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Anti-Diarrheal
Loperamide Hydrochloride · Capsule, Liquid Filled
Over-the-counter NDA RLD 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
Capsule, Liquid Filled
Route
Oral
Marketing category
NDA · NDA
Labeler
CHAIN DRUG MARKETING ASSOCIATION INC.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
26
Packages
33
Data completeness
82%
of corroborating sources present
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Loperamide Hydrochloride | 2 mg/1 | 978006 | View |
Forms, strengths and routes
Source: NDC DirectoryDosage form
Capsule, Liquid Filled
Route of administration
Oral
Presentations
59
Pharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Opioid Agonist [EPC] | EPC | All 109 members |
| Opioid Agonists [MoA] | MoA | All 35 members |
Regulatory status
Source: Drugs@FDANDC DirectoryApplication number
021855
Application type
NDA · New Drug Application
Approval date
August 4, 2005
Sponsor
BIONPHARMA
Products on application
2
Submissions recorded
5
| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 021855-001 | LOPERAMIDE HYDROCHLORIDE | CAPSULE | LOPERAMIDE HYDROCHLORIDE | Over-the-counter | — | RLD | |
| 021855-002 | LOPERAMIDE HYDROCHLORIDE | CAPSULE | LOPERAMIDE HYDROCHLORIDE | Over-the-counter | — | RLD RS |
Therapeutic equivalence
Source: Orange BookTE code
—
Reference Listed Drug
Yes
Reference Standard
Yes
Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 14 | Labeling | Approved | June 22, 2020 | Standard |
| Supplement | 9 | Manufacturing (CMC) | Approved | January 31, 2019 | N/A |
| Supplement | 6 | Labeling | Approved | March 9, 2017 | Standard |
| Supplement | 5 | Manufacturing (CMC) | Approved | December 11, 2015 | Standard |
| Original application | 1 | Type 3 - New Dosage Form | Approved | August 4, 2005 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20231226). This is the manufacturer's labelling text, not a summary and not advice.
HUMAN OTC DRUG · 20231226 HUMAN OTC DRUG · 20221230
Indications and Usage
openFDA Drug LabelingUse controls symptoms of diarrhea, including Travelers' Diarrhea
Purpose
openFDA Drug LabelingPurpose Anti-diarrheal
Dosage and Administration
openFDA Drug LabelingDirections 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 capsules after the first loose stool; 1 capsules after each subsequent loose stool; but no more than 4 capsules in 24 hours
Warnings
openFDA Drug LabelingWarnings 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
openFDA Drug LabelingDo not use if you have bloody or black stool in children under 12 years of age
Ask a Doctor
openFDA Drug LabelingAsk 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 LabelingStop 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 LabelingActive ingredient (in each capsule) Loperamide HCI 2 mg
Adverse event reports
Source: openFDA FAERS50,038
FAERS reports mentioning this drug
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| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 46122-581-62 | 46122-581 | AMERISOURCE BERGEN | 2 BLISTER PACK in 1 CARTON (46122-581-62) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | February 15, 2019 |
| 21130-835-12 | 21130-835 | Albertsons Companies | 2 BLISTER PACK in 1 CARTON (21130-835-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | April 7, 2025 |
| 72288-313-12 | 72288-313 | Amazon.com Services LLC | 2 BLISTER PACK in 1 CARTON (72288-313-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | February 12, 2024 |
| 69452-176-12 | 69452-176 | Bionpharma Inc. | 1 BLISTER PACK in 1 CARTON (69452-176-12) / 24 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | August 2, 2019 |
| 69452-266-12 | 69452-266 | Bionpharma Inc. | 2 BLISTER PACK in 1 CARTON (69452-266-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | March 20, 2020 |
| 70000-0461-1 | 70000-0461 | CARDINAL HEALTH | 2 BLISTER PACK in 1 CARTON (70000-0461-1) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | January 21, 2019 |
| 63868-876-12 | 63868-876 | CHAIN DRUG MARKETING ASSOCIATION INC. | 1 BLISTER PACK in 1 CARTON (63868-876-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | January 25, 2019 |
| 63868-876-24 | 63868-876 | CHAIN DRUG MARKETING ASSOCIATION INC. | 2 BLISTER PACK in 1 CARTON (63868-876-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | January 25, 2019 |
| 83324-208-12 | 83324-208 | CHAIN DRUG MARKETING ASSOCIATION INC. | 1 BLISTER PACK in 1 CARTON (83324-208-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | May 21, 2025 |
| 83324-209-24 | 83324-209 | CHAIN DRUG MARKETING ASSOCIATION INC. | 2 BLISTER PACK in 1 CARTON (83324-209-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | May 21, 2025 |
| 69842-061-08 | 69842-061 | CVS Pharmacy, Inc. | 1 BLISTER PACK in 1 CARTON (69842-061-08) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | February 27, 2026 |
| 69842-061-12 | 69842-061 | CVS Pharmacy, Inc. | 2 BLISTER PACK in 1 CARTON (69842-061-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | December 4, 2018 |
| 53943-176-12 | 53943-176 | DISCOUNT DRUG MART, INC. | 2 BLISTER PACK in 1 CARTON (53943-176-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | November 1, 2018 |
