Mylicon Infants Gas Relief Original

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 Original
Generic name: SIMETHICONE
Manufacturer: Infirst Healthcare
Product type: HUMAN OTC DRUG
SPL set ID: 395be942-d883-4bcb-8811-6fe1521d5a92
SPL ID: 0bb18b4c-fbe3-8d2a-e063-6394a90a4f5c
Version: 5
Effective date: 2024-01-01
Source export date: 2026-10-30
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-30/8d15bdc5962e7531569eaeb5b1b2e4919574d40a6782ab67345a27b890175a00/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 19:55:16

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 Original	openfda.brand_name
generic name		SIMETHICONE	openfda.generic_name
manufacturer name		Infirst Healthcare	openfda.manufacturer_name
ndc	package	62372-630-30	openfda.package_ndc
ndc	package	62372-630-15	openfda.package_ndc
ndc	product	62372-630	openfda.product_ndc
ndc11	package	62372063015	derived:openfda.package_ndc
ndc11	package	62372063030	derived:openfda.package_ndc
rxcui		198857	openfda.rxcui
rxcui		809376	openfda.rxcui
spl id		0bb18b4c-fbe3-8d2a-e063-6394a90a4f5c	id
spl set id		395be942-d883-4bcb-8811-6fe1521d5a92	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.