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Anti-Diarrheal

Loperamide HCl · Tablet

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 HCl
Dosage form
Tablet
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Advanced Rx LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
24
Packages
43
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
Bismuth Subsalicylate 262 mg/1 308762 —
Loperamide Hydrochloride 2 mg/1 978006 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet
Route of administration
Oral
Presentations
67

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
076497
Application type
ANDA · Abbreviated New Drug Application
Approval date
June 10, 2003
Sponsor
LNK
Products on application
1
Submissions recorded
3
Products approved under application 076497.
Product Trade name Form Strength Ingredient Status TE Flags
076497-001 LOPERAMIDE HYDROCHLORIDE TABLET LOPERAMIDE HYDROCHLORIDE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 076497.
Type No. Action Status Date Review
Supplement 7 Labeling Approved April 2, 2021 Standard
Supplement 2 Labeling Approved September 9, 2015 —
Original application 1 Approved June 10, 2003 —

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20241229). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20241229 HUMAN OTC DRUG · 20241125

Indications and Usage

openFDA Drug Labeling

Uses relieves: indigestion nausea heartburn diarrhea upset stomach associated with these symptoms

Purpose Upset stomach reliever and 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 hour 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 - 47 lbs) ask a doctor children under 2 (up to 33 lbs) do not use

Warnings Reye's syndrome Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert Contains salicylate. Do not take if you are allergic to salicylates (including aspirin) taking other salicylate products Do not use if you have bloody or black stool an ulcer a bleeding problem Ask a doctor before use if you have fever mucus in the stool Ask a doctor or pharmacist before use if you are taking any drug for anticoagulation (thinning of the blood) diabetes gout arthritis When using this product a temporary, but harmless darkening of the stool and/or tongue may occur. Stop use and ask a doctor if symptoms get worse ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days 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 immediately.

