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Imodium A-D Loperamide hydrochloride 2 mg Tablet, Film Coated — NDC 50580-0317-12 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Imodium A-D Loperamide hydrochloride 2 mg Tablet, Film Coated — NDC 50580-317-12 (Billing 50580-0317-12)

by Kenvue Brands LLC · 2 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED in 1 BLISTER PACK

This is a package of Imodium A-D Loperamide hydrochloride 2 mg Tablet, Film Coated from Kenvue Brands LLC, marketed since Jul 2015 and currently FDA-listed.

NDC 50580-0317-12
🏷️ FDA NDC (as labeled) 50580-317-12 billing pads the product segment with a zero
This package
Contains6 tablet, film coated in 1 blister pack Pack sizes4 compare ↓
Product page 50580-0317-01 Also comes in: 6 tablets 50580-317-01 6 tablets 50580-317-03 6 tablets 50580-317-06
OTC Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 50580-317-12 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
50580 labeler · 317 product · 12 package
Package marketed since
Jan 29, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5058031712 9
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50580-317-12
Product NDC 50580-317
11-digit billing NDC 50580031712
RxCUI 978010, 978013
UNII 77TI35393C
Application # ANDA075232
SPL Set ID 01da76d0-1979-4c45-9d39-c72ae4e4ffe2
Established class (EPC) Opioid Agonist
Mechanism of action Opioid Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-07-13
Route ORAL
Dosage form TABLET, FILM COATED
Substance LOPERAMIDE HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 47100020100305
GCN Seq No 013672
GCN 08550
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 2 MG CAPLET
FDB brand name Imodium A-D
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 013672
  • GCN: 08550
  • GPI-14 (Medi-Span): 47100020100305
  • HICL (First Databank): 001236
  • AHFS class code: 56:08.00.00
  • RxCUI (RxNorm): 978010
Why two NDCs? The FDA registers this code as 50580-317-12 — 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 → 50580-0317-12. 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.

Clinical

Label name IMODIUM A-D 2 MG CAPLET Ingredient Loperamide Hcl
📗 Our plain-language guide HelloPharmacist
  • It controls the symptoms of diarrhea, including travelers' diarrhea in over-the-counter products. Prescription-labeled capsules are also used for chronic diarrhea in adults with in...
  • Take it by mouth, usually after loose stools, following the label chart for your age and weight. Drink lots of clear fluids so you don't get dehydrated. With liquids, shake well an...
  • No. Taking more than directed can cause serious, even fatal, heart rhythm problems. If diarrhea lasts more than 2 days or gets worse, stop and call your doctor.
  • Can I take extra if the diarrhea isn't stopping?
📖 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.

