warnings
Warnings Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.
Infants Simethicone Drops
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
- Infants Simethicone Drops
- Generic name
- INFANTS SIMETHICONE DROPS
- Manufacturer
- PAI Holdings, LLC dba PAI Pharma
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 235f458e-c275-4bc1-9c0f-e007c4040649
- SPL ID
- b858c7a8-bd06-4880-8c83-7c3a84f59592
- Version
- 1
- Effective date
- 2026-06-03
- Source export date
- 2026-10-12
- Source partition
- 7
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:59:02
| 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 | Infants Simethicone Drops | openfda.brand_name | |
| generic name | INFANTS SIMETHICONE DROPS | openfda.generic_name | |
| manufacturer name | PAI Holdings, LLC dba PAI Pharma | openfda.manufacturer_name | |
| ndc | package | 0121-1094-03 | openfda.package_ndc |
| ndc | package | 0121-1094-01 | openfda.package_ndc |
| ndc | product | 0121-1094 | openfda.product_ndc |
| ndc11 | package | 00121109401 | derived:openfda.package_ndc |
| ndc11 | package | 00121109403 | derived:openfda.package_ndc |
| rxcui | 198857 | openfda.rxcui | |
| spl id | b858c7a8-bd06-4880-8c83-7c3a84f59592 | id | |
| spl set id | 235f458e-c275-4bc1-9c0f-e007c4040649 | 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.