Imodium A-D Loperamide Hydrochloride 1 mg/7.5mL Solution, 120 mL
by Kenvue Brands LLC · 120 mL in 1 BOTTLE (50580-134-44)
NDC 50580-0134-44
🏷️ FDA NDC (as labeled)
50580-134-44
billing pads the product segment with a zero
This package
Contains120 mL
Pack sizes3 compare ↓
OTC
Brand
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)
50580-134-44
Product NDC
50580-134
11-digit billing NDC
50580013444
NCPDP billing unit
ML — per mL (volume)
UNII
77TI35393C
UPC
0300450134080
Application #
NDA019487
SPL Set ID
76a976d5-8bee-4158-a94d-7fbfc5544fd4
Established class (EPC)
Opioid Agonist
Mechanism of action
Opioid Agonists
DEA schedule
Non-controlled
Marketing category
NDA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2004-07-01
Route
ORAL
Dosage form
SOLUTION
Substance
LOPERAMIDE HYDROCHLORIDE
GPI-14
47100020102005
GPI class
Imodium A-D
GCN Seq No
059430
GCN
25065
HICL code
001236
Ingredient (HICL)
Loperamide Hcl
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
56:08.00.00
AHFS class
Antidiarrhea Agents
FDB label name
IMODIUM A-D 1 MG/7.5 ML LIQUID
FDB brand name
Imodium A-D
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 50580-134-44 — 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 → 50580-0134-44. 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
LabelerKenvue Brands LLC
Application holderKENVUE BRANDS LLC
FDA applicationNDA019487 (NDA)
Labeler code50580
First marketedJul 2004
Product typeHuman Otc Drug
Portfolio564 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 IMODIUM A-D 1 MG/7.5 ML LIQUID Ingredient Loperamide Hcl
📗 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?
Patient education
Supplement & herbal interactions
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 Loperamide Hydrochloride?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII XF417D3PSL
Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
-
UNII T9D99G2B1R
Caramel is a brown coloring substance made by heating sugar. It's added to medicines to give them color and sometimes a slight sweet taste without affecting how the drug works.
-
UNII K679OBS311
Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
-
UNII 35SW5USQ3G
A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
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UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
-
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 OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
-
UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
-
UNII OJ245FE5EU
Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
-
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 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
-
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.
13 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesanhydrous citric acid, caramel color, D&C yellow no. 10, FD&C blue no. 1, flavor, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, simethicone emulsion, sodium benzoate, sucralose, titanium dioxide, 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 system | Per mL | Per 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
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 |
|---|---|---|---|---|---|---|
| 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/7.5mL 11822-5519-01 | Rite | 120 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/7.5mLthis 50580-0134-44 | 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 | — |
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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
🏛️
2004
On the market since
Jul 2004
📍
2026
Currently FDA-listed
22 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
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 Imodium A-D (this brand).
Top reported reactions
Reporter sex
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 |
|---|---|---|---|
| 50580-0134-04 | 120 mL in 1 BOTTLE (50580-134-04) | 2004-07-01 | Active |
| 50580-0134-08 | 240 mL in 1 BOTTLE (50580-134-08) | 2004-07-01 | Active |
| 50580-0134-44 You're viewing this | 120 mL in 1 BOTTLE (50580-134-44) | 2004-07-01 | Active |
Pack size FAQ
What quantity is in NDC 50580-0134-44?
NDC 50580-0134-44 contains 120 mL — 120 ml in 1 bottle.
What is the difference between NDC 50580-0134-44 and NDC 50580-0134-04?
Both are Imodium A-D Loperamide Hydrochloride 1 mg/7.5mL Solution — the drug itself is identical. NDC 50580-0134-44 is the 120 mL package, while NDC 50580-0134-04 is the 120 ml package.
What NDC number is used to bill for this package of Imodium A-D Loperamide Hydrochloride 1 mg/7.5mL Solution?
Bill NDC 50580-0134-44 — the 11-digit billing format is 50580013444. 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
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 50580-134-44, 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: 50580-0134-44, written without dashes as 50580013444. 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 50580-0134-44, the first segment (50580) is the labeler code FDA assigned to Kenvue Brands LLC; the middle segment (0134) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (44) 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 Kenvue Brands LLC. 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 120 ml (50580-0134-04), 240 ml (50580-0134-08). 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?
Kenvue Brands 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 ▾
Use controls symptoms of diarrhea, including Travelers' Diarrhea
⏱️ Dosage and Administration ▾
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 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 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 ▾
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 if you have bloody or black stool 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 ▾
Other information each 30 mL contains: sodium 16 mg store between 20-25°C (68-77°F) do not use if outer neck band imprinted with "Imodium®" or inner neck band imprinted with "Sealed For Your Safety" is broken or missing
🧪 Active Ingredient ▾
Active ingredient (in each 7.5 mL) Loperamide HCl 1 mg
🧪 Inactive Ingredients ▾
Inactive ingredients anhydrous citric acid, caramel color, D&C yellow no. 10, FD&C blue no. 1, flavor, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, simethicone emulsion, sodium benzoate, sucralose, titanium dioxide, xanthan gum
🎯 Purpose ▾
Purpose Anti-diarrheal
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.