Home › NDC Lookup › Ingredients › Bismuth Subsalicylate › 53041-0022-49
⚪image loading
(from DailyMed)

Guardian Pink-Bismuth Cherry Bismuth subsalicylate 262 mg Tablet, Chewable

by Guardian Drug Company · 5 BLISTER PACK in 1 BOX (53041-022-49) / 6 TABLET, CHEWABLE in 1 BLISTER PACK
NDC 53041-0022-49
🏷️ FDA NDC (as labeled) 53041-022-49 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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) 53041-022-49
Product NDC 53041-022
11-digit billing NDC 53041002249
RxCUI 308761
UNII 62TEY51RR1
Application # part335
SPL Set ID fe632563-c3de-4214-b41d-4e7a1fbfcf59
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 2023-12-04
Route ORAL
Dosage form TABLET, CHEWABLE
Substance BISMUTH SUBSALICYLATE
Why two NDCs? The FDA registers this code as 53041-022-49 — 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 → 53041-0022-49. 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

LabelerGuardian Drug Company
FDA applicationpart335 (OTC MONOGRAPH DRUG)
Labeler code53041
First marketedDec 2023
Product typeHuman Otc Drug
Portfolio46 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
ShapeRound
ImprintGDC122
Size16 mm
ScoringNot scored
FlavorCherry
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.

💲 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.
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
Major Bismuth Subsalicylate 262 mg 00904-7205-46 Major 6 tablets $0.083 — Availability likely —
GNP Pink Bismuth 262 mg 46122-0701-65 Amerisource 6 tablets $0.083 — Availability likely —
McKesson Bismuth 262 mg 68599-4744-07 McKesson 2 tablets $0.083 — Availability likely —
Foster and Thrive Stomach Relief 262 mg 70677-1080-01 Strategic 6 tablets $0.083 — Availability likely —
Stomach Relief 262 mg 83324-0130-30 Chain 30 tablets $0.083 — Availability likely —
Stomach Relief 262 mg 70000-0591-01 CARDINAL 6 tablets $0.083 — 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 mgthis 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 mg 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 —
Pepto Bismol CHEWABLES 262 mg 85237-1903-01 Select 2 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

🏛️
2023
On the market since
Dec 2023
📍
2026
Currently FDA-listed
3 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 Guardian Pink-Bismuth Cherry (this brand).

Top reported reactions

Nausea93
Vomiting76
Diarrhoea70
Abdominal Pain60
Pain53
Constipation48
Abdominal Distension43

Age at onset

Adolescent2
Adult39
Elderly48

Reporter sex

604 reports
Male · 44%
Female · 56%

Serious outcomes

Death125
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 50 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
53041-0022-49 You're viewing this 5 BLISTER PACK in 1 BOX (53041-022-49) / 6 TABLET, CHEWABLE in 1 BLISTER PACK 2023-12-04 Active

🧭 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 — Not published for this NDC No photo available yet for this listing.
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 FDA registers it as 53041-022-49, 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: 53041-0022-49, written without dashes as 53041002249. 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 53041-0022-49, the first segment (53041) is the labeler code FDA assigned to Guardian Drug Company; the middle segment (0022) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (49) 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 Guardian Drug Company. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Guardian Drug Company 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 12 words ▾

USE(S) relieves: diarrhea heartburn indigestion nausea upset stomach associated with these symptoms

⏱️ Dosage and Administration 52 words ▾

DIRECTIONS chew or dissolve in mouth adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed do not take more than 8 doses (16 tablets) in 24 hours children under 12 years: ask a doctor drink plenty of fluids to help prevent dehydration caused by diarrhea

⚠️ Warnings 73 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 behaviour 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

📦 Storage and Handling 39 words ▾

OTHER INFORMATION each tablet contains: sodium less than 1 mg salicylate 102 mg very low sodium avoid excessive heat (over 104 o F or 40 o C) TAMPER EVIDENT: Do not use if individual compartments are torn or open

🧪 Active Ingredient 14 words ▾

ACTIVE INGREDIENT(in each tablet) Bismuth subsalicylate 262 mg (total salicylate 102 mg per tablet)

🧪 Inactive Ingredients 25 words ▾

INACTIVE INGREDIENTS adipic acid, calcium carbonate, D&C red 27 aluminum lake, FD&C red 40 aluminum lake, flavors, magnesium stearate, mannitol, povidone, pregelatinized starch, saccharin sodium

🎯 Purpose 6 words ▾

PURPOSE Upset stomach reliever and anti-diarrheal

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 53041-0021-41 · Guardian 53041-0098-17 · Guardian →
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.