warnings
Warnings Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.
Childrens 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
- Childrens Simethicone Drops
- Generic name
- CHILDRENS SIMETHICONE DROPS
- Manufacturer
- PAI Holdings, LLC dba PAI Pharma
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 6e26ffbe-4c5b-4689-99bc-88b39ed40a25
- SPL ID
- 71dcffb3-3fc3-4263-9e4e-b96f04721510
- Version
- 1
- Effective date
- 2026-06-04
- Source export date
- 2026-11-06
- Source partition
- 2
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-11-06/4dafeb36642dffb72e2138939a956de402f722ea8c14c08cd87068efd3669f01/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
- Import run
- 20261108T063105Z
- Imported at
- 2026-11-08 06:48:42
| 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 | Childrens Simethicone Drops | openfda.brand_name | |
| generic name | CHILDRENS SIMETHICONE DROPS | openfda.generic_name | |
| manufacturer name | PAI Holdings, LLC dba PAI Pharma | openfda.manufacturer_name | |
| ndc | package | 0121-1095-01 | openfda.package_ndc |
| ndc | package | 0121-1095-03 | openfda.package_ndc |
| ndc | product | 0121-1095 | openfda.product_ndc |
| ndc11 | package | 00121109503 | derived:openfda.package_ndc |
| ndc11 | package | 00121109501 | derived:openfda.package_ndc |
| rxcui | 198857 | openfda.rxcui | |
| spl id | 71dcffb3-3fc3-4263-9e4e-b96f04721510 | id | |
| spl set id | 6e26ffbe-4c5b-4689-99bc-88b39ed40a25 | 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.