
Kaopectate Peppermint Flavor Anti Diarrheal 262 mg/15mL 55505-0199-36 Kramer 236 ml — — FDA listed —
Rapidol Stomach Relief 525 mg/30mLthis 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 —
Medique Diotame Instydose 525 mg/30mL 47682-0670-69 Unifirst 180 ml — — FDA listed —
Green Guard Instydose Upset Stomach Relief 525 mg/30mL 47682-0770-69 Unifirst 180 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

🏛️
2022
On the market since
Dec 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
55758-0331-08 You're viewing this 240 mL in 1 BOTTLE (55758-331-08) 2022-12-26 Discontinued by firm
55758-0331-07 237 mL in 1 BOTTLE (55758-331-07) 2023-02-08 Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 55758-0331-08?
NDC 55758-0331-08 contains 240 mL — 240 ml in 1 bottle.
What is the difference between NDC 55758-0331-08 and NDC 55758-0331-07?
Both are Rapidol Stomach Relief BISMUTH SUBSALICYLATE 525 mg/30mL Liquid — the drug itself is identical. NDC 55758-0331-08 is the 240 mL package, while NDC 55758-0331-07 is the 237 ml package.
What NDC number is used to bill for this package of Rapidol Stomach Relief BISMUTH SUBSALICYLATE 525 mg/30mL Liquid?
Bill NDC 55758-0331-08 — the 11-digit billing format is 55758033108. 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 No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 55758-331-08, 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: 55758-0331-08, written without dashes as 55758033108. 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 55758-0331-08, the first segment (55758) is the labeler code FDA assigned to Pharmadel LLC; the middle segment (0331) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (08) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 237 ml (55758-0331-07). 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?
Pharmadel LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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 travelers' diarrhea diarrhea upset stomach due to overindulgence of food and drink including: heart burn indigestion nausea gas belching

⏱️ Dosage and Administration 77 words ▾

Directions s hake well before use use dose cup or tablespoon (TBSP) adults and children 12 years and over: 1 dose (30 mL or 2 TBSP) every 1/2 to 1 hour or every hour as needed do not exceed 8 doses (240 mL or 16 TBSP) in 24 hours use until diarrhea stops but not more than 2 days drink plenty of clear fluids to help prevent dehydration caused by diarrhea children under 12 years: ask adoctor

⚠️ Warnings 201 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 black or bloody stool Ask a doctor before use if you have fever mucus in stool Ask a doctor or pharmacist before use if you are taking any drug for anticoagulation (thinning of the blood) diabetes gout arthritis When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur. Slop use and ask a doctor if diarrhea lasts more than 2 days symptoms get worse or last more than 2 days ringing in the ears or loss of hearing occurs If pregnant or breast feeding, ask 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 25 words ▾

Active ingredient & Purposes Active ingredient (in each 30 mL dose cup or 2 tablespoons) Purposes Bismuth subsalicylate 525 mg................. Upset stomach reliever and antidiarrhea

🧪 Inactive Ingredients 21 words ▾

Inactive ingredients benzoic acid, D&C red #22, D&C red #28, flavor, purified water, saccharin sodium, salicylic acid, sodium salicylate, xanthan gum

🎯 Purpose 21 words ▾

Active ingredient (in each 30 mL dose cup or 2 tablespoons) Purposes Bismuth subsalicylate 525 mg................. Upset stomach reliever and antidiarrhea

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 55758-0326-25 · Pharmadel 55758-0360-03 · Pharmadel →
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.