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
- 2026-10-27
- 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/2026-10-27/35717de05250cd386420cc8ede3b6010b48d18eea2af59afb0617fcabca634ec/drug-label-0005-of-0014.json.zip
- Source manifest SHA-256
- 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
- Import run
- 20261027T193451Z
- Imported at
- 2026-10-27 20:03:53
| 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.