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
- WALMART INC.
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 12940c3b-dc58-31fb-e063-6294a90ae880
- SPL ID
- d5cdb88f-1858-4e14-a988-2db6865255c5
- Version
- 3
- Effective date
- 2025-01-07
- Source export date
- 2026-10-30
- Source partition
- 8
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-30/023bc8d8aae5addb7530087bbbdb169b3ccbf36764f15b8ca67db07e1e5aea8b/drug-label-0008-of-0014.json.zip
- Source manifest SHA-256
- b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
- Import run
- 20261102T182004Z
- Imported at
- 2026-11-02 19:10:08
| 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 | WALMART INC. | openfda.manufacturer_name | |
| ndc | package | 79903-223-12 | openfda.package_ndc |
| ndc | package | 79903-223-24 | openfda.package_ndc |
| ndc | product | 79903-223 | openfda.product_ndc |
| ndc11 | package | 79903022312 | derived:openfda.package_ndc |
| ndc11 | package | 79903022324 | derived:openfda.package_ndc |
| rxcui | 978001 | openfda.rxcui | |
| spl id | d5cdb88f-1858-4e14-a988-2db6865255c5 | id | |
| spl set id | 12940c3b-dc58-31fb-e063-6294a90ae880 | 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.