| 55910-176-08 | 55910-176 | DOLGENCORP, LLC | 1 BLISTER PACK in 1 CARTON (55910-176-08) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | June 3, 2022 |
| 55910-176-12 | 55910-176 | DOLGENCORP, LLC | 2 BLISTER PACK in 1 CARTON (55910-176-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | August 17, 2018 |
| 37808-988-12 | 37808-988 | HEB | 2 BLISTER PACK in 1 CARTON (37808-988-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | December 4, 2018 |
| 30142-159-08 | 30142-159 | KROGER COMPANY | 1 BLISTER PACK in 1 CARTON (30142-159-08) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | March 1, 2019 |
| 30142-159-12 | 30142-159 | KROGER COMPANY | 2 BLISTER PACK in 1 CARTON (30142-159-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | March 1, 2019 |
| 41250-210-08 | 41250-210 | MEIJER DISTRIBUTION INC | 1 BLISTER PACK in 1 CARTON (41250-210-08) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | January 13, 2020 |
| 41250-210-12 | 41250-210 | MEIJER DISTRIBUTION INC | 2 BLISTER PACK in 1 CARTON (41250-210-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | February 1, 2019 |
| 80136-851-42 | 80136-851 | Northeast Pharma | 2 BLISTER PACK in 1 CARTON (80136-851-42) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | May 21, 2021 |
| 56062-680-12 | 56062-680 | PUBLIX SUPER MARKETS INC | 2 BLISTER PACK in 1 CARTON (56062-680-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | October 7, 2024 |
| 68016-058-12 | 68016-058 | Premier Value Alliance LLC | 1 BLISTER PACK in 1 CARTON (68016-058-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | October 25, 2018 |
| 11822-7834-2 | 11822-7834 | Rite Aid Corporation | 1 BLISTER PACK in 1 CARTON (11822-7834-2) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | January 24, 2020 |
| 11822-7834-9 | 11822-7834 | Rite Aid Corporation | 2 BLISTER PACK in 1 CARTON (11822-7834-9) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | January 24, 2020 |
| 70677-1062-1 | 70677-1062 | STRATEGIC SOURCING SERVICES | 2 BLISTER PACK in 1 CARTON (70677-1062-1) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | April 21, 2023 |
| 62011-0390-1 | 62011-0390 | Strategic Sourcing Services LLC | 2 BLISTER PACK in 1 CARTON (62011-0390-1) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | December 15, 2018 |
| 11673-177-12 | 11673-177 | TARGET Corporation | 2 BLISTER PACK in 1 CARTON (11673-177-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | October 9, 2019 |
| 36800-208-12 | 36800-208 | TOP CARE (Topco Associates LLC) | 2 BLISTER PACK in 1 CARTON (36800-208-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | July 2, 2021 |
| 63941-684-12 | 63941-684 | VALU MERCHANDISERS COMPANY | 2 BLISTER PACK in 1 CARTON (63941-684-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | October 10, 2023 |
| 0363-1176-08 | 0363-1176 | WALGREENS | 1 BLISTER PACK in 1 CARTON (0363-1176-08) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | March 19, 2020 |
| 0363-1176-12 | 0363-1176 | WALGREENS | 2 BLISTER PACK in 1 CARTON (0363-1176-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | June 15, 2018 |
| 49035-483-12 | 49035-483 | Wal-Mart Stores, Inc. | 2 BLISTER PACK in 1 CARTON (49035-483-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | January 1, 2019 |
| 46122-581 | 46122-581 | AMERISOURCE BERGEN | — | February 15, 2019 |
| 21130-835 | 21130-835 | Albertsons Companies | — | April 7, 2025 |
| 72288-313 | 72288-313 | Amazon.com Services LLC | — | February 12, 2024 |
| 69452-176 | 69452-176 | Bionpharma Inc. | — | August 2, 2019 |
| 69452-266 | 69452-266 | Bionpharma Inc. | — | August 2, 2019 |
| 70000-0461 | 70000-0461 | CARDINAL HEALTH | — | January 21, 2019 |
| 63868-876 | 63868-876 | CHAIN DRUG MARKETING ASSOCIATION INC. | — | January 25, 2019 |
| 83324-208 | 83324-208 | CHAIN DRUG MARKETING ASSOCIATION INC. | — | May 21, 2025 |
| 83324-209 | 83324-209 | CHAIN DRUG MARKETING ASSOCIATION INC. | — | May 21, 2025 |
| 69842-061 | 69842-061 | CVS Pharmacy, Inc. | — | December 4, 2018 |
| 53943-176 | 53943-176 | DISCOUNT DRUG MART, INC. | — | November 1, 2018 |
| 55910-176 | 55910-176 | DOLGENCORP, LLC | — | August 17, 2018 |
| 37808-988 | 37808-988 | HEB | — | December 4, 2018 |
| 30142-159 | 30142-159 | KROGER COMPANY | — | March 1, 2019 |
| 41250-210 | 41250-210 | MEIJER DISTRIBUTION INC | — | February 1, 2019 |
| 80136-851 | 80136-851 | Northeast Pharma | — | May 21, 2021 |
| 56062-680 | 56062-680 | PUBLIX SUPER MARKETS INC | — | October 7, 2024 |
| 68016-058 | 68016-058 | Premier Value Alliance LLC | — | October 25, 2018 |
| 11822-7834 | 11822-7834 | Rite Aid Corporation | — | January 24, 2020 |
| 70677-1062 | 70677-1062 | STRATEGIC SOURCING SERVICES | — | April 21, 2023 |
| 62011-0390 | 62011-0390 | Strategic Sourcing Services LLC | — | December 15, 2018 |
| 11673-177 | 11673-177 | TARGET Corporation | — | October 9, 2019 |
| 36800-208 | 36800-208 | TOP CARE (Topco Associates LLC) | — | July 2, 2021 |
| 63941-684 | 63941-684 | VALU MERCHANDISERS COMPANY | — | October 10, 2023 |
| 0363-1176 | 0363-1176 | WALGREENS | — | June 15, 2018 |
| 49035-483 | 49035-483 | Wal-Mart Stores, Inc. | — | January 1, 2019 |
Sources for 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 · 12 sections on this page.