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loperamide hydrochloride loperamide HCl 1 mg/7.5mL Solution, 240 mL — NDC 11822-5519-03 package photo

loperamide hydrochloride loperamide HCl 1 mg/7.5mL Solution, 240 mL

by Rite Aid Corporation · 240 mL in 1 BOTTLE (11822-5519-3)
NDC 11822-5519-03
🏷️ FDA NDC (as labeled) 11822-5519-3 billing pads the package segment with a zero
This package
Contains240 mL Pack sizes3 compare ↓
Also comes in: 120 ml 11822-5519-01 240 ml 11822-5519-02
OTC Generic 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 →

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. 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) 11822-5519-3
Product NDC 11822-5519
11-digit billing NDC 11822551903
RxCUI 1250685
UNII 77TI35393C
Application # ANDA091292
SPL Set ID 56334ed4-8cb0-4f5c-9051-6836f0e21337
Established class (EPC) Opioid Agonist
Mechanism of action Opioid Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2018-06-18
Route ORAL
Dosage form SOLUTION
Substance LOPERAMIDE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 11822-5519-3 — 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 → 11822-5519-03. 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 Opioid Agonist class.

Pharmacologic class Opioid Agonist
Drug family (ATC) Antipropulsives
How it works Opioid Agonists
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

LabelerRite Aid Corporation
Application holderPERRIGO R AND D CO
FDA applicationANDA091292 (ANDA)
Labeler code11822
First marketedJun 2018
Product typeHuman Otc Drug
Portfolio326 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
  • Loperamide works by binding to the same type of receptors in your gut that opioids do, but it stays mostly in the intestines and very little gets into your bloodstream at the recom...
  • What exactly does loperamide do — and is it like taking an opioid?
  • For acute diarrhea, stop and call your doctor if symptoms don't improve within 2 days, or if they get worse. You should also stop right away if you develop bloating or a swollen be...
  • How long can I take loperamide before I should see a doctor?
📖 Read our full Loperamide guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

💊 What it looks like

Color Green
FlavorMint
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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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.
Try another pack size: 120 ml 240 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
Good Sense antidiarrheal 1 mg/7.5mL 00113-1645-26 L. 120 ml $0.026 — Availability likely —
loperamide hydrochloride 1 mg/7.5mL 00904-6836-20 Major 120 ml $0.026 — Availability likely —
good neighbor pharmacy loperamide hydrochloride 1 mg/7.5mL 46122-0544-26 Amerisource 120 ml $0.026 — Availability likely —
leader anti diarrheal 1 mg/7.5mL 70000-0417-01 Cardinal 120 ml $0.026 — Availability likely —
leader anti diarrheal 1 mg/7.5mL 70000-0418-01 Cardinal 120 ml $0.026 — Availability likely —
foster and thrive anti-diarrheal 1 mg/7.5mL 70677-1107-01 Strategic 1 bottle $0.026 — Availability likely —
Anti Diarrheal 1 mg/7.5mL 00363-2022-26 Walgreen 120 ml — — FDA listed —
Up and Up anti diarrheal 1 mg/7.5mL 11673-0900-34 Target 240 ml — — FDA listed —
loperamide hydrochloride 1 mg/7.5mLthis 11822-5519-03 Rite 240 ml — — Discontinued —
loperamide hydrochloride 1 mg/7.5mL 17856-6836-01 ATLANTIC 72 cups — — FDA listed —
anti-diarrheal 1 mg/7.5mL 21130-0381-34 Safeway 240 ml — — FDA listed —
signature care anti diarrheal 1 mg/7.5mL 21130-0440-34 Safeway 1 bottle — — Discontinued —
anti diarrheal 1 mg/7.5mL 30142-0514-34 Kroger 236 ml — — FDA listed —
topcare loperamide hydrochloride 1 mg/7.5mL 36800-0583-26 Topco 120 ml — — FDA listed —
anti diarrheal 1 mg/7.5mL 37808-0449-34 H 240 ml — — FDA listed —
equaline loperamide hydrochloride 1 mg/7.5mL 41163-0210-26 United 120 ml — — FDA listed —
loperamide hydrochloride 1 mg/7.5mL 41250-0813-26 Meijer 120 ml — — FDA listed —
CareOne Diarrhea Control 1 mg/7.5mL 41520-0841-26 American 120 ml — — FDA listed —
Equate Loperamide Hydrochloride 1 mg/7.5mL 49035-0451-34 Wal-Mart 240 ml — — FDA listed —
equate diarrhea control 1 mg/7.5mL 49035-0695-26 Wal-Mart 118 ml — — FDA listed —
Imodium A-D 1 mg/7.5mL 50580-0134-04 Kenvue 120 ml — — FDA listed —
Loperamide Hydrochloride 1 mg/7.5mL 55910-0155-55 DOLGENCORP 120 ml — — FDA listed —
DG Health Anti Diarrheal 1 mg/7.5mL 55910-0867-26 Dolgencorp 118 ml — — FDA listed —
Loperamide Hydrochloride 1 mg/7.5mL 68094-0029-62 Precision 10 cups — — FDA listed —
Loperamide Hydrochloride 1 mg/7.5mL 68094-0129-62 Precision 10 cups — — FDA listed —
loperamide hydrochloride 1 mg/7.5mL 68788-7842-01 Preferred 120 ml — — FDA listed —
Good Sense antidiarrheal 1 mg/7.5mL 68788-8796-01 Preferred 120 ml — — FDA listed —
loperamide hydrochloride oral 1 mg/7.5mL 69452-0405-55 BIONPHARMA 120 ml — — FDA listed —
Loperamide hydrochloride 1 mg/7.5mL 69842-0191-26 CVS 120 ml — — FDA listed —
basic care loperamide hydrochloride 1 mg/7.5mL 72288-0645-34 Amazon.com 240 ml — — FDA listed —
basic care loperamide hydrochloride 1 mg/7.5mL 72288-0758-26 Amazon.com 120 ml — — FDA listed —
Loperamide Hydrochloride 1 mg/7.5mL 81033-0067-34 Kesin 30 cups — — FDA listed —
Loperamide Hydrochloride 1 mg/7.5mL 72288-0048-34 Amazon.com 240 ml — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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
Jun 2018
📍
2026
Currently FDA-listed
8 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Loperamide (matched by generic name) — the program that covers self-administered drugs. 10 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Loperamide. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$3.64M
Claims incl. refills
241.9K
Beneficiaries
170.9K
Spend / beneficiary
$21.31
Spend / claim
$15.06
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
11822-5519-01 120 mL in 1 BOTTLE (11822-5519-1) 2018-06-18 Discontinued by firm
11822-5519-03 You're viewing this 240 mL in 1 BOTTLE (11822-5519-3) 2020-03-01 Discontinued by firm
11822-5519-02 240 mL in 1 BOTTLE (11822-5519-2) 2018-06-18 Active

