warnings
Warnings If pregnant or breast-feeding, ask a health professional before use.
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
- Simethicone
- Generic name
- SIMETHICONE
- Manufacturer
- Advance Pharmaceutical Inc.
- Product type
- HUMAN OTC DRUG
- SPL set ID
- e11928e8-b9db-43c5-972b-33b325090dfc
- SPL ID
- 7d3cccab-252a-cd80-e053-2a91aa0acbcc
- Version
- 4
- Effective date
- 2018-12-17
- 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 05:31:57
| 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 | part332 | openfda.application_number | |
| brand name | Simethicone | openfda.brand_name | |
| generic name | SIMETHICONE | openfda.generic_name | |
| manufacturer name | Advance Pharmaceutical Inc. | openfda.manufacturer_name | |
| ndc | package | 17714-040-60 | openfda.package_ndc |
| ndc | product | 17714-040 | openfda.product_ndc |
| ndc11 | package | 17714004060 | derived:openfda.package_ndc |
| rxcui | 314221 | openfda.rxcui | |
| spl id | 7d3cccab-252a-cd80-e053-2a91aa0acbcc | id | |
| spl set id | e11928e8-b9db-43c5-972b-33b325090dfc | 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.