Leader Anti Diarrheal — Tablet, Film Coated

Overview

Brand name

Leader Anti Diarrheal

Generic name

Loperamide HCl

Dosage form

Tablet, Film Coated

Route

Oral

Marketing category

ANDA · ANDA

Labeler

Cardinal Health 110, LLC. dba Leader

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

1

NDC product codes

2

Packages

2

Data completeness

76% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Loperamide Hydrochloride	2 mg/1	978006	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Tablet, Film Coated

Route of administration

Oral

Presentations

4

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Opioid Agonist [EPC]	EPC	All 109 members
Opioid Agonists [MoA]	MoA	All 35 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

075232

Application type

ANDA · Abbreviated New Drug Application

Approval date

January 6, 2000

Sponsor

L PERRIGO CO

Products on application

1

Submissions recorded

10

Products approved under application 075232.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
075232-001	LOPERAMIDE HYDROCHLORIDE	TABLET		LOPERAMIDE HYDROCHLORIDE	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 075232.
Type	No.	Action	Status	Date	Review
Supplement	46	Labeling	Approved	June 8, 2020	Standard
Supplement	44	Labeling	Approved	June 8, 2020	Standard
Supplement	20	Labeling	Approved	October 23, 2007	—
Supplement	6	Labeling	Approved	October 4, 2002	—
Supplement	5	Manufacturing (CMC)	Approved	October 4, 2002	—
Supplement	4	Labeling	Approved	October 4, 2002	—
Supplement	3	Manufacturing (CMC)	Approved	October 4, 2002	—
Supplement	2	Manufacturing (CMC)	Approved	October 4, 2002	—
Supplement	1	Manufacturing (CMC)	Approved	October 4, 2002	—
Original application	1		Approved	January 6, 2000	—

Review documents

0 · Original application · December 28, 2001
0 · Original application · January 6, 2000
0 · Original application · January 6, 2000

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250718). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250718

Indications and Usage

openFDA Drug Labeling

Use controls symptoms of diarrhea, including Travelers’ Diarrhea

Purpose

openFDA Drug Labeling

Purpose Anti-diarrheal

Dosage and Administration

openFDA Drug Labeling

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

openFDA Drug Labeling

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).

Do Not Use

openFDA Drug Labeling

Do not use if you have bloody or black stool

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have • fever • mucus in the stool • a history of liver disease • a history of abnormal heart rhythm

Stop Use

openFDA Drug Labeling

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.

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each caplet) Loperamide HCl 2 mg

Adverse event reports

Source: openFDA FAERS

50,038

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: LOPERAMIDE HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
70000-0225-2	70000-0225	Cardinal Health 110, LLC. dba Leader	12 BLISTER PACK in 1 CARTON (70000-0225-2) / 1 TABLET, FILM COATED in 1 BLISTER PACK	February 2, 2020
70000-0589-1	70000-0589	Cardinal Health 110, LLC. dba Leader	24 BLISTER PACK in 1 CARTON (70000-0589-1) / 1 TABLET, FILM COATED in 1 BLISTER PACK	October 7, 2021
70000-0225	70000-0225	Cardinal Health 110, LLC. dba Leader	—	January 17, 2017
70000-0589	70000-0589	Cardinal Health 110, LLC. dba Leader	—	October 7, 2021

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Drug Labeling	FDA / NLM	Prescribing information reproduced above
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.