Cardinal Health Infants Gas Relief

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 (canonical bytes are SHA-256 checked before publication)

Brand name: Cardinal Health Infants Gas Relief
Generic name: SIMETHICONE
Manufacturer: CARDINAL HEALTH
Product type: HUMAN OTC DRUG
SPL set ID: e0dec270-dabb-4289-b5e0-bf37f9ddcbcd
SPL ID: 411c8ca0-57d6-df9e-e063-6394a90ae833
Version: 7
Effective date: 2025-10-14
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 05:25:25

Harmonized routes table
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.

Harmonized identifiers page 1 of 1 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M002	openfda.application_number
brand name		Cardinal Health Infants Gas Relief	openfda.brand_name
generic name		SIMETHICONE	openfda.generic_name
manufacturer name		CARDINAL HEALTH	openfda.manufacturer_name
ndc	package	70000-0051-1	openfda.package_ndc
ndc	product	70000-0051	openfda.product_ndc
ndc11	package	70000005101	derived:openfda.package_ndc
rxcui		198857	openfda.rxcui
spl id		411c8ca0-57d6-df9e-e063-6394a90ae833	id
spl set id		e0dec270-dabb-4289-b5e0-bf37f9ddcbcd	set_id
unii		92RU3N3Y1O	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Keep out of reach of children. Overdose warning: In case of overdose get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical even if you do not notice any signs or symptoms.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.