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Loperamide Hydrochloride

loperamide HCl · Solution

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 HCl
Dosage form
Solution
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Precision Dose, Inc.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
12
Packages
16
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 1 mg/7.5mL 978006 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Solution
Route of administration
Oral
Presentations
28

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
091292
Application type
ANDA · Abbreviated New Drug Application
Approval date
May 20, 2011
Sponsor
PERRIGO R AND D
Products on application
1
Submissions recorded
5
Products approved under application 091292.
Product Trade name Form Strength Ingredient Status TE Flags
091292-001 LOPERAMIDE HYDROCHLORIDE SOLUTION LOPERAMIDE HYDROCHLORIDE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 091292.
Type No. Action Status Date Review
Supplement 16 Labeling Approved December 13, 2021 Standard
Supplement 12 Labeling Approved December 13, 2021 Standard
Supplement 8 Labeling Approved November 30, 2015 Standard
Supplement 3 Labeling Approved November 30, 2015 Standard
Original application 1 Approved May 20, 2011 —

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260630). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260630 HUMAN OTC DRUG · 20260227 HUMAN OTC DRUG · 20260213 HUMAN OTC DRUG · 20250627

Indications and Usage

openFDA Drug Labeling

Use controls symptoms of diarrhea, including Travelers' Diarrhea Read complete directions and warnings before using.

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. shake well before using use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device. mL = milliliter adults and children 12 years and over 30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hours children 9 years to 11 years (60 lbs to 95 lbs) 15 mL after first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours children 6 years to 8 years (48 lbs to 59 lbs) 15 mL after first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL in 24 hours children 2 years to 5 years (34 lbs to 47 lbs) ask a doctor children under 2 years (up to 33 lbs) do not use

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 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 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 7.5 mL) Loperamide HCl, USP 1 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
17856-6836-1 17856-6836 ATLANTIC BIOLOGICALS CORP. 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-6836-1) / 7.5 mL in 1 CUP, UNIT-DOSE (17856-6836-3) April 22, 2024
17856-6836-2 17856-6836 ATLANTIC BIOLOGICALS CORP. 50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-6836-2) / 15 mL in 1 CUP, UNIT-DOSE (17856-6836-4) April 22, 2024
72288-048-34 72288-048 Amazon.com Services LLC 240 mL in 1 BOTTLE (72288-048-34) July 30, 2026
69452-405-55 69452-405 Bionpharma Inc. 120 mL in 1 BOTTLE (69452-405-55) March 2, 2026
69452-405-93 69452-405 Bionpharma Inc. 240 mL in 1 BOTTLE (69452-405-93) March 3, 2026
69842-191-26 69842-191 CVS Pharmacy 120 mL in 1 BOTTLE (69842-191-26) June 28, 2018
69842-191-34 69842-191 CVS Pharmacy 237 mL in 1 BOTTLE (69842-191-34) June 28, 2018
55910-155-55 55910-155 DOLGENCORP INC 120 mL in 1 BOTTLE (55910-155-55) March 30, 2026
81033-067-34 81033-067 Kesin Pharma Corporation 30 CUP, UNIT-DOSE in 1 CARTON (81033-067-34) / 7.5 mL in 1 CUP, UNIT-DOSE (81033-067-07) June 30, 2026
81033-067-35 81033-067 Kesin Pharma Corporation 30 CUP, UNIT-DOSE in 1 CARTON (81033-067-35) / 15 mL in 1 CUP, UNIT-DOSE (81033-067-15) June 30, 2026
0904-6836-20 0904-6836 Major Pharmaceuticals 120 mL in 1 BOTTLE (0904-6836-20) November 29, 2018
41250-813-26 41250-813 Meijer Distribution Inc 120 mL in 1 BOTTLE (41250-813-26) July 10, 2018
68094-029-62 68094-029 Precision Dose, Inc. 3 TRAY in 1 CASE (68094-029-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 7.5 mL in 1 CUP, UNIT-DOSE (68094-029-59) May 18, 2020
68094-129-62 68094-129 Precision Dose, Inc. 3 TRAY in 1 CASE (68094-129-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (68094-129-59) May 18, 2020
68788-7842-1 68788-7842 Preferred Pharmaceuticals Inc. 120 mL in 1 BOTTLE (68788-7842-1) January 19, 2021
11822-5519-2 11822-5519 Rite Aid Corporation 240 mL in 1 BOTTLE (11822-5519-2) June 18, 2018
17856-6836 17856-6836 ATLANTIC BIOLOGICALS CORP. — November 29, 2018
72288-048 72288-048 Amazon.com Services LLC — July 30, 2026
69452-405 69452-405 BIONPHARMA INC. — February 27, 2026
69842-191 69842-191 CVS Pharmacy — June 28, 2018
55910-155 55910-155 DOLGENCORP INC — March 30, 2026
81033-067 81033-067 Kesin Pharma Corporation — November 13, 2024
0904-6836 0904-6836 Major Pharmaceuticals — November 29, 2018
41250-813 41250-813 Meijer Distribution Inc — July 10, 2018
68094-029 68094-029 Precision Dose, Inc. — May 18, 2020
68094-129 68094-129 Precision Dose, Inc. — May 18, 2020
68788-7842 68788-7842 Preferred Pharmaceuticals Inc. — January 19, 2021
11822-5519 11822-5519 Rite Aid Corporation — June 18, 2018

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.