Loperamide Hydrochloride — Tablet

Overview

Brand name

Loperamide Hydrochloride

Generic name

Loperamide Hydrochloride

Dosage form

Tablet

Route

Oral

Marketing category

ANDA · ANDA

Labeler

Aurohealth LLC

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

1

NDC product codes

18

Packages

32

Data completeness

83% 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

Route of administration

Oral

Presentations

50

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

074091

Application type

ANDA · Abbreviated New Drug Application

Approval date

December 10, 1992

Sponsor

OHM LABS

Products on application

1

Submissions recorded

14

Products approved under application 074091.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
074091-001	LOPERAMIDE HYDROCHLORIDE	TABLET		LOPERAMIDE HYDROCHLORIDE	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 074091.
Type	No.	Action	Status	Date	Review
Supplement	34	Labeling	Approved	July 9, 2021	Standard
Supplement	33	Labeling	Approved	July 9, 2021	Standard
Supplement	30	Labeling	Approved	July 9, 2021	Standard
Supplement	36	Labeling	Approved	September 9, 2020	Standard
Supplement	21	Labeling	Approved	September 12, 2006	—
Supplement	9	Labeling	Approved	October 16, 2002	—
Supplement	8	Manufacturing (CMC)	Approved	January 17, 2002	—
Supplement	5	Labeling	Approved	December 28, 2000	—
Supplement	7	Manufacturing (CMC)	Approved	June 21, 2000	—
Supplement	3	Labeling	Approved	February 27, 1998	—
Supplement	4	Manufacturing (CMC)	Approved	May 13, 1997	—
Supplement	2	Manufacturing (CMC)	Approved	July 18, 1994	—
Supplement	1	Labeling	Approved	June 16, 1993	—
Original application	1		Approved	December 10, 1992	—

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260528). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260528 HUMAN OTC DRUG · 20250122 HUMAN OTC DRUG · 20241229 HUMAN OTC DRUG · 20240111

Indications and Usage

openFDA Drug Labeling

USE(S) 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 tablets after the first loose stool; 1 tablet after each subsequent loose stool; but no more than 4 tablets in 24 hours children 9 to 11 years (60 to 95 lbs) 1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 3 tablets in 24 hours children 6 to 8 years (48 to 59 lbs) 1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 2 tablets in 24 hours children 2 to 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 hydrochloride 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

Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs.

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

Drug Facts Active ingredient (in each tablet) 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.

Recalls

Source: FDA Enforcement

Drug recall enforcement reports associated with this product.
Classification	Reported	Firm	Reason	Status
Class III	January 30, 2019	Sun Pharmaceutical Industries, Inc.	Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets.	Terminated

