Mylicon Infants Gas Relief Dye Free

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: Mylicon Infants Gas Relief Dye Free
Generic name: SIMETHICONE
Manufacturer: Infirst Healthcare
Product type: HUMAN OTC DRUG
SPL set ID: 3324139a-ed22-43af-859d-e7af19a24ee9
SPL ID: 0bb1b812-762c-9bc2-e063-6394a90a79d2
Version: 6
Effective date: 2024-01-01
Source export date: 2026-10-27
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/b7a5e61d87a3b8f87f4c3ff7b526bfbf6baf84c840f565574c7d83d4083e2b38/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:46:37

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 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M002	openfda.application_number
brand name		Mylicon Infants Gas Relief Dye Free	openfda.brand_name
generic name		SIMETHICONE	openfda.generic_name
manufacturer name		Infirst Healthcare	openfda.manufacturer_name
ndc	package	62372-650-15	openfda.package_ndc
ndc	package	62372-650-30	openfda.package_ndc
ndc	product	62372-650	openfda.product_ndc
ndc11	package	62372065030	derived:openfda.package_ndc
ndc11	package	62372065015	derived:openfda.package_ndc
rxcui		198857	openfda.rxcui
rxcui		809376	openfda.rxcui
spl id		0bb1b812-762c-9bc2-e063-6394a90a79d2	id
spl set id		3324139a-ed22-43af-859d-e7af19a24ee9	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.