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anti diarrheal

Loperamide Hydrochloride · Tablet, Film Coated

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
anti diarrheal
Generic name
Loperamide Hydrochloride
Dosage form
Tablet, Film Coated
Route
Oral
Marketing category
ANDA · ANDA
Labeler
CVS Pharmacy
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
10
Packages
21
Data completeness
82% 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
31

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@FDANDC 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 20260904). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260904

Indications and Usage

openFDA Drug Labeling

Uses 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
59779-700-53 59779-700 CVS Pharmacy 12 BLISTER PACK in 1 CARTON (59779-700-53) / 1 TABLET, FILM COATED in 1 BLISTER PACK May 12, 2003
59779-700-62 59779-700 CVS Pharmacy 12 BLISTER PACK in 1 CARTON (59779-700-62) / 2 TABLET, FILM COATED in 1 BLISTER PACK November 8, 2022
59779-700-91 59779-700 CVS Pharmacy 6 BLISTER PACK in 1 CARTON (59779-700-91) / 1 TABLET, FILM COATED in 1 BLISTER PACK April 7, 2003
59779-960-62 59779-960 CVS Pharmacy 24 BLISTER PACK in 1 CARTON (59779-960-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK April 21, 2003
37808-552-53 37808-552 H E B 12 BLISTER PACK in 1 CARTON (37808-552-53) / 1 TABLET, FILM COATED in 1 BLISTER PACK February 20, 2020
42507-224-53 42507-224 HyVee Inc 12 BLISTER PACK in 1 CARTON (42507-224-53) / 1 TABLET, FILM COATED in 1 BLISTER PACK March 21, 2003
42507-224-62 42507-224 HyVee Inc 24 BLISTER PACK in 1 CARTON (42507-224-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK March 21, 2003
42507-224-91 42507-224 HyVee Inc 6 BLISTER PACK in 1 CARTON (42507-224-91) / 1 TABLET, FILM COATED in 1 BLISTER PACK March 21, 2003
0113-2224-62 0113-2224 L. Perrigo Company 24 BLISTER PACK in 1 CARTON (0113-2224-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK December 17, 2019
0113-2224-68 0113-2224 L. Perrigo Company 36 BLISTER PACK in 1 CARTON (0113-2224-68) / 1 TABLET, FILM COATED in 1 BLISTER PACK June 25, 2018
0904-7725-12 0904-7725 Major Pharmaceuticals 12 BLISTER PACK in 1 CARTON (0904-7725-12) / 1 TABLET, FILM COATED in 1 BLISTER PACK February 24, 2003
0904-7725-24 0904-7725 Major Pharmaceuticals 24 BLISTER PACK in 1 CARTON (0904-7725-24) / 1 TABLET, FILM COATED in 1 BLISTER PACK February 24, 2003
41250-224-53 41250-224 Meijer Distribution Inc 12 BLISTER PACK in 1 CARTON (41250-224-53) / 1 TABLET, FILM COATED in 1 BLISTER PACK March 24, 2003
41250-224-62 41250-224 Meijer Distribution Inc 24 BLISTER PACK in 1 CARTON (41250-224-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK June 19, 2024
41250-224-91 41250-224 Meijer Distribution Inc 6 BLISTER PACK in 1 CARTON (41250-224-91) / 1 TABLET, FILM COATED in 1 BLISTER PACK March 16, 2016
56062-224-53 56062-224 Publix Super Markets Inc 12 BLISTER PACK in 1 CARTON (56062-224-53) / 1 TABLET, FILM COATED in 1 BLISTER PACK March 19, 2003
56062-224-62 56062-224 Publix Super Markets Inc 24 BLISTER PACK in 1 CARTON (56062-224-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK March 25, 2003
67296-1472-7 67296-1472 Redpharm Drug Inc 24 TABLET, FILM COATED in 1 BOTTLE (67296-1472-7) February 24, 2003
0363-1010-53 0363-1010 Walgreen Company 12 BLISTER PACK in 1 CARTON (0363-1010-53) / 1 TABLET, FILM COATED in 1 BLISTER PACK September 11, 2021
0363-1010-62 0363-1010 Walgreen Company 24 BLISTER PACK in 1 CARTON (0363-1010-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK September 14, 2021
0363-1010-91 0363-1010 Walgreen Company 6 BLISTER PACK in 1 CARTON (0363-1010-91) / 1 TABLET, FILM COATED in 1 BLISTER PACK September 14, 2021
59779-700 59779-700 CVS Pharmacy — February 24, 2003
59779-960 59779-960 CVS Pharmacy — April 21, 2003
37808-552 37808-552 H E B — May 1, 2014
42507-224 42507-224 HyVee Inc — March 21, 2003
0113-2224 0113-2224 L. Perrigo Company — June 25, 2018
0904-7725 0904-7725 Major Pharmaceuticals — February 24, 2003
41250-224 41250-224 Meijer Distribution Inc — March 5, 2003
56062-224 56062-224 Publix Super Markets Inc — March 19, 2003
67296-1472 67296-1472 Redpharm Drug Inc — February 24, 2003
0363-1010 0363-1010 Walgreen Company — September 11, 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 · 11 sections on this page.