HomeNDC LookupIngredientsBismuth Subsalicylate › 00322-2222-04
Percy Medicine Bismuth Subsalicylate 1050 mg/10mL Liquid, 118 mL — NDC 00322-2222-04 package photo

Percy Medicine Bismuth Subsalicylate 1050 mg/10mL Liquid, 118 mL

by Merrick Medicine Company, Inc · 118 mL in 1 BOTTLE (0322-2222-04)
NDC 00322-2222-04
🏷️ FDA NDC (as labeled) 0322-2222-04 billing pads the labeler segment with a zero
This package
Contains118 mL Pack sizes3 compare ↓
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 →

🆔 Identity & classification

FDA NDC (as labeled) 0322-2222-04
Product NDC 0322-2222
11-digit billing NDC 00322222204
RxCUI 616343, 1233767
UNII 62TEY51RR1
Application # M008
SPL Set ID 08dd53b7-8345-4849-9155-60429cbe2c51
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 2019-09-09
Route ORAL
Dosage form LIQUID
Substance BISMUTH SUBSALICYLATE
Why two NDCs? The FDA registers this code as 0322-2222-04 — a 4-4-2 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 labeler segment → 00322-2222-04. 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.

🏷️ 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

LabelerMerrick Medicine Company, Inc
FDA applicationM008 (OTC MONOGRAPH DRUG)
Labeler code00322
First marketedSep 2019
Product typeHuman Otc Drug
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.

🧪 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 5C5403N26O
    Acacia is a natural gum derived from acacia tree sap. It serves as a binder, thickener, and emulsifier to help hold ingredients together, improve texture, and stabilize the medicine.
  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII PF5DZW74VN
    Calcium hydroxide is a white powder made from limestone. It's used in medicines as a buffer to adjust acidity and as a disintegrant to help tablets break apart in the stomach.
  • UNII E5GY4I6YCZ
    A fragrant liquid extracted from cinnamon bark, used as a flavoring agent to improve the taste of medicines and make them more pleasant to take.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • 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 AKN3KSD11B
    Orange oil obtained by cold pressing orange peel. It serves as a flavoring agent and fragrance in medicines to improve taste and aroma.
  • UNII BQN1B9B9HA
    Potassium carbonate is a white crystalline salt made from potassium and carbonate compounds. It functions as a pH buffer and alkalizing agent in medicines, helping maintain proper acidity levels in liquid formulations.
  • UNII G280W4MW6E
    Rhubarb is a plant extract used as a natural colorant and flavoring agent in medicines. It provides a distinctive color and taste to make the medication more appealing.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • 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.

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

The official label also statesINACTIVE INGREDIENTS: CALCIUM HYDROXIDE, CITRIC ACID, ETHYL ALCOHOL, GLYCERINE, GUM ARABIC, OIL OF CINNAMON, OIL OF ORANGE, POTASSIUM CARBONATE, RHUBARB FLUID EXTRACT, SUGAR, PURIFIED WATER

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 DailyMedingredient 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 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: 90 mL 90 ml
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
Percy Medicine 1050 mg/10mLthis 00322-2222-04 Merrick 118 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
Sep 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 Percy Medicine (this brand).

Top reported reactions

Nausea93
Vomiting76
Diarrhoea70
Abdominal Pain60
Pain53
Constipation48
Abdominal Distension43

Reporter sex

605 reports

Serious outcomes

Death125
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 55 23
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
00322-2222-00 1 BOTTLE in 1 BOX (0322-2222-00) / 90 mL in 1 BOTTLE (0322-2222-03) 2019-09-09 Discontinued by firm
00322-2222-03 90 mL in 1 BOTTLE (0322-2222-03) 2019-09-09 Discontinued by firm
00322-2222-04 You're viewing this 118 mL in 1 BOTTLE (0322-2222-04) 2019-09-09 Active

Pack size FAQ

What quantity is in NDC 00322-2222-04?
NDC 00322-2222-04 contains 118 mL — 118 ml in 1 bottle.
What is the difference between NDC 00322-2222-04 and NDC 00322-2222-03?
Both are Percy Medicine Bismuth Subsalicylate 1050 mg/10mL Liquid — the drug itself is identical. NDC 00322-2222-04 is the 118 mL package, while NDC 00322-2222-03 is the 90 ml package.
What NDC number is used to bill for this package of Percy Medicine Bismuth Subsalicylate 1050 mg/10mL Liquid?
Bill NDC 00322-2222-04 — the 11-digit billing format is 00322222204. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 FDA registers it as 0322-2222-04, 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: 00322-2222-04, written without dashes as 00322222204. 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 00322-2222-04, the first segment (00322) is the labeler code FDA assigned to Merrick Medicine Company, Inc; the middle segment (2222) 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.
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 Merrick Medicine 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 1 bottle (00322-2222-00), 90 ml (00322-2222-03). 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?
Merrick Medicine 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.

📄 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 22 words

Uses: Relieves diarrhea, reduces number of bowel movements. Helps firm stool. Relieves nausea, heartburn, fullness due to overindulgence of food and drink.

⏱️ Dosage and Administration 40 words

Directions (shake well before using) Adults and children 12 yrs and over : 2 teaspoonfuls every hour as needed , not to exceed 4 doses in 24 hours and not more than 2 days. Children under 12: Consult a doctor.

⚠️ Warnings 175 words

Warnings Children and teenagers that have or are recovering from Chicken Pox, flu systems, or flue should NOT use this product. If nausea, vomiting, or fever occur, consult a doctor because these symptoms could be an early sign of Reye Syndrome, a rare but serious condition. Allergy Alert: Contains Salicylates.

Do Not take if you are - allergic to salicylates (including aspirin) - taking other salicylate products. Do not use if you have - blood or black stool - an ulcer - bleeding problem. Ask a doctor before use if you are taking any drug for anti coagulation (thinning of 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 consult a doctor if - symptoms get worse - ringing in the ears or loss of hearing occurs - diarrhea lasts more that 2 days. if pregnant or breast feeding ask a professional before use . In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

🧪 Active Ingredient 8 words

Drug Facts Active Ingredient Active Ingredients Bismuth Subsalicylate

🧪 Inactive Ingredients 27 words

Inactive Ingredients INACTIVE INGREDIENTS: CALCIUM HYDROXIDE, CITRIC ACID, ETHYL ALCOHOL, GLYCERINE, GUM ARABIC, OIL OF CINNAMON, OIL OF ORANGE, POTASSIUM CARBONATE, RHUBARB FLUID EXTRACT, SUGAR, PURIFIED 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 ↗
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.