HomeNDC LookupIngredientsLoperamide Hcl › 37835-0131-24
Anti-diarrheal Loperamide HCl 2 mg Tablet, 24-count — NDC 37835-0131-24 package photo

Anti-diarrheal Loperamide HCl 2 mg Tablet, 24-count

by BI-MART · 4 BLISTER PACK in 1 CARTON (37835-131-24) / 6 TABLET in 1 BLISTER PACK
NDC 37835-0131-24
🏷️ FDA NDC (as labeled) 37835-131-24 billing pads the product segment with a zero
This package
Contains24-count Pack sizes3 compare ↓
OTC Generic 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) 37835-131-24
Product NDC 37835-131
11-digit billing NDC 37835013124
RxCUI 978010
UNII 77TI35393C
UPC 0071357006557
Application # ANDA076497
SPL Set ID a3687b81-1f4d-49d5-a25f-b16560ab83d8
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 2025-05-01
Route ORAL
Dosage form TABLET
Substance LOPERAMIDE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 37835-131-24 — 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 → 37835-0131-24. 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

LabelerBI-MART
Application holderLNK INTERNATIONAL INC
FDA applicationANDA076497 (ANDA)
Labeler code37835
First marketedMay 2025
Product typeHuman Otc Drug
Portfolio58 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

📖 What it is MedlinePlus · NLM

Nonprescription (over-the-counter) loperamide is used to control acute diarrhea (loose stools that come on suddenly and usually lasts less than 2 weeks), including travelers' diarrhea. Prescription loperamide is also used to control acute diarrhea and also ongoing diarrhea associated with inflammatory bowel disease (IBD; condition in which the lining of all or part of the intestine is swollen, irritated, or has sores). Prescription loperamide is also used to reduce the amount of fluid in people with ileostomies (surgery to create an opening for waste to leave the body through the abdomen). Lop...

Read the full MedlinePlus article ↗
📗 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 →
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
ShapeOval
Imprint44;375
Size1 mm
ScoringScored — splits in 2
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 CQ3XH3DET6
    D&C Yellow No. 10 Aluminum Lake is a yellow colorant made by combining a dye with aluminum salts. It's used in medicines to add color for product identification and visual appeal.
  • UNII O7TSZ97GEP
    A mineral compound that serves as a filler and binding agent in tablets and capsules. It adds bulk to the medicine and helps hold ingredients together during manufacturing.
  • UNII J9EQA3S2JM
    FD&C Blue No. 1 Aluminum Lake is a blue colorant made by combining FD&C Blue No. 1 dye with aluminum salts. It is used to color tablets, capsules, and other medicines for easy identification and appearance.
  • 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

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

The official label also statescorn starch, D&C yellow #10 aluminum lake, dicalcium phosphate dihydrate, FD&C blue #1 brilliant blue lake, magnesium stearate, microcrystalline cellulose, silica gel

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 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: 12 tablets 100 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Good Sense anti diarrheal 2 mg 00113-0224-53 L. 1 tablet $0.133 Availability likely
anti diarrheal 2 mg 00113-2224-62 L. 1 tablet $0.133 Availability likely
anti diarrheal 2 mg 00904-7725-12 Major 1 tablet $0.133 Availability likely
Loperamide Hydrochloride 2 mg 46122-0738-53 Amerisource 12 tablets $0.133 Availability likely
leader anti diarrheal 2 mg 70000-0589-01 Cardinal 1 tablet $0.133 Availability likely
foster and thrive anti diarrheal 2 mg 70677-1106-01 Strategic 1 tablet $0.133 Availability likely
Anti Diarrheal 2 mg 83324-0064-12 Chain 12 tablets $0.133 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 mgthis 37835-0131-24 BI-MART 24 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 mg 50580-0317-01 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
Anti-Diarrheal 2 mg 67296-2314-02 Redpharm 24 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

🏛️
2025
On the market since
May 2025
📍
2026
Currently FDA-listed
1 year 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.

🔬 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 Anti-Diarrheal (this brand).

Top reported reactions

Diarrhoea1,762
Nausea1,042
Fatigue822
Constipation655
Vomiting642
Pyrexia608
Abdominal Pain535

Age at onset

Neonate1
Infant1
Child13
Adolescent28
Adult1,457
Elderly1,226

Reporter sex

13,298 reports
Male · 42%
Female · 58%
Unknown · 0%

Serious outcomes

Hospitalization5,237
Life-threatening846
Disabling259
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 887 0
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
37835-0131-01 100 TABLET in 1 BOTTLE (37835-131-01) 2025-05-01 Active
37835-0131-12 2 BLISTER PACK in 1 CARTON (37835-131-12) / 6 TABLET in 1 BLISTER PACK 2025-05-01 Active
37835-0131-24 You're viewing this 4 BLISTER PACK in 1 CARTON (37835-131-24) / 6 TABLET in 1 BLISTER PACK 2025-05-01 Active

Pack size FAQ

What quantity is in NDC 37835-0131-24?
NDC 37835-0131-24 is a 24-count package — 4 blister pack in 1 carton / 6 tablet in 1 blister pack.
What is the difference between NDC 37835-0131-24 and NDC 37835-0131-12?
Both are Anti-diarrheal Loperamide HCl 2 mg Tablet — the drug itself is identical. NDC 37835-0131-24 is the 24-count package, while NDC 37835-0131-12 is the 12 tablets package.
What NDC number is used to bill for this package of Anti-diarrheal Loperamide HCl 2 mg Tablet?
Bill NDC 37835-0131-24 — the 11-digit billing format is 37835013124. 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 37835-131-24, 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: 37835-0131-24, written without dashes as 37835013124. 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 37835-0131-24, the first segment (37835) is the labeler code FDA assigned to BI-MART; the middle segment (0131) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (24) 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 BI-MART. 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 12 tablets (37835-0131-12), 100 tablets (37835-0131-01). 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?
BI-MART 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 8 words

Use Controls symptoms of diarrhea, including Traveler's Diarrhea

⏱️ Dosage and Administration 132 words

Directions drink plenty of clear liquids 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 (34-47 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 (1-800-222-1222) right away.

📦 Storage and Handling 21 words

Other information do not use if seal around caplet is broken or damaged store between 20º and 25ºC (68º and 77ºF)

🧪 Active Ingredient 9 words

Active ingredient (in each caplet) Loperamide HCl 2 mg

🧪 Inactive Ingredients 24 words

Inactive ingredients corn starch, D&C yellow #10 aluminum lake, dicalcium phosphate dihydrate, FD&C blue #1 brilliant blue lake, magnesium stearate, microcrystalline cellulose, silica gel

🎯 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 ↗
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.