warnings
stop use and ask a doctor if condition persists if pregnant or breast-feedingm ask a health professional before use Keep out of reach of children
Simethicone 250mg
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 250mg
- Generic name
- SIMETHICONE 250MG
- Manufacturer
- AMZ789 LLC
- Product type
- HUMAN OTC DRUG
- SPL set ID
- fcc2ef8b-9181-2c59-e053-6394a90adcc1
- SPL ID
- 2b3b212d-55b4-ca76-e063-6394a90a984e
- Version
- 2
- Effective date
- 2025-01-08
- Source export date
- 2026-09-28
- Source partition
- 13
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:36:58
| 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 250mg | openfda.brand_name | |
| generic name | SIMETHICONE 250MG | openfda.generic_name | |
| manufacturer name | AMZ789 LLC | openfda.manufacturer_name | |
| ndc | package | 73629-006-12 | openfda.package_ndc |
| ndc | product | 73629-006 | openfda.product_ndc |
| ndc11 | package | 73629000612 | derived:openfda.package_ndc |
| rxcui | 412111 | openfda.rxcui | |
| spl id | 2b3b212d-55b4-ca76-e063-6394a90a984e | id | |
| spl set id | fcc2ef8b-9181-2c59-e053-6394a90adcc1 | 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.