Do not use if you have bloody or black stool an ulcer a bleeding problem

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 caplet) Bismuth subsalicylate 262 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
80513-375-08 80513-375 Advanced Rx LLC 4 BLISTER PACK in 1 CARTON (80513-375-08) / 6 TABLET in 1 BLISTER PACK January 3, 2025
80513-401-24 80513-401 Advanced Rx LLC 4 BLISTER PACK in 1 CARTON (80513-401-24) / 6 TABLET in 1 BLISTER PACK August 11, 2024
37835-131-01 37835-131 BI-MART 100 TABLET in 1 BOTTLE (37835-131-01) May 1, 2025
37835-131-12 37835-131 BI-MART 2 BLISTER PACK in 1 CARTON (37835-131-12) / 6 TABLET in 1 BLISTER PACK May 1, 2025
37835-131-24 37835-131 BI-MART 4 BLISTER PACK in 1 CARTON (37835-131-24) / 6 TABLET in 1 BLISTER PACK May 1, 2025
21130-375-08 21130-375 Better Living Brands, LLC 4 BLISTER PACK in 1 CARTON (21130-375-08) / 6 TABLET in 1 BLISTER PACK May 3, 2005
68016-301-18 68016-301 Chain Drug Consortium 3 BLISTER PACK in 1 CARTON (68016-301-18) / 6 TABLET in 1 BLISTER PACK December 6, 2019
68016-301-24 68016-301 Chain Drug Consortium 4 BLISTER PACK in 1 CARTON (68016-301-24) / 6 TABLET in 1 BLISTER PACK December 6, 2019
55910-375-02 55910-375 DOLGENCORP, LLC 2 BLISTER PACK in 1 CARTON (55910-375-02) / 6 TABLET in 1 BLISTER PACK January 12, 2024
55910-375-08 55910-375 DOLGENCORP, LLC 4 BLISTER PACK in 1 CARTON (55910-375-08) / 6 TABLET in 1 BLISTER PACK January 12, 2024
53943-375-02 53943-375 Discount Drug Mart 2 BLISTER PACK in 1 CARTON (53943-375-02) / 6 TABLET in 1 BLISTER PACK December 13, 2019
53943-375-08 53943-375 Discount Drug Mart 4 BLISTER PACK in 1 CARTON (53943-375-08) / 6 TABLET in 1 BLISTER PACK December 13, 2019
55319-375-08 55319-375 Family Dollar Services Inc 4 BLISTER PACK in 1 CARTON (55319-375-08) / 6 TABLET in 1 BLISTER PACK May 3, 2005
55319-375-12 55319-375 Family Dollar Services Inc 2 BLISTER PACK in 1 CARTON (55319-375-12) / 6 TABLET in 1 BLISTER PACK May 3, 2005
57896-381-13 57896-381 Geri-Care Pharmaceutical Corp 2 BLISTER PACK in 1 CARTON (57896-381-13) / 6 TABLET in 1 BLISTER PACK March 1, 2021
57896-381-25 57896-381 Geri-Care Pharmaceutical Corp 4 BLISTER PACK in 1 CARTON (57896-381-25) / 6 TABLET in 1 BLISTER PACK September 1, 2020
37808-375-08 37808-375 H E B 4 BLISTER PACK in 1 CARTON (37808-375-08) / 6 TABLET in 1 BLISTER PACK May 3, 2005
80136-063-11 80136-063 Heartland Pharma Co. 4 BLISTER PACK in 1 CARTON (80136-063-11) / 6 TABLET in 1 BLISTER PACK January 22, 2021
84441-711-02 84441-711 IMO-GEN LABS LLC 200 TABLET in 1 BOTTLE (84441-711-02) January 1, 2024
84441-711-25 84441-711 IMO-GEN LABS LLC 250 TABLET in 1 BOTTLE (84441-711-25) February 4, 2026
84441-711-96 84441-711 IMO-GEN LABS LLC 96 TABLET in 1 BOTTLE (84441-711-96) January 1, 2024
30142-775-02 30142-775 Kroger Company 2 BLISTER PACK in 1 CARTON (30142-775-02) / 6 TABLET in 1 BLISTER PACK May 6, 2020
30142-775-08 30142-775 Kroger Company 4 BLISTER PACK in 1 CARTON (30142-775-08) / 6 TABLET in 1 BLISTER PACK May 6, 2020
50844-259-02 50844-259 L.N.K. International, Inc. 2 BLISTER PACK in 1 CARTON (50844-259-02) / 6 TABLET in 1 BLISTER PACK July 15, 2019
50844-375-02 50844-375 L.N.K. International, Inc. 3 BLISTER PACK in 1 CARTON (50844-375-02) / 4 TABLET in 1 BLISTER PACK May 3, 2005
50844-375-08 50844-375 L.N.K. International, Inc. 4 BLISTER PACK in 1 CARTON (50844-375-08) / 6 TABLET in 1 BLISTER PACK May 3, 2005
50844-375-45 50844-375 L.N.K. International, Inc. 1 BLISTER PACK in 1 CARTON (50844-375-45) / 6 TABLET in 1 BLISTER PACK May 3, 2005
