warnings
Warnings Keep out of reach of children TAMPER EVIDENT: DO NOT USE IF SAFETY POUCH LOOKS TO BE TEMPERED OR OPEN
Simethicone 125 mg
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 125 mg
- Generic name
- SIMETHICONE
- Manufacturer
- ATLANTIC BIOLOGICALS CORP.
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 4ce98db3-c7a6-4627-88c5-9de302a53188
- SPL ID
- 38930d1f-1f60-1fa5-e063-6394a90a5c21
- Version
- 4
- Effective date
- 2025-06-27
- Source export date
- 2026-09-28
- Source partition
- 4
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:25:12
| 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 125 mg | openfda.brand_name | |
| generic name | SIMETHICONE | openfda.generic_name | |
| manufacturer name | ATLANTIC BIOLOGICALS CORP. | openfda.manufacturer_name | |
| ndc | package | 17856-0137-2 | openfda.package_ndc |
| ndc | package | 17856-0137-1 | openfda.package_ndc |
| ndc | product | 17856-0137 | openfda.product_ndc |
| ndc11 | package | 17856013702 | derived:openfda.package_ndc |
| ndc11 | package | 17856013701 | derived:openfda.package_ndc |
| rxcui | 314221 | openfda.rxcui | |
| spl id | 38930d1f-1f60-1fa5-e063-6394a90a5c21 | id | |
| spl set id | 4ce98db3-c7a6-4627-88c5-9de302a53188 | 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.