Active ingredient
Loperamide
200 finished FDA listings contain Loperamide as their only active ingredient; 39 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- LOPERAMIDE HYDROCHLORIDE
- Dosage forms
- Capsule, Capsule, Liquid Filled, Solution, Suspension, Tablet, Tablet, Coated, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 117
- Strengths listed
- 1 mg/7.5ml · 2 mg/1
- Brand names in FDA listings
- Amazon Basic Care Loperamide Hydrochloride, Anti Diarrheal, Anti-Diarrheal, Anti-Diarrheal, 24/7 Life By 7-Eleven, Anti-Diarrheal, Caseys 4good, Anti-Diarrheal, Circle K, Anti-Diarrheal, Cvp Health, Basic Care Loperamide Hydrochloride, Berkley And Jensen Anti Diarrheal, Careone Diarrhea Control, Dg Health Anti Diarrheal, Equaline Loperamide Hydrochloride, Equate Diarrhea Control, Equate Loperamide Hydrochloride, Foster And Thrive Anti Diarrheal, Foster And Thrive Anti-Diarrheal, Good Neighbor Pharmacy Loperamide Hydrochloride, Good Sense Anti Diarrheal, Good Sense Antidiarrheal, Handy Solutions Anti-Diarrheal, Imodium A-D, Injoy Diarrhea Relief, Leader Anti Diarrheal, Lil Drug Store Anti-Diarrheal, Loperamide Hydrochloride, Loperamide Hydrochloride 2mg, Medique Diamode, Private Label Distributor, Topcare Anti Diarrheal, Topcare Loperamide Hydrochloride, Up And Up Anti Diarrheal, Welmate Anti Diarrheal Loperamide Hcl, Welmate Anti Diarrheal Loperamide Hcl Softgels
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 6468
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 019487 | KENVUE BRANDS | 1988-03-01 | 1 |
| ANDA 072741 | MYLAN | 1991-09-18 | 7 |
| ANDA 073192 | TEVA | 1992-04-30 | 10 |
| ANDA 074091 | OHM LABS | 1992-12-10 | 22 |
| ANDA 075232 | L PERRIGO CO | 2000-01-06 | 25 |
| ANDA 076497 | LNK | 2003-06-10 | 36 |
| NDA 021855 | BIONPHARMA | 2005-08-04 | 28 |
| ANDA 091292 | PERRIGO R AND D | 2011-05-20 | 28 |
| ANDA 206548 | AUROBINDO PHARMA | 2015-12-15 | 8 |
| ANDA 213070 | ONESOURCE | 2021-08-11 | 3 |
| ANDA 215001 | EDENBRIDGE PHARMS | 2021-10-06 | 6 |
| ANDA 215579 | BIONPHARMA | 2021-10-22 | 4 |
| ANDA 216876 | RUBICON RESEARCH | 2023-01-26 | 3 |
| ANDA 217471 | ZYDUS LIFESCIENCES | 2023-03-23 | 2 |
| ANDA 218122 | AUROBINDO PHARMA LTD | 2023-09-05 | 10 |
| ANDA 220100 | BIONPHARMA | 2025-09-19 | 3 |
| ANDA 220153 | PHARMAZONE | 2025-11-17 | 2 |
| ANDA 220372 | AUROBINDO PHARMA | 2025-12-29 | 2 |
Official labeling on DailyMed
- LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED [YYBA CORP] · version 3 · 2026-09-10
- LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED [AUROHEALTH LLC] · version 2 · 2026-09-07
- ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [CVS PHARMACY] · version 10 · 2026-09-07
- LOPERAMIDE HCL CAPSULE [DIRECT_RX] · version 1 · 2026-08-26
- ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [CVS PHARMACY] · version 6 · 2026-08-20
- ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [DOLGENCORP, LLC] · version 5 · 2026-08-20
- ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [REDPHARM DRUG] · version 1 · 2026-08-19
- LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED [STRIDES PHARMA, INC.] · version 7 · 2026-08-17
- LOPERAMIDE HYDROCHLORIDE TABLET [YYBA CORP] · version 2 · 2026-08-11
- LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HCL) SOLUTION [AMAZON.COM SERVICES LLC] · version 2 · 2026-08-10
- LOPERAMIDE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.] · version 7 · 2026-08-10
- LOPERAMIDE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH 107, LLC] · version 13 · 2026-08-07
Showing the 12 most recent of 194 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.