Pack size FAQ

What quantity is in NDC 11822-5519-03?
NDC 11822-5519-03 contains 240 mL — 240 ml in 1 bottle.
What is the difference between NDC 11822-5519-03 and NDC 11822-5519-01?
Both are loperamide hydrochloride loperamide HCl 1 mg/7.5mL Solution — the drug itself is identical. NDC 11822-5519-03 is the 240 mL package, while NDC 11822-5519-01 is the 120 ml package.
What NDC number is used to bill for this package of loperamide hydrochloride loperamide HCl 1 mg/7.5mL Solution?
Bill NDC 11822-5519-03 — the 11-digit billing format is 11822551903. 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 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) — 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

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 11822-5519-3, 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: 11822-5519-03, written without dashes as 11822551903. 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 11822-5519-03, the first segment (11822) is the labeler code FDA assigned to Rite Aid Corporation; the middle segment (5519) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 120 ml (11822-5519-01), 240 ml (11822-5519-02). 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?
Rite Aid Corporation 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 8 words ▾

Use controls symptoms of diarrhea, including Travelers’ Diarrhea

⏱️ Dosage and Administration 165 words ▾

Directions • drink plenty of clear fluids to help prevent dehydration caused by diarrhea • find right dose on chart. If possible, use weight to dose; otherwise use age. • shake well before using • use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device. • mL = milliliter adults and children 12 years and over 30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hours children 9-11 years (60-95 lbs) 15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours children 6-8 years (48-59 lbs) 15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL in 24 hours children 2-5 years (34 to 47 lbs) ask a doctor children under 2 years (up to 33 lbs) do not use

⚠️ Warnings 168 words ▾

Warnings Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl Heart alert: Taking more than directed can cause serious heart problems or death Do not use Ask a doctor before use if you have • fever • mucus in the stool • a history of liver disease • a history of abnormal heart rhythm Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs. When using this product tiredness, drowsiness or dizziness may occur.

Be careful when driving or operating machinery. Stop use and ask a doctor if • symptoms get worse • diarrhea lasts for more than 2 days • you get abdominal swelling or bulging. These may be signs of a serious condition.

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.

(1-800-222-1222)

📦 Storage and Handling 19 words ▾

Other information • each 30 mL contains: sodium 15 mg • store between 20-25 ° C (68-77 ° F)

🧪 Active Ingredient 10 words ▾

Active ingredient (in each 7.5 mL) Loperamide HCl 1 mg

🧪 Inactive Ingredients 35 words ▾

Inactive ingredients anhydrous citric acid, carboxymethylcellulose sodium, D&C yellow no. 10, FD&C blue no. 1, glycerin, microcrystalline cellulose, natural and artificial mint flavor, propylene glycol, purified water, simethicone, sodium benzoate, sucralose, titanium dioxide, xanthan gum

🎯 Purpose 2 words ▾

Purpose Anti-diarrheal

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 11822-5462-09 · Rite 11822-5533-01 · Rite →
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.