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Pepto Bismol BISMUTH SUBSALICYLATE 262 mg Tablet, Chewable, 2-count — NDC 67751-0155-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Pepto Bismol BISMUTH SUBSALICYLATE 262 mg Tablet, Chewable, 2-count — NDC 67751-155-01 (Billing 67751-0155-01)

by Navajo Manufacturing Company Inc. · 1 POUCH in 1 CARTON / 2 TABLET, CHEWABLE in 1 POUCH

This is a package of 2 tablets of Pepto Bismol BISMUTH SUBSALICYLATE 262 mg Tablet, Chewable from Navajo Manufacturing Company Inc., marketed since Sep 2016 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 67751-0155-01
🏷️ FDA NDC (as labeled) 67751-155-01 billing pads the product segment with a zero
This package
Contains2-count Pack sizes3 compare ↓
Main listing for product 67751-155 · Also comes in: 2 tablets 67751-155-06 4 tablets 67751-155-02
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 67751-155-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
67751 labeler · 155 product · 01 package
Package marketed since
Sep 20, 2016
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 6775115501 5
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 67751-155-01
Product NDC 67751-155
11-digit billing NDC 67751015501
RxCUI 211151, 308761
UNII 62TEY51RR1
Application # M008
SPL Set ID 033bccc6-6e81-487f-91fe-9d7cc465e1b2
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 2016-09-20
Route ORAL
Dosage form TABLET, CHEWABLE
Substance BISMUTH SUBSALICYLATE
Quick answers
  • RxCUI (RxNorm): 211151
Why two NDCs? The FDA registers this code as 67751-155-01 — 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 → 67751-0155-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Bismuth class.

Pharmacologic class Bismuth
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It relieves diarrhea, including traveler's diarrhea. It also helps with upset stomach after overindulging in food and drink, such as heartburn, indigestion, nausea, gas, belching a...
  • Use it only until the diarrhea stops, and no more than 2 days. If you're not better by then, or you get worse sooner, stop and see a doctor. Drink plenty of clear fluids while you...
  • That's a known, temporary and harmless effect of this medicine. But black stool can also signal bleeding, so do not use it if you already have bloody or black stool.
  • Children under 12 should be checked by a doctor first. Children and teens who have or are recovering from chicken pox or flu-like symptoms should not use it because of Reye's syndr...
📖 Read our full Bismuth Subsalicylate guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

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

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 2 tablets 4 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
67751-0155-01 You're viewing this Main listing 1 POUCH in 1 CARTON / 2 TABLET, CHEWABLE in 1 POUCH 2016-09-20 — Active
67751-0155-02 67751-155-02 1 POUCH in 1 CARTON / 4 TABLET, CHEWABLE in 1 POUCH 2016-09-20 — Active
67751-0155-06 67751-155-06 3 POUCH in 1 CARTON / 2 TABLET, CHEWABLE in 1 POUCH 2025-04-22 — Active

