warnings
Warnings If pregnant or breast-feeding, ask a health professional before use.
Simethicone
openFDA label record#
Cross-check layer: This is openFDA JSON-derived label data. Use the corresponding DailyMed SPL as the canonical label.
Verified complete openFDA source JSON
- Brand name
- Simethicone
- Generic name
- SIMETHICONE
- Manufacturer
- Aphena Pharma Solutions - Tennessee, LLC
- Product type
- HUMAN OTC DRUG
- SPL set ID
- da0cc98e-1692-405a-ab81-420d6f9df6de
- SPL ID
- 2b4cfbd3-496e-100d-e063-6294a90aba52
- Version
- 3
- Effective date
- 2025-01-09
- Source export date
- 2026-08-01
- Source partition
- 6
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-08-01/4d7120b2932458966cd5c2f0e3ab49319f616f09498d059c9ff283a8dac64565/drug-label-0006-of-0014.json.zip
- Source manifest SHA-256
- bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
- Import run
- 20260801T225920Z
- Imported at
- 2026-08-01 23:11:35
| 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 | openfda.brand_name | |
| generic name | SIMETHICONE | openfda.generic_name | |
| manufacturer name | Aphena Pharma Solutions - Tennessee, LLC | openfda.manufacturer_name | |
| ndc | package | 71610-607-04 | openfda.package_ndc |
| ndc | product | 71610-607 | openfda.product_ndc |
| ndc11 | package | 71610060704 | derived:openfda.package_ndc |
| rxcui | 314216 | openfda.rxcui | |
| spl id | 2b4cfbd3-496e-100d-e063-6294a90aba52 | id | |
| spl set id | da0cc98e-1692-405a-ab81-420d6f9df6de | set_id | |
| unii | 92RU3N3Y1O | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.