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Pepto Diarrhea Bismuth subsalicylate 525 mg/30mL Suspension, 118 mL

by The Procter & Gamble Manufacturing Company · 118 mL in 1 BOTTLE, PLASTIC (37000-538-04)
NDC 37000-0538-04
🏷️ FDA NDC (as labeled) 37000-538-04 billing pads the product segment with a zero
OTC Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Jul 2, 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. The listing was last certified through Jun 2026. 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) 37000-538-04
Product NDC 37000-538
11-digit billing NDC 37000053804
UNII 62TEY51RR1
UPC 0301490001660
Application # M008
SPL Set ID 8517edac-fda7-7a49-e053-2a91aa0a24cd
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 (certified through Jun 2026)
Marketing start 2018-03-01
Marketing end 2026-06-30
Route ORAL
Dosage form SUSPENSION
Substance BISMUTH SUBSALICYLATE
Why two NDCs? The FDA registers this code as 37000-538-04 — 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 → 37000-0538-04. 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.

🏭 Manufacturer & labeler

LabelerThe Procter & Gamble Manufacturing Company
FDA applicationM008 (OTC MONOGRAPH DRUG)
Labeler code37000
First marketedMar 2018
Product typeHuman Otc Drug
Portfolio846 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • It's 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.

🧪 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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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 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.
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 70000-0698-01 CARDINAL 236 ml $0.013 — Availability likely —
Pepto Diarrhea 525 mg/30mLthis 37000-0538-04 The 118 ml — — Discontinued —
Stomach Relief Regular Strength 525 mg/30mL 53942-0557-28 Demoulas 354 ml — — FDA listed —
Stomach Relief 525 mg/30mL 57243-0557-26 Consumer 237 ml — — FDA listed —
5-Symptom Digestive Relief 525 mg/30mL 11673-0291-06 TARGET 236 ml — — FDA listed —
Pepto-Bismol Cherry 525 mg/30mL 37000-0439-08 The 236 ml — — FDA listed —
regular strength pink bismuth 525 mg/30mL 69842-0766-12 CVS 354 ml — — FDA listed —
Stomach Relief 525 mg/30mL 85828-0791-07 Grocery 473 ml — — FDA listed —
up and up digestive relief 525 mg/30mL 11673-0706-08 Target 236 ml — — FDA listed —
Rite Aid Regular Strngth Pink Bismuth 525 mg/30mL 11822-7016-06 RITE 473 ml — — FDA listed —
Pepto-Bismol 525 mg/30mL 37000-0438-04 The 118 ml — — FDA listed —
meijer stomach relief regular strength 525 mg/30mL 41250-0670-12 MEIJER 354 ml — — FDA listed —
QC Stomach Relief Cherry Flavor 525 mg/30mL 63868-0305-08 QUALITY 236 ml — — FDA listed —
HEB Stomach Relief Regular Strength 525 mg/30mL 37808-0607-08 H 236 ml — — FDA listed —
AMAZON Regular Strength 525 mg/30mL 72288-0706-16 AMAZON.COM 473 ml — — FDA listed —
meijer stomach relief regular strength 525 mg/30mL 41250-0671-16 MEIJER 473 ml — — FDA listed —
Regular Strength Pink Bismuth 525 mg/30mL 68163-0706-04 Raritan 118 ml — — FDA listed —
Bismuth Subsalicylate Suspension Regular Strength 525 mg/30mL 76281-0557-28 AptaPharma 354 ml — — FDA listed —
TopCare Stomach Relief Regular Strength 525 mg/30mL 36800-0338-08 TOPCO 236 ml — — FDA listed —
Kroger Regular Strength Pink Bismuth 525 mg/30mL 30142-0608-08 KROGER 236 ml — — FDA listed —
TopCare Regular Strength 525 mg/30mL 36800-0661-08 TOPCO 236 ml — — FDA listed —
PUBLIX Regular Strength Pink Bismuth 525 mg/30mL 41415-0706-08 PUBLIX 236 ml — — FDA listed —
WinCo FOODS Stomach Relief 525 mg/30mL 67091-0362-23 WINCO 236 ml — — FDA listed —
Dye Free Regular Strength Stomach Relief 525 mg/30mL 79903-0427-16 Walmart 473 ml — — FDA listed —
RITE AID Regular Strength Pink Bismuth 525 mg/30mL 11822-7060-03 RITE 2 bottles — — FDA listed —
SIGNATURE CARE Regular Strength 525 mg/30mL 21130-0182-12 SAFEWAY 354 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

🏛️
2018
On the market since
Mar 2018
📍
2026
Currently FDA-listed
8 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
37000-0538-04 You're viewing this 118 mL in 1 BOTTLE, PLASTIC (37000-538-04) 2019-03-01 Discontinued by firm

🧭 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 — 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.
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 37000-538-04, 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: 37000-0538-04, written without dashes as 37000053804. 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 37000-0538-04, the first segment (37000) is the labeler code FDA assigned to The Procter & Gamble Manufacturing Company; the middle segment (0538) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
The Procter & Gamble Manufacturing 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 🆘 Overdosage 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 5 words ▾

Uses relieves travelers' diarrhea diarrhea

⏱️ Dosage and Administration 73 words ▾

Directions shake well before use adults and children 12 years and over: 10 mL (1 dose) every ½ hour to 1 hour or 20 mL (2 doses) every hour as needed for diarrhea/travelers’ diarrhea do not exceed 8 doses (80 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 54 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.

🆘 Overdosage 15 words ▾

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

📦 Storage and Handling 28 words ▾

Other information each 10 mL dose contains: salicylate 212 mg low sodium store at no greater than 30°C protect from freezing avoid excessive heat (over 104°F or 40°C)

🧪 Active Ingredient 11 words ▾

Active ingredient (in each 10 mL dose) Bismuth subsalicylate 525 mg

🧪 Inactive Ingredients 27 words ▾

Inactive ingredients benzoic acid, D&C Red No. 22, D&C Red No. 28, flavor, gellan gum, magnesium aluminum silicate, methylcellulose, salicylic acid, sodium salicylate, sorbic acid, sucralose, water

🎯 Purpose 2 words ▾

Purpose Antidiarrheal

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 37000-0537-12 · The 37000-0576-01 · The →
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.