Pack size FAQ

What quantity is in this package?
This is a 2-count package — 1 pouch in 1 carton / 2 tablet, chewable in 1 pouch.
How does this package differ from NDC 67751-0155-02?
Both are Pepto Bismol BISMUTH SUBSALICYLATE 262 mg Tablet, Chewable — the drug itself is identical. This page's package is the 2-count one, while NDC 67751-0155-02 is the 4 tablets package.
What NDC number is used to bill for this package of Pepto Bismol BISMUTH SUBSALICYLATE 262 mg Tablet, Chewable?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Major Bismuth Subsalicylate 262 mg 00904-7205-46 Major 6 tablets $0.082 — Availability likely —
GNP Pink Bismuth 262 mg 46122-0701-65 Amerisource 6 tablets $0.082 — Availability likely —
McKesson Bismuth 262 mg 68599-4744-07 McKesson 2 tablets $0.082 — Availability likely —
Foster and Thrive Stomach Relief 262 mg 70677-1080-01 Strategic 6 tablets $0.082 — Availability likely —
Stomach Relief 262 mg 83324-0130-30 Chain 30 tablets $0.082 — Availability likely —
Stomach Relief 262 mg 70000-0591-01 CARDINAL 6 tablets $0.083 — Availability likely —
Walgreen Stomach Relief 262 mg 00363-1423-30 WALGREENS 6 tablets — — FDA listed —
Walgreen 262 mg 00363-9124-30 WALGREEN 30 tablets — — FDA listed —
Walgreens Bismuth Stomach Relief 262 mg 00363-9954-24 Walgreens 24 tablets — — FDA listed —
5 Symptom Digestive Relief 262 mg 11673-0723-48 TARGET 6 tablets — — FDA listed —
Rite Aid Stomach Relief Original Flavor 262 mg 11822-2430-00 RITE 6 tablets — — FDA listed —
Rite Aid Stomach Relief 262 mg 11822-4320-00 RITE 6 tablets — — FDA listed —
Pepto Relief 262 mg 17714-0045-30 Advance 30 tablets — — FDA listed —
Stomach Relief 262 mg 21130-0241-30 SAFEWAY 6 tablets — — FDA listed —
Kroger Stomach Relief 262 mg 30142-0324-30 KROGER 30 tablets — — FDA listed —
Pepto Bismol Chews 262 mg 37000-0996-24 The 24 tablets — — FDA listed —
HEB Stomach Relief Cherry 262 mg 37808-0587-77 H 6 tablets — — FDA listed —
HEB Stomach Relief 262 mg 37808-0937-77 H 6 tablets — — FDA listed —
Equaline Stomach Relief 262 mg 41163-0058-49 UNITED 6 tablets — — FDA listed —
meijer stomach relief 262 mg 41250-0878-30 Meijer 30 tablets — — FDA listed —
Chewable Stomach Relief 262 mg 41415-0124-30 PUBLIX 6 tablets — — FDA listed —
Bismuth Subsalicylate Pink Bismuth 262 mg 42507-0267-77 Hyvee 6 tablets — — FDA listed —
First Aid Direct Peptum Tabs 262 mg 42961-0109-02 Cintas 1 tablet — — FDA listed —
Medique Diotame 262 mg 47682-0210-13 Unifirst 2 tablets — — FDA listed —
Medi-First Pep-T-Med 262 mg 47682-0406-20 Unifirst 6 tablets — — FDA listed —
Pepto Bismol Chewable 5 Symptoms Relief 262 mg 50269-0555-01 JC 2 tablets — — FDA listed —
Goodsense Regular strength Stomach Relief 122 262 mg 50804-0152-49 Good 30 tablets — — FDA listed —
Stomach Relief 262 mg 51013-0321-54 PuraCap 2 tablets — — FDA listed —
CVS Stomach Relief 262 mg 51316-0124-48 CVS 48 tablets — — FDA listed —
Guardian Pink Bismuth 262 mg 53041-0021-41 Guardian 6 tablets — — FDA listed —
Guardian Pink-Bismuth Cherry 262 mg 53041-0022-49 Guardian 6 tablets — — FDA listed —
Pep Tum 262 mg 53117-0046-85 First 1 tablet — — FDA listed —
Pink Bismuth 262 mg 53943-0122-35 Discount 6 tablets — — FDA listed —
Pepto Relief 262 mg 54738-0102-30 Richmond 30 tablets — — FDA listed —
Stomach Relief 262 mg 55301-0124-30 YOUR 30 tablets — — FDA listed —
Family wellness Stomach Relief 262 mg 55319-0122-49 Family 6 tablets — — FDA listed —
Kaopectate 262 mg 55505-0206-69 Kramer 24 tablets — — FDA listed —
Regular Strength Stomach Relief 262 mg 55910-0204-30 DOLGENCORP, 6 tablets — — FDA listed —
Pepto Bismol CHEWABLES 262 mg 58933-0002-12 Procter 2 tablets — — FDA listed —
Pepto Bismol CHEWABLES 262 mg 58933-0011-02 Procter 2 tablets — — FDA listed —
Pepto Bismol CHEWABLES 525 mg/21 58933-0013-02 Procter 2 tablets — — FDA listed —
Stomach Relief 262 mg 63868-0622-30 CDMA- 30 tablets — — FDA listed —
Pepto-Bismol Chewable, TRAVEL BASIX 262 mg 66715-6423-02 Lil' 2 tablets — — FDA listed —
Pepto-Bismol Chewable, CVP HEALTH 262 mg 66715-6523-02 Lil' 2 tablets — — FDA listed —
Stomach Relief, 24-7 Life by 7-Eleven 262 mg 66715-8153-03 Lil' 2 tablets — — FDA listed —
Pepto-Bismol 262 mg 66715-9723-02 Lil' 2 tablets — — FDA listed —
WinCo FOODS Stomach Relief 262 mg 67091-0364-30 WINCO 6 tablets — — FDA listed —
Pepto Bismol 262 mgthis 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

🏛️
2016
On the market since
Sep 2016
📍
2026
Currently FDA-listed
10 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color pink
ShapeRound
ImprintPepto;Bismol
Size16 mm
ScoringNot scored
FlavorWintergreen
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.

