Ultra Stomach Relief Bismuth subsalicylate 525 mg/15mL Liquid, 237 mL
by Strategic Sourcing Services LLC · 237 mL in 1 BOTTLE, PLASTIC (62011-0436-1)
NDC 62011-0436-01
🏷️ FDA NDC (as labeled)
62011-0436-1
billing pads the package segment with a zero
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 →
⚠️
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 Sep 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)
62011-0436-1
Product NDC
62011-0436
11-digit billing NDC
62011043601
RxCUI
308763
UNII
62TEY51RR1
UPC
0052569143070
Application #
M008
SPL Set ID
a544ab14-341c-4cb1-9565-57ae57205cb3
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 Sep 2026)
Marketing start
2019-11-29
Route
ORAL
Dosage form
LIQUID
Substance
BISMUTH SUBSALICYLATE
GCN Seq No
002859
GCN
26971
HICL code
001246
Ingredient (HICL)
Bismuth Subsalicylate
HIC1 code
D
Therapeutic class — broad (HIC1)
Biliary System/Gastro-Intestinal System
HIC2 code
D6
Therapeutic class — intermediate (HIC2)
Drugs Acting Principally On The Colon
HIC3 code
D6D
Therapeutic class — specific (HIC3)
Antidiarrheals
AHFS code
56:04.00.00
AHFS class
Antacids And Adsorbents
FDB label name
HM STOMACH RELIEF 525 MG/15 ML
FDB brand name
Stomach Relief
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 62011-0436-1 — a 5-4-1 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 package segment → 62011-0436-01. 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.
🏭 Manufacturer & labeler
LabelerStrategic Sourcing Services LLC
FDA applicationM008 (OTC MONOGRAPH DRUG)
Labeler code62011
First marketedNov 2019
Product typeHuman Otc Drug
Portfolio316 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
Label name HM STOMACH RELIEF 525 MG/15 ML Ingredient Bismuth Subsalicylate
📖 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?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Bismuth Subsalicylate (OTC drug) — tap one for details:
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.
💬 Questions about Bismuth subsalicylate?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.010 | $2.44 / 237 ml |
| 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. | |
NADAC price history (per mL) — tap or hover for the price & month
▲ Up 4% over the last 12 months.
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Stomach Relief Ultra 525 mg/15mL 70000-0045-01 | Cardinal | 355 ml | $0.010 | — | Availability likely | save 7% |
| Ultra Stomach Relief 525 mg/15mLthis 62011-0436-01 | Strategic | 237 ml | $0.010 | — | FDA listed | — |
| Stomach Relief Ultra 525 mg/15mL 00536-1287-36 | Rugby | 237 ml | $0.011 | — | Availability likely | +6% |
| Good Neighbor Ultra Strength Stomach Relief 525 mg/15mL 46122-0747-06 | AMERISOURCE | 236 ml | $0.012 | — | Availability likely | +17% |
| Quality Choice Stomach Relief 528 525 mg/15mL 83324-0021-08 | Chain | 236 ml | $0.012 | — | Availability likely | +17% |
| Walgreen Ultra Strength Pink Bismuth 525 mg/15mL 00363-7070-04 | WALGREENS | 118 ml | — | — | FDA listed | — |
| Walgreen Stomach Relief Ultra Strength 525 mg/15mL 00363-7071-12 | WALGREENS | 354 ml | — | — | FDA listed | — |
| Soothe Ultra Strength 525 mg/15mL 00363-7370-04 | Walgreens | 118 ml | — | — | FDA listed | — |
| Ultra Strenght Pink Bismuth 525 mg/15mL 11673-0907-08 | TARGET | 236 ml | — | — | FDA listed | — |
| RITE AID Ultra Strnght Pink Bismuth 525 mg/15mL 11822-7070-02 | RITE | 354 ml | — | — | FDA listed | — |
| SIGNATURE CARE Ultra Strength Stomach 525 mg/15mL 21130-0193-12 | SAFEWAY | 354 ml | — | — | FDA listed | — |
| Ultra Stomach Relief 525 mg/15mL 21130-0662-08 | Safeway, | 237 ml | — | — | FDA listed | — |
| TopCare Stomach Relief Ultra Strength 525 mg/15mL 36800-0341-08 | TOPCO | 236 ml | — | — | FDA listed | — |
| Pepto-Bismol Ultra 525 mg/15mL 37000-0440-04 | The | 118 ml | — | — | FDA listed | — |
| Pepto-Bismol Ultra Cherry 525 mg/15mL 37000-0441-04 | The | 118 ml | — | — | FDA listed | — |
| HEB Stomach Relief Max Strength 1050 mg/30mL 37808-0770-08 | HEB | 236 ml | — | — | FDA listed | — |
| Equaline Maximum Strength Stomach Relief 1050 mg/30mL 41163-0937-04 | UNITED | 237 ml | — | — | FDA listed | — |
| Meijer Stomach Relief Regular Strength 525 mg/15mL 41250-0211-12 | MEIJER | 354 ml | — | — | FDA listed | — |
| PUBLIX Stomach Relief Ultra Strength 525 mg/15mL 41415-0707-12 | PUBLIX | 354 ml | — | — | FDA listed | — |
| Stomach Relief Ultra 525 mg/15mL 49035-0293-12 | EQUATE | 355 ml | — | — | FDA listed | — |
| Stomach Relief Ultra Strength 525 mg/15mL 49580-0842-08 | P | 237 ml | — | — | FDA listed | — |
| Goodsense maximum strength Stomach Relief 528 1050 mg/30mL 50804-0154-04 | Good | 236 ml | — | — | FDA listed | — |
| CVS Stomach Relief Ultra Strength 525 mg/15mL 51316-0707-12 | CVS | 354 ml | — | — | FDA listed | — |
| Maximum Strength Stomach Relief 1050 mg/30mL 53041-0528-04 | Guardian | 236 ml | — | — | FDA listed | — |
| Ultra Strength Stomach Relief 525 mg/15mL 53041-0529-04 | Guardian | 236 ml | — | — | FDA listed | — |
| Stomach Relief Maximum Strength 1050 mg/30mL 53942-0558-26 | Demoulas | 237 ml | — | — | FDA listed | — |
