warnings
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
Anti-Diarrheal
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Anti-Diarrheal
- Generic name
- LOPERAMIDE HYDROCHLORIDE
- Manufacturer
- Premier Value Alliance LLC
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 0dd97bfb-67ce-472f-9b23-15f613bb3135
- SPL ID
- f0fe4551-a400-5bec-e053-2a95a90a55df
- Version
- 3
- Effective date
- 2022-12-29
- Source export date
- 2026-10-27
- Source partition
- 3
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-27/d7629e6f844435cfe6cb0cf8c5341c46775ea16c5af42c77a22a2ffe820a2cd2/drug-label-0003-of-0014.json.zip
- Source manifest SHA-256
- 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
- Import run
- 20261027T193451Z
- Imported at
- 2026-10-27 19:48:45
| Harmonized routes |
|---|
| ORAL |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | NDA | 021855 | derived:openfda.application_number |
| application number | NDA021855 | openfda.application_number | |
| brand name | Anti-Diarrheal | openfda.brand_name | |
| generic name | LOPERAMIDE HYDROCHLORIDE | openfda.generic_name | |
| manufacturer name | Premier Value Alliance LLC | openfda.manufacturer_name | |
| ndc | package | 68016-058-12 | openfda.package_ndc |
| ndc | product | 68016-058 | openfda.product_ndc |
| ndc11 | package | 68016005812 | derived:openfda.package_ndc |
| rxcui | 978006 | openfda.rxcui | |
| spl id | f0fe4551-a400-5bec-e053-2a95a90a55df | id | |
| spl set id | 0dd97bfb-67ce-472f-9b23-15f613bb3135 | set_id | |
| unii | 77TI35393C | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.