🧪 Avoiding an ingredient? See Bismuth Subsalicylate inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII LMI26O6933
    Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
  • UNII H0G9379FGK
    Calcium carbonate is a white mineral powder used as a filler and buffering agent in medicines. It helps give tablets their bulk and size while neutralizing stomach acid in some formulations.
  • UNII 2LRS185U6K
    D&C Red No. 27 is a synthetic red colorant used in medicines and cosmetics. It gives tablets, capsules, or liquids their red or reddish color so products are visually identifiable.
  • 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 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • 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 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 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.

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

The official label also statescalcium carbonate, D&C red No. 27 aluminum lake, flavor, magnesium stearate, mannitol, povidone, saccharin sodium, talc

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.

Manufacturer & labeler

LabelerNavajo Manufacturing Company Inc.
FDA applicationM008 (OTC MONOGRAPH DRUG)
Labeler code67751
First marketedSep 2016
Product typeHuman Otc Drug
Portfolio60 products on file

More NDCs from Navajo Manufacturing Company Inc. labeler code 67751

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 30 words ▾

Uses Relieves • travelers' diarrhea • diarrhea • upset stomach due to overindulgence in food and drink, including: • heartburn • indigestion • nausea • gas • belching • fullness

⏱️ Dosage and Administration 68 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 exceed 8 doses (16 tablets) 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 214 words ▾

Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Contains salicylate.

Do not take if you are • allergic to salicylates (including aspirin) • taking other salicylate products Do not use if you have • an ulcer • a bleeding problem • bloody or black stool Ask a doctor before use if you have • fever • mucus in the stool Ask a doctor or pharmacist before use if you are taking any drug for • anticoagulation (thinning the blood) • diabetes • gout • arthritis 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 or last more than 2 days • 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 16 words ▾

Active ingredient (in each Chewable tablet) Bismuth subsalicylate 262 mg Purpose Upset stomach reliever and antidiarrheal

🧪 Inactive Ingredients 18 words ▾

Inactive ingredients calcium carbonate, D&C red No. 27 aluminum lake, flavor, magnesium stearate, mannitol, povidone, saccharin sodium, talc

🎯 Purpose 6 words ▾

Purpose Upset stomach reliever and antidiarrheal

📄 Do Not Use 18 words ▾

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

📄 Ask a Doctor Before Use If 15 words ▾

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

📄 Ask a Doctor or Pharmacist Before Use If 25 words ▾

Ask a doctor or pharmacist before use if you are taking any drug for • anticoagulation (thinning the blood) • diabetes • gout • arthritis

📄 When Using This Product 16 words ▾

When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur

📄 Stop Use and Ask a Doctor If 34 words ▾

Stop use and ask a doctor if • symptoms get worse or last more than 2 days • ringing in the ears or loss of hearing occurs • diarrhea lasts more than 2 days

🤰 If Pregnant or Breast-Feeding 10 words ▾

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

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 2 words ▾

Questions? 1-800-717-3786

📄 Package Label / Principal Display Panel 3 words ▾

Package Labeling: Pepto

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

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Pepto Bismol (this brand).

Top reported reactions

Osteoporosis130
Nausea119
Diarrhoea99
Vomiting97
Depression84
Arthritis81
Abdominal Pain72

Age at onset

Adolescent2
Adult39
Elderly48

Reporter sex

895 reports
Male · 40%
Female · 60%
Unknown · 0%

Serious outcomes

Hospitalization394
Death131
Disabling118
Life-threatening58
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 54 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.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Navajo Manufacturing Company Inc.. 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 tablets (67751-0155-06), 4 tablets (67751-0155-02). 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?
Navajo Manufacturing Company Inc. 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.
← 67751-0153-02 · Navajo 67751-0162-01 · Navajo →
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.