warnings
Warnings Keep out of reach of children. In case of overdose get medical help or contact a Poison Control Center right away.
SIMETHICONE INFANT Gas Relief 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
- SIMETHICONE INFANT Gas Relief Drops
- Generic name
- SIMETHICONE
- Manufacturer
- AARNA USA Inc.
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 9b0fde90-35ae-498e-99cc-d120f1a87182
- SPL ID
- 3b14f103-c7f9-f905-e063-6294a90a0e2c
- Version
- 3
- Effective date
- 2025-07-29
- Source export date
- 2026-10-12
- Source partition
- 12
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:54:07
| 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 INFANT Gas Relief Drops | openfda.brand_name | |
| generic name | SIMETHICONE | openfda.generic_name | |
| manufacturer name | AARNA USA Inc. | openfda.manufacturer_name | |
| ndc | package | 82568-0017-3 | openfda.package_ndc |
| ndc | package | 82568-0017-4 | openfda.package_ndc |
| ndc | product | 82568-0017 | openfda.product_ndc |
| ndc11 | package | 82568001703 | derived:openfda.package_ndc |
| ndc11 | package | 82568001704 | derived:openfda.package_ndc |
| rxcui | 198857 | openfda.rxcui | |
| spl id | 3b14f103-c7f9-f905-e063-6294a90a0e2c | id | |
| spl set id | 9b0fde90-35ae-498e-99cc-d120f1a87182 | 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.