warnings
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SIMETHICONE 80MG
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
- SIMETHICONE 80MG
- Generic name
- SIMETHICONE
- Manufacturer
- Gendose Pharmaceuticals, LLC
- Product type
- HUMAN OTC DRUG
- SPL set ID
- e7f470cf-f036-afd9-e053-2995a90a9186
- SPL ID
- 0e765edc-264e-533a-e063-6394a90a7c53
- Version
- 6
- Effective date
- 2024-01-08
- Source export date
- 2026-09-28
- Source partition
- 5
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:32:25
| 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 number | M002 | openfda.application_number | |
| brand name | SIMETHICONE 80MG | openfda.brand_name | |
| generic name | SIMETHICONE | openfda.generic_name | |
| manufacturer name | Gendose Pharmaceuticals, LLC | openfda.manufacturer_name | |
| ndc | package | 77333-812-10 | openfda.package_ndc |
| ndc | package | 77333-812-25 | openfda.package_ndc |
| ndc | product | 77333-812 | openfda.product_ndc |
| ndc11 | package | 77333081210 | derived:openfda.package_ndc |
| ndc11 | package | 77333081225 | derived:openfda.package_ndc |
| rxcui | 314216 | openfda.rxcui | |
| spl id | 0e765edc-264e-533a-e063-6394a90a7c53 | id | |
| spl set id | e7f470cf-f036-afd9-e053-2995a90a9186 | set_id | |
| 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.