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 eachPer 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: 6 tablets 6 tablets 6 tablets
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
50580-0317-01 50580-317-01 Main listing 1 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED in 1 BLISTER PACK 2015-07-13 — Active
50580-0317-03 50580-317-03 4 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED in 1 BLISTER PACK 2015-07-13 — Active
50580-0317-06 50580-317-06 2 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED in 1 BLISTER PACK 2020-02-10 — Active
50580-0317-12 You're viewing this 2 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED in 1 BLISTER PACK 2024-01-29 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 2 blister pack in 1 carton / 6 tablet, film coated in 1 blister pack.
What NDC number is used to bill for this package of Imodium A-D Loperamide hydrochloride 2 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Good Sense anti diarrheal 2 mg 00113-0224-53 L. 1 tablet $0.130 — Availability likely —
anti diarrheal 2 mg 00113-2224-62 L. 1 tablet $0.130 — Availability likely —
anti diarrheal 2 mg 00904-7725-12 Major 1 tablet $0.130 — Availability likely —
Loperamide Hydrochloride 2 mg 46122-0738-53 Amerisource 12 tablets $0.130 — Availability likely —
leader anti diarrheal 2 mg 70000-0589-01 Cardinal 1 tablet $0.130 — Availability likely —
foster and thrive anti diarrheal 2 mg 70677-1106-01 Strategic 1 tablet $0.130 — Availability likely —
Anti Diarrheal 2 mg 83324-0064-12 Chain 12 tablets $0.130 — Availability likely —
Anti Diarrheal 2 mg 63868-0559-12 CHAIN 12 tablets $0.147 — FDA listed —
injoy diarrhea relief 2 mg 00113-6004-62 L. 1 tablet — — FDA listed —
Anti-Diarrheal 2 mg 00363-0375-02 Walgreen 12 tablets — — FDA listed —
anti diarrheal 2 mg 00363-1010-53 Walgreen 1 tablet — — FDA listed —
Up and Up anti diarrheal 2 mg 11673-0224-02 Target 24 tablets — — Discontinued —
Anti-Diarrheal 2 mg 11822-0375-03 Rite 12 tablets — — FDA listed —
Anti-Diarrheal 2 mg 21130-0375-08 Better 24 tablets — — FDA listed —
Loperamide Hydrochloride 2mg 2 mg 25000-0001-83 MARKSANS 24 tablets — — FDA listed —
Anti-Diarrheal 2 mg 29485-9286-02 Lil' 25 tablets — — FDA listed —
Anti-Diarrheal 2 mg 30142-0775-02 Kroger 12 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 35418-0123-12 Zee 12 tablets — — FDA listed —
topcare anti diarrheal 2 mg 36800-0224-53 Topco 1 tablet — — FDA listed —
Anti-Diarrheal 2 mg 37808-0375-08 H 24 tablets — — FDA listed —
Anti Diarrheal 2 mg 37808-0552-23 H 72 tablets — — Discontinued —
Anti-diarrheal 2 mg 37835-0131-01 BI-MART 100 tablets — — FDA listed —
Anti-Diarrheal 2 mg 41163-0375-02 United 12 tablets — — FDA listed —
anti diarrheal 2 mg 41250-0224-53 Meijer 1 tablet — — FDA listed —
CareOne Diarrhea Control 2 mg 41520-0813-53 American 1 tablet — — FDA listed —
anti diarrheal 2 mg 42507-0224-53 HyVee 1 tablet — — FDA listed —
MEDIQUE Diamode 2 mg 47682-0200-33 Unifirst 100 tablets — — Discontinued —
MEDIQUE Diamode 2 mg 47682-0400-46 Unifirst 1 tablet — — FDA listed —
Anti Diarrheal 2 mg 49035-0375-08 Wal-Mart 24 tablets — — FDA listed —
Imodium A-D 2 mgthis 50580-0317-12 Kenvue 6 tablets — — FDA listed —
Anti-Diarrheal 2 mg 50844-0259-02 L.N.K. 12 tablets — — FDA listed —
Anti-diarrheal 2 mg 50844-0375-02 L.N.K. 12 tablets — — FDA listed —
Loperamide HCl 2 mg 50844-0735-02 L.N.K. 12 tablets — — FDA listed —
Good Sense anti diarrheal 2 mg 51655-0663-54 Northwind 15 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 51660-0123-06 Ohm 6 tablets — — FDA listed —
Anti-Diarrheal 2 mg 53117-0248-86 First 6 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 53329-0664-57 Medline 12 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 53943-0123-12 Discount 12 tablets — — FDA listed —
Anti-Diarrheal 2 mg 53943-0375-02 Discount 12 tablets — — FDA listed —
Anti Diarrheal 2 mg 55301-0375-02 ARMY 12 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 55315-0123-06 Fred's 6 tablets — — FDA listed —
Anti-Diarrheal 2 mg 55319-0375-08 Family 24 tablets — — FDA listed —
dg health anti diarrheal 2 mg 55910-0224-23 Dolgencorp, 72 tablets — — Discontinued —
Anti-Diarrheal 2 mg 55910-0375-08 DOLGENCORP, 24 tablets — — FDA listed —
anti diarrheal 2 mg 56062-0224-53 Publix 1 tablet — — FDA listed —
Anti-Diarrheal 2 mg 57896-0381-13 Geri-Care 12 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 58602-0701-01 Aurohealth 6 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 58602-0870-76 Aurohealth 24 tablets — — FDA listed —
anti diarrheal 2 mg 59779-0700-53 CVS 1 tablet — — FDA listed —
anti diarrheal 2 mg 59779-0960-62 CVS 1 tablet — — FDA listed —
Loperamide Hydrochloride 2 mg 63187-0462-12 Proficient 12 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 63868-0338-12 Chain 12 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 63941-0123-12 Valu 12 tablets — — FDA listed —
Anti-Diarrheal 2 mg 63941-0375-02 Valu 12 tablets — — FDA listed —
Anti-Diarrheal 2 mg 66424-0725-24 SDA 24 tablets — — FDA listed —
Anti-Diarrheal, 24/7 Life by 7-Eleven 2 mg 66715-4644-04 Lil' 12 tablets — — FDA listed —
Anti-Diarrheal, Circle K 2 mg 66715-5529-02 Lil' 4 tablets — — FDA listed —
Anti-Diarrheal, Caseys 4good 2 mg 66715-6359-02 Lil' 4 tablets — — FDA listed —
Anti-Diarrheal, CVP HEALTH 2 mg 66715-6559-02 Lil' 4 tablets — — FDA listed —
Lil Drug Store Anti-Diarrheal 2 mg 66715-9859-02 Lil' 2 tablets — — FDA listed —
Anti-Diarrheal 2 mg 67091-0335-18 WinCo 12 tablets — — FDA listed —
anti diarrheal 2 mg 67296-1472-07 Redpharm 24 tablets — — FDA listed —
Handy Solutions Anti-Diarrheal 2 mg 67751-0162-01 Navajo 1 tablet — — FDA listed —
Loperamide Hydrochloride 2 mg 68016-0123-06 Chain 6 tablets — — FDA listed —
Anti-diarrheal 2 mg 68016-0301-06 Chain 6 tablets — — Discontinued —
berkley and jensen anti diarrheal 2 mg 68391-0224-01 BJWC 96 tablets — — Discontinued —
Loperamide Hydrochloride 2 mg 68788-8393-02 Preferred 24 tablets — — FDA listed —
Good Sense anti diarrheal 2 mg 68788-8750-02 Preferred 1 tablet — — FDA listed —
Loperamide Hydrochloride 2 mg 68998-0123-24 Marc 24 tablets — — FDA listed —
Anti-Diarrheal 2 mg 69168-0248-86 Allegiant 6 tablets — — FDA listed —
Leader Anti Diarrheal 2 mg 70000-0225-01 Cardinal 1 tablet — — Discontinued —
Good Sense anti diarrheal 2 mg 71205-0079-12 Proficient 1 tablet — — FDA listed —
MEDIQUE Diamode 2 mg 71205-0316-01 Proficient 1 tablet — — FDA listed —
basic care loperamide hydrochloride 2 mg 72288-0224-62 Amazon.com 1 tablet — — FDA listed —
Amazon Basic Care Loperamide Hydrochloride 2 mg 72288-0225-76 Amazon.com 24 tablets — — FDA listed —
WELMATE Anti Diarrheal Loperamide HCl 2 mg 73581-0101-24 YYBA 24 tablets — — FDA listed —
Anti Diarrheal 2 mg 73581-0171-24 Yyba 24 tablets — — FDA listed —
Anti-Diarrheal 2 mg 80136-0063-11 Heartland 24 tablets — — FDA listed —
Anti-Diarrheal 2 mg 80513-0375-08 Advanced 24 tablets — — FDA listed —
Anti-Diarrheal 2 mg 80513-0401-24 Advanced 24 tablets — — FDA listed —
Amazon Basic Care Loperamide Hydrochloride 2 mg 82804-0295-06 Proficient 6 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 84386-0117-24 Aurobindo 24 tablets — — FDA listed —
Anti-Diarrheal 2 mg 84441-0711-02 IMO-GEN 200 tablets — — FDA listed —
MEDIQUE Diamode 2 mg 85766-0120-01 Sportpharm 1 tablet — — FDA listed —
Loperamide Hydrochloride 2 mg 85766-0154-06 Sportpharm 6 tablets — — FDA listed —
Anti-Diarrheal 2 mg 85828-0248-93 Grocery 12 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 73581-0175-24 YYBA 24 tablets — — FDA listed —
Anti-Diarrheal 2 mg 41226-0797-22 Kroger 6 tablets — — 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

