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
- Richmond Pharmaceuticals, Inc.
- Product type
- HUMAN OTC DRUG
- SPL set ID
- f4be1c0d-01fc-4681-9068-905ed3184534
- SPL ID
- 5cc86981-732a-038f-e053-2991aa0a19d4
- Version
- 2
- Effective date
- 2017-10-30
- Source export date
- 2026-10-30
- Source partition
- 1
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-30/772d0e4623a189b47f3ab71d7d51f9b3c89c5526f4cf3d218e1c921bb964b80c/drug-label-0001-of-0014.json.zip
- Source manifest SHA-256
- b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
- Import run
- 20261102T182004Z
- Imported at
- 2026-11-02 18:28:31
| 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 | Richmond Pharmaceuticals, Inc. | openfda.manufacturer_name | |
| ndc | package | 54738-518-01 | openfda.package_ndc |
| ndc | product | 54738-518 | openfda.product_ndc |
| ndc11 | package | 54738051801 | derived:openfda.package_ndc |
| rxcui | 314216 | openfda.rxcui | |
| spl id | 5cc86981-732a-038f-e053-2991aa0a19d4 | id | |
| spl set id | f4be1c0d-01fc-4681-9068-905ed3184534 | 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.