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Loperamide Hydrochloride

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
Loperamide Hydrochloride
Generic name
Loperamide Hydrochloride
Dosage form
Capsule, Liquid Filled
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Dr. Reddy's Laboratories Inc.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
6
Packages
13
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
Capsule, Liquid Filled
Route of administration
Oral
Presentations
19

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
213070
Application type
ANDA · Abbreviated New Drug Application
Approval date
August 11, 2021
Sponsor
ONESOURCE
Products on application
1
Submissions recorded
1
Products approved under application 213070.
Product Trade name Form Strength Ingredient Status TE Flags
213070-001 LOPERAMIDE HYDROCHLORIDE CAPSULE LOPERAMIDE HYDROCHLORIDE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 213070.
Type No. Action Status Date Review
Original application 1 Approved August 11, 2021 Standard

Review documents

  • 0 · Original application · September 2, 2021

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260909). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260909 HUMAN OTC DRUG · 20230625

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. not for use in children under 12 years of age adults and children 12 years and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours

Warnings

openFDA Drug Labeling

Warnings Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide hydrochloride Heart alert: Taking more than directed can cause serious heart problems or death

Do Not Use

openFDA Drug Labeling

Do not use if you have bloody or black stool in children under 12 years of age

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 capsule) Loperamide Hydrochloride USP, 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
59651-994-36 59651-994 Aurobindo Pharma Limited 5000 CAPSULE, LIQUID FILLED in 1 BAG (59651-994-36) December 29, 2025
58602-727-74 58602-727 Aurohealth LLC 1 BLISTER PACK in 1 CARTON (58602-727-74) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK December 29, 2025
58602-727-75 58602-727 Aurohealth LLC 2 BLISTER PACK in 1 CARTON (58602-727-75) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK December 29, 2025
58602-727-76 58602-727 Aurohealth LLC 4 BLISTER PACK in 1 CARTON (58602-727-76) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK December 29, 2025
58602-727-77 58602-727 Aurohealth LLC 1 BLISTER PACK in 1 CARTON (58602-727-77) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK August 28, 2026
58602-727-78 58602-727 Aurohealth LLC 2 BLISTER PACK in 1 CARTON (58602-727-78) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK August 28, 2026
58602-727-80 58602-727 Aurohealth LLC 3 BLISTER PACK in 1 CARTON (58602-727-80) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK December 29, 2025
43598-770-24 43598-770 Dr. Reddy's Laboratories Inc. 2 BLISTER PACK in 1 CARTON (43598-770-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK August 1, 2023
75907-097-12 75907-097 Dr. Reddy's Laboratories Inc. 1 BLISTER PACK in 1 CARTON (75907-097-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK August 1, 2023
75907-097-24 75907-097 Dr. Reddy's Laboratories Inc. 2 BLISTER PACK in 1 CARTON (75907-097-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK August 1, 2023
59556-959-05 59556-959 Strides Pharma, Inc. 2 BLISTER PACK in 1 CARTON (59556-959-05) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (59556-959-03) October 22, 2021
59556-959-06 59556-959 Strides Pharma, Inc. 1 BLISTER PACK in 1 CARTON (59556-959-06) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (59556-959-03) October 22, 2021
73581-177-02 73581-177 YYBA CORP 2 BLISTER PACK in 1 CARTON (73581-177-02) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK September 1, 2026
59651-994 59651-994 Aurobindo Pharma Limited — December 29, 2025
58602-727 58602-727 Aurohealth LLC — December 29, 2025
43598-770 43598-770 Dr. Reddy's Laboratories Inc. — October 22, 2021
75907-097 75907-097 Dr. Reddy's Laboratories Inc. — October 22, 2021
59556-959 59556-959 Strides Pharma, Inc. — October 22, 2021
73581-177 73581-177 YYBA CORP — September 1, 2026

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.