50844-375-95 50844-375 L.N.K. International, Inc. 2 BLISTER PACK in 1 CARTON (50844-375-95) / 6 TABLET in 1 BLISTER PACK May 3, 2005
29485-9286-2 29485-9286 Lil' Drug Store Products, Inc. 25 POUCH in 1 BOX (29485-9286-2) / 1 TABLET in 1 POUCH July 27, 2016
29485-9286-3 29485-9286 Lil' Drug Store Products, Inc. 30 POUCH in 1 BOX (29485-9286-3) / 1 TABLET in 1 POUCH July 27, 2016
66715-6841-4 66715-6841 Lil' Drug Store Products, Inc. 1 BOTTLE, PLASTIC in 1 CARTON (66715-6841-4) / 24 TABLET in 1 BOTTLE, PLASTIC February 21, 2019
67296-2314-2 67296-2314 Redpharm Drug 4 BLISTER PACK in 1 CARTON (67296-2314-2) / 6 TABLET in 1 BLISTER PACK September 1, 2020
11822-0375-3 11822-0375 Rite Aid Corporation 2 BLISTER PACK in 1 CARTON (11822-0375-3) / 6 TABLET in 1 BLISTER PACK May 3, 2005
11822-0375-8 11822-0375 Rite Aid Corporation 4 BLISTER PACK in 1 CARTON (11822-0375-8) / 6 TABLET in 1 BLISTER PACK May 3, 2005
66424-725-24 66424-725 SDA Laboratories, Inc. 4 BLISTER PACK in 1 CARTON (66424-725-24) / 6 TABLET in 1 BLISTER PACK February 1, 2024
41163-375-02 41163-375 United Natural Foods, Inc. dba UNFI 2 BLISTER PACK in 1 CARTON (41163-375-02) / 6 TABLET in 1 BLISTER PACK May 3, 2005
41163-375-08 41163-375 United Natural Foods, Inc. dba UNFI 4 BLISTER PACK in 1 CARTON (41163-375-08) / 6 TABLET in 1 BLISTER PACK May 3, 2005
63941-375-02 63941-375 Valu Merchandisers Company 2 BLISTER PACK in 1 CARTON (63941-375-02) / 6 TABLET in 1 BLISTER PACK May 5, 2020
63941-375-08 63941-375 Valu Merchandisers Company 4 BLISTER PACK in 1 CARTON (63941-375-08) / 6 TABLET in 1 BLISTER PACK May 5, 2020
0363-0375-02 0363-0375 Walgreen Company 2 BLISTER PACK in 1 CARTON (0363-0375-02) / 6 TABLET in 1 BLISTER PACK May 3, 2005
0363-0375-08 0363-0375 Walgreen Company 4 BLISTER PACK in 1 CARTON (0363-0375-08) / 6 TABLET in 1 BLISTER PACK May 3, 2005
0363-0375-45 0363-0375 Walgreen Company 1 BLISTER PACK in 1 CARTON (0363-0375-45) / 6 TABLET in 1 BLISTER PACK May 3, 2005
67091-335-18 67091-335 WinCo Foods, LLC 2 BLISTER PACK in 1 CARTON (67091-335-18) / 6 TABLET in 1 BLISTER PACK February 8, 2019
80513-375 80513-375 Advanced Rx LLC — January 3, 2025
80513-401 80513-401 Advanced Rx LLC — January 1, 2024
37835-131 37835-131 BI-MART — May 1, 2025
21130-375 21130-375 Better Living Brands, LLC — May 3, 2005
68016-301 68016-301 Chain Drug Consortium — December 6, 2019
55910-375 55910-375 DOLGENCORP, LLC — January 12, 2024
53943-375 53943-375 Discount Drug Mart — December 13, 2019
55319-375 55319-375 Family Dollar Services Inc — May 3, 2005
57896-381 57896-381 Geri-Care Pharmaceutical Corp — January 1, 2006
37808-375 37808-375 H E B — May 3, 2005
80136-063 80136-063 Heartland Pharma Co. — January 22, 2021
84441-711 84441-711 IMO-GEN LABS LLC — January 1, 2024
30142-775 30142-775 Kroger Company — May 6, 2020
50844-259 50844-259 L.N.K. International, Inc. — July 15, 2019
50844-375 50844-375 L.N.K. International, Inc. — May 3, 2005
29485-9286 29485-9286 Lil' Drug Store Products, Inc. — July 27, 2016
66715-6841 66715-6841 Lil' Drug Store Products, Inc. — February 21, 2019
67296-2314 67296-2314 Redpharm Drug — January 1, 2006
11822-0375 11822-0375 Rite Aid Corporation — May 3, 2005
66424-725 66424-725 SDA Laboratories, Inc. — February 1, 2024
41163-375 41163-375 United Natural Foods, Inc. dba UNFI — May 3, 2005
63941-375 63941-375 Valu Merchandisers Company — May 5, 2020
0363-0375 0363-0375 Walgreen Company — May 3, 2005
67091-335 67091-335 WinCo Foods, LLC — February 8, 2019

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.