🏛️
2015
On the market since
Jul 2015
📍
2026
Currently FDA-listed
11 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.

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 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • UNII R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • 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 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.

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

The official label also statesanhydrous lactose, carnauba wax, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch

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.

Manufacturer & labeler

LabelerKenvue Brands LLC
Application holderL PERRIGO CO
FDA applicationANDA075232 (ANDA)
Labeler code50580
First marketedJul 2015
Product typeHuman Otc Drug
Portfolio567 products on file

More NDCs from Kenvue Brands LLC labeler code 50580

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.

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 134 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. adults and children 12 years and over 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours children 9-11 years (60-95 lbs) 1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours children 6-8 years (48-59 lbs) 1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets 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 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 16 words ▾

Other information store at 20°-25°C (68°-77°F) do not use if blister unit is broken or torn

🧪 Active Ingredient 9 words ▾

Active ingredient (in each caplet) Loperamide HCl 2 mg

🧪 Inactive Ingredients 15 words ▾

Inactive ingredients anhydrous lactose, carnauba wax, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch

🎯 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 ↗

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

Diarrhoea8,805
Nausea4,255
Fatigue3,846
Vomiting2,747
Constipation2,438
Weight Decreased2,071
Headache1,994

Age at onset

Neonate13
Infant21
Child95
Adolescent98
Adult4,320
Elderly5,224

Reporter sex

44,211 reports
Male · 38%
Female · 62%
Unknown · 0%

Serious outcomes

Hospitalization15,989
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.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 3 other package presentations of this same product, including 6 tablets (50580-0317-01), 6 tablets (50580-0317-03), 6 tablets (50580-0317-06). 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.
← 50580-0309-01 · Kenvue 50580-0322-20 · Kenvue →
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.