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
46122-738-53	46122-738	Amerisource Bergen	2 BLISTER PACK in 1 CARTON (46122-738-53) / 6 TABLET in 1 BLISTER PACK	July 5, 2023
46122-738-62	46122-738	Amerisource Bergen	4 BLISTER PACK in 1 CARTON (46122-738-62) / 6 TABLET in 1 BLISTER PACK	July 20, 2023
59651-022-49	59651-022	Aurobindo Pharma Limited	4000 TABLET in 1 BAG (59651-022-49)	December 15, 2015
84386-117-24	84386-117	Aurobindo Pharma Limited	4 BLISTER PACK in 1 CARTON (84386-117-24) / 6 TABLET in 1 BLISTER PACK	June 3, 2026
58602-701-01	58602-701	Aurohealth LLC	1 BLISTER PACK in 1 CARTON (58602-701-01) / 6 TABLET in 1 BLISTER PACK	December 15, 2015
58602-701-02	58602-701	Aurohealth LLC	2 BLISTER PACK in 1 CARTON (58602-701-02) / 6 TABLET in 1 BLISTER PACK	December 15, 2015
58602-701-76	58602-701	Aurohealth LLC	4 BLISTER PACK in 1 CARTON (58602-701-76) / 6 TABLET in 1 BLISTER PACK	December 15, 2015
58602-870-76	58602-870	Aurohealth LLC	4 BLISTER PACK in 1 CARTON (58602-870-76) / 6 TABLET in 1 BLISTER PACK	March 22, 2022
68016-123-06	68016-123	Chain Drug Consortium, LLC	6 TABLET in 1 BLISTER PACK (68016-123-06)	February 1, 1993
68016-123-18	68016-123	Chain Drug Consortium, LLC	18 TABLET in 1 BLISTER PACK (68016-123-18)	February 1, 1993
68016-123-24	68016-123	Chain Drug Consortium, LLC	24 TABLET in 1 BLISTER PACK (68016-123-24)	February 1, 1993
68016-123-97	68016-123	Chain Drug Consortium, LLC	96 TABLET in 1 BOTTLE (68016-123-97)	February 1, 1993
63868-338-12	63868-338	Chain Drug Marketing Association Inc.	12 TABLET in 1 BLISTER PACK (63868-338-12)	February 1, 1993
63868-338-24	63868-338	Chain Drug Marketing Association Inc.	24 TABLET in 1 BLISTER PACK (63868-338-24)	February 1, 1993
63868-338-60	63868-338	Chain Drug Marketing Association Inc.	60 TABLET in 1 BOTTLE (63868-338-60)	February 1, 1993
53943-123-12	53943-123	Discount Drug Mart	12 TABLET in 1 BLISTER PACK (53943-123-12)	February 1, 1993
53943-123-24	53943-123	Discount Drug Mart	24 TABLET in 1 BLISTER PACK (53943-123-24)	February 1, 1993
55315-123-06	55315-123	Fred's Inc.	6 TABLET in 1 BLISTER PACK (55315-123-06)	February 1, 1993
55315-123-24	55315-123	Fred's Inc.	24 TABLET in 1 BLISTER PACK (55315-123-24)	February 1, 1993
68998-123-24	68998-123	Marc Glassman, Inc.	4 BLISTER PACK in 1 CARTON (68998-123-24) / 6 TABLET in 1 BLISTER PACK	May 1, 2018
53329-664-57	53329-664	Medline Industries, LP	12 TABLET in 1 BLISTER PACK (53329-664-57)	February 1, 1993
51660-123-06	51660-123	Ohm Laboratories Inc.	1 BLISTER PACK in 1 CARTON (51660-123-06) / 6 TABLET in 1 BLISTER PACK	February 1, 1993
51660-123-12	51660-123	Ohm Laboratories Inc.	2 BLISTER PACK in 1 CARTON (51660-123-12) / 6 TABLET in 1 BLISTER PACK	February 1, 1993
51660-123-24	51660-123	Ohm Laboratories Inc.	4 BLISTER PACK in 1 CARTON (51660-123-24) / 6 TABLET in 1 BLISTER PACK	February 1, 1993
68788-8393-2	68788-8393	Preferred Pharmaceuticals Inc.	4 BLISTER PACK in 1 CARTON (68788-8393-2) / 6 TABLET in 1 BLISTER PACK	March 1, 2023
63187-462-12	63187-462	Proficient Rx LP	12 TABLET in 1 BLISTER PACK (63187-462-12)	March 27, 2014
85766-154-06	85766-154	Sportpharm LLC	1 BLISTER PACK in 1 CARTON (85766-154-06) / 6 TABLET in 1 BLISTER PACK	February 6, 2026
85766-154-12	85766-154	Sportpharm LLC	2 BLISTER PACK in 1 CARTON (85766-154-12) / 6 TABLET in 1 BLISTER PACK	June 27, 2026
63941-123-12	63941-123	Valu Merchandisers Company	12 TABLET in 1 BLISTER PACK (63941-123-12)	February 1, 1993
63941-123-24	63941-123	Valu Merchandisers Company	24 TABLET in 1 BLISTER PACK (63941-123-24)	February 1, 1993
73581-175-24	73581-175	YYBA CORP	4 BLISTER PACK in 1 CARTON (73581-175-24) / 6 TABLET in 1 BLISTER PACK	July 13, 2026
35418-123-12	35418-123	Zee Medical Inc	2 BLISTER PACK in 1 CARTON (35418-123-12) / 6 TABLET in 1 BLISTER PACK	January 16, 2014
46122-738	46122-738	Amerisource Bergen	—	July 5, 2023
59651-022	59651-022	Aurobindo Pharma Limited	—	December 15, 2015
84386-117	84386-117	Aurobindo Pharma Limited	—	June 3, 2026
58602-701	58602-701	Aurohealth LLC	—	December 15, 2015
58602-870	58602-870	Aurohealth LLC	—	March 22, 2022
68016-123	68016-123	Chain Drug Consortium, LLC	—	February 1, 1993
63868-338	63868-338	Chain Drug Marketing Association Inc.	—	February 1, 1993
53943-123	53943-123	Discount Drug Mart	—	February 1, 1993
55315-123	55315-123	Fred's Inc.	—	February 1, 1993
68998-123	68998-123	Marc Glassman, Inc.	—	May 1, 2018
53329-664	53329-664	Medline Industries, LP	—	February 1, 1993
51660-123	51660-123	Ohm Laboratories Inc.	—	February 1, 1993
68788-8393	68788-8393	Preferred Pharmaceuticals Inc.	—	March 1, 2023
63187-462	63187-462	Proficient Rx LP	—	February 1, 1993
85766-154	85766-154	Sportpharm LLC	—	February 6, 2026
63941-123	63941-123	Valu Merchandisers Company	—	February 1, 1993
73581-175	73581-175	YYBA CORP	—	July 13, 2026
35418-123	35418-123	Zee Medical Inc	—	January 16, 2014

Related products

same generic name, other forms

Loperamide Hydrochloride Capsule Loperamide Hydrochloride Solution Loperamide Hydrochloride Capsule, Liquid Filled

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
Enforcement	FDA	Recall records

Generated September 25, 2026 · 12 sections on this page.