| Maximum Strength Pink Bismuth 1050 mg/30mL 53943-0528-05 | Discount | 354 ml | — | — | FDA listed | — |
| Stomach Relief Ultra 525 mg/15mL 55319-0948-08 | Family | 237 ml | — | — | FDA listed | — |
| Kaopectate Max Peppermint Flavor Anti Diarrheal 525 mg/15mL 55505-0200-36 | Kramer | 236 ml | — | — | FDA listed | — |
| Kaopectate 525 mg/15mL 55505-0229-64 | KRAMER | 325 ml | — | — | FDA listed | — |
| Ultra Bismuth 525 mg/15mL 55910-0637-04 | Dolgencorp, | 118 ml | — | — | FDA listed | — |
| Stomach Relief Ultra 525 mg/15mL 55910-0837-08 | Dolgencorp, | 237 ml | — | — | FDA listed | — |
| QC Stomach Relief Regular Strength 525 mg/15mL 63868-0304-08 | QUALITY | 236 ml | — | — | FDA listed | — |
| Stomach Relief Ultra Strength 525 mg/15mL 63868-0813-08 | QUALITY | 237 ml | — | — | Discontinued | — |
| Stomach Relief Ultra 525 mg/15mL 63941-0737-04 | Best | 118 ml | — | — | FDA listed | — |
| WinCo FOODS Ultra Strength Stomach Relief 525 mg/15mL 67091-0363-24 | WINCO | 236 ml | — | — | FDA listed | — |
| DRx Choice Stomach Relief Regular Strength 525 mg/15mL 68163-0707-12 | RARITAN | 354 ml | — | — | FDA listed | — |
| Stomach Relief, Ultra Strength 1050 mg/30mL 68998-0558-28 | Marc | 354 ml | — | — | FDA listed | — |
| Max Strength Stomach Relief 1050 mg/30mL 69256-0528-04 | Harris | 236 ml | — | — | FDA listed | — |
| Pepto Bismol Ultra 525 mg/15mL 69423-0966-12 | The | 354 ml | — | — | FDA listed | — |
| Stomach Relief Maximum Strength 525 mg/15mL 69842-0229-12 | CVS | 355 ml | — | — | FDA listed | — |
| Ultra Strength Stomach Relief 525 mg/15mL 72476-0528-04 | Retail | 236 ml | — | — | FDA listed | — |
| Stomach Relief Ultra Strength 525 mg/15mL 72476-0737-08 | Care | 237 ml | — | — | FDA listed | — |
| Topcare Ultra Strength Stomach Relief 525 mg/15mL 76162-0022-04 | Topco | 236 ml | — | — | FDA listed | — |
| Stomach Relief - Maximum Strength 1050 mg/30mL 76281-0538-26 | AptaPharma | 237 ml | — | — | FDA listed | — |
| Stomach Relief, Maximum Strength 1050 mg/30mL 76281-0558-25 | AptaPharma | 177 ml | — | — | FDA listed | — |
| Quality Choice Ultra Strength Stomach Relief 525 mg/15mL 83324-0337-08 | QUALITY | 236 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
🏛️
2019
On the market since
Nov 2019
📍
2026
Currently FDA-listed
7 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 Ultra Stomach Relief (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 44%
Female · 56%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 62011-0436-01 You're viewing this | 237 mL in 1 BOTTLE, PLASTIC (62011-0436-1) | 2019-11-29 | 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 | ✓ Available |
| 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) | ✓ Available |
| 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.
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 62011-0436-1, 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: 62011-0436-01, written without dashes as 62011043601. 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 62011-0436-01, the first segment (62011) is the labeler code FDA assigned to Strategic Sourcing Services LLC; the middle segment (0436) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Strategic Sourcing Services 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
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses relieves travelers' diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas fullness belching
⏱️ Dosage and Administration ▾
Directions do not take more than 8 doses (120 mL) 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 mL = milliliter shake well before using measure only with dosing cup provided. Do not use any other dosing device keep dosing cup with product adults and children 12 years and over: 15 mL (1dose) every 1/2 or 30 mL (2 doses) every hour as needed diarrhea/traveler's diarrhea 15 mL (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) children under 12 years of age: ask a doctor
⚠️ Warnings ▾
Warnings Reye's syndrome : Children and teenagers who have or are recovering from chicken pox or flu-like symptoms ahould 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 diabetes gout arthritis anticoagulation (thinning the blood) When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur. Stop use and ask a doctor if symptoms get worse 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 childen. In case of overdose, get medical help or contact a Posion Control Center (1-800-222-1222) right away.
📦 Storage and Handling ▾
Other information each 15 mL contains : sodium 5 mg each 15 mL contains : salicylate 206 mg low sodium keep tightly closed protect from freezing avoid excessive heat (over 104ºF or 40ºC)
🧪 Active Ingredient ▾
Active ingredient (in each 15 mL) Bismuth subsalicylate 525 mg
🧪 Inactive Ingredients ▾
Inactive ingredients benzoic acid, D&C red #22, D&C red #28, flavor, glycerin, purified water, sucralose, xanthan gum
🎯 Purpose ▾
Purpose Upset stomach reliever/Antidiarrheal
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.