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Stomach Relief Ultra Bismuth subsalicylate 525 mg/15mL Liquid, 355 mL — NDC 70000-0045-01 package photo

Stomach Relief Ultra Bismuth subsalicylate 525 mg/15mL Liquid, 355 mL

by Cardinal Health (Leader) 70000 · 355 mL in 1 BOTTLE, PLASTIC (70000-0045-1)
NDC 70000-0045-01
🏷️ FDA NDC (as labeled) 70000-0045-1 billing pads the package 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) 70000-0045-1
Product NDC 70000-0045
11-digit billing NDC 70000004501
NCPDP billing unit ML — per mL (volume)
RxCUI 308763
UNII 62TEY51RR1
Application # M008
SPL Set ID 5f7a0905-344b-40e1-8b32-171dabb560b3
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 2020-02-25
Route ORAL
Dosage form LIQUID
Substance BISMUTH SUBSALICYLATE
GPI-14 47300010001830
GPI class Stomach Relief Ultra
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 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 70000-0045-1 — 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 → 70000-0045-01. 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

LabelerCardinal Health (Leader) 70000
FDA applicationM008 (OTC MONOGRAPH DRUG)
Labeler code70000
First marketedFeb 2020
Product typeHuman Otc Drug
Portfolio24 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 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?
📖 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.

💡 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 PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • 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.

7 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, glycerin, purified water, sucralose, 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 $0.010 $3.41 / 355 ml
Medicaid paysCMS SDUD · 12 mo $0.0326 $11.57 / 355 ml
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
Jun 2022 Jan 2026 Apr 2026 Aug 2026 $0.010 $0.008
▲ Up 14% over the last 11 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Stomach Relief Ultra 525 mg/15mLthis 70000-0045-01 Cardinal 355 ml $0.010 — Availability likely —
Ultra Stomach Relief 525 mg/15mL 62011-0436-01 Strategic 237 ml $0.010 — Discontinued +7%
Stomach Relief Ultra 525 mg/15mL 00536-1287-36 Rugby 237 ml $0.011 — Availability likely +14%
Good Neighbor Ultra Strength Stomach Relief 525 mg/15mL 46122-0747-06 AMERISOURCE 236 ml $0.012 — Availability likely +26%
Quality Choice Stomach Relief 528 525 mg/15mL 83324-0021-08 Chain 236 ml $0.012 — Availability likely +26%
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

🏛️
2020
On the market since
Feb 2020
📍
2026
Currently FDA-listed
6 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 70000-0045-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
339
Units reimbursed last 4 qtrs
123K
Gross reimbursed last 4 qtrs
$4K
Avg / prescription
$11.84
Avg / unit
$0.0326
Latest quarter Q4 2025
127Rx
Medicaid pays / mL
$0.0326
gross reimbursed
vs
NADAC / mL
$0.0096
acquisition cost
=
Spread
+$0.0230
+240% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
63% FFS 37% MCO
Fee-for-service · 213 Rx Managed care · 126 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 7,100 units · 70.7 per 100k residents MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: 40,679 units · 438 per 100k residents NJ Massachusetts: no data reported MA California: 75,236 units · 193 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
70.7438
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New Jersey 438 /100k
2 California 193 /100k
3 Michigan 70.7 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

🔬 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 Stomach Relief Ultra (this brand).

Top reported reactions

Nausea94
Vomiting76
Diarrhoea71
Abdominal Pain60
Pain53
Constipation48
Abdominal Distension43

Reporter sex

607 reports
Male · 44%
Female · 56%
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 54 24
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
70000-0045-01 You're viewing this 355 mL in 1 BOTTLE, PLASTIC (70000-0045-1) 2020-02-25 Active

📄 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 21 words ▾

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

⏱️ Dosage and Administration 108 words ▾

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 202 words ▾

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 33 words ▾

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 10 words ▾

Active ingredient (in each 15 mL) Bismuth subsalicylate 525 mg

🧪 Inactive Ingredients 17 words ▾

Inactive ingredients benzoic acid, D&C red #22, D&C red #28, flavor, glycerin, purified water, sucralose, xanthan gum

🎯 Purpose 4 words ▾

Purpose Upset stomach reliever/Antidiarrheal

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70000-0044-01 · Cardinal 70000-0046-01 · Cardinal →
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.