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
Loperamide Hydrochloride and Simethicone
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
- Loperamide Hydrochloride and Simethicone
- Generic name
- LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
- Manufacturer
- Aurohealth LLC
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 769e3cc0-6be9-4ab6-88e1-08803d698ef7
- SPL ID
- 32e30a2b-c658-49da-a9ff-e94279e7f8d3
- Version
- 5
- Effective date
- 2025-01-07
- Source export date
- 2026-09-28
- Source partition
- 14
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0014-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/db99fd80353afecef4949b48edcaa018be72b966b2360184251eb14df43743f9/drug-label-0014-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:41:01
| 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 | ANDA | 211059 | derived:openfda.application_number |
| application number | ANDA211059 | openfda.application_number | |
| brand name | Loperamide Hydrochloride and Simethicone | openfda.brand_name | |
| generic name | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | openfda.generic_name | |
| manufacturer name | Aurohealth LLC | openfda.manufacturer_name | |
| ndc | package | 58602-869-80 | openfda.package_ndc |
| ndc | package | 58602-869-76 | openfda.package_ndc |
| ndc | product | 58602-869 | openfda.product_ndc |
| ndc11 | package | 58602086980 | derived:openfda.package_ndc |
| ndc11 | package | 58602086976 | derived:openfda.package_ndc |
| rxcui | 978001 | openfda.rxcui | |
| spl id | 32e30a2b-c658-49da-a9ff-e94279e7f8d3 | id | |
| spl set id | 769e3cc0-6be9-4ab6-88e1-08803d698ef7 | set_id | |
| unii | 77TI35393C | openfda.unii | |
| unii | 92RU3N3Y1O | 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.