FDA.reportPublic FDA data

somease

Manufacturer
Biotico Health Canada Limited
Effective date
2017-12-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:09:09

Label at a glance#

Productsomease
Active ingredientMELATONIN
Label structure10 sections

Storage and handling

Store in a cool dry place, at a temperature not exceeding 25° C, away from light and direct heat.

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Melatonin 1 mg per spray

OTC - PURPOSE SECTION

Relieve symptoms associated with sleeplessness

INDICATIONS & USAGE SECTION

Solution for difficult sleeping. 

For people with sleeplessness due to stress or for people with insomnia.

Warnings:

WARNINGS SECTION

If you are pregnant, nursing, taking any medications, planning any medical or surgical procedure, or have any medical condition, consult your physician before use. Do not exceed the recommended daily dose.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

Usage Instructions:

DOSAGE & ADMINISTRATION SECTION

Take 3 to 5 sprays before going to bed, preferably under the tongue.

Doses per bottle: 250 Sprays

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Water, Polyoxyethylene sorbitan monooleate, Glycerol, Medium-chain triglycerides, L–ascorbyl palmitate, Flavouring, Potassium sorbate, Citric acid, Sucralose.

Storage Instructions:

STORAGE AND HANDLING SECTION

Store in a cool dry place, at a temperature not exceeding 25° C, away from light and direct heat.

SPL UNCLASSIFIED SECTION

Melatonin Oral Spray

For Busy People

For people with insomnia

For people with sleeplessness due to stress

Sleep faster, sleep better. 4 times stronger and 3 times faster than other sleep products.*

Developed in Italy, Somease is the natural solution for difficult sleeping. Somease is a sublingual food spray containing melatonin that reduces the time it takes to fall asleep and helps you wake up without morning sleepiness and discomfort. Somease’s patented nano emulsion allows for rapid absorption (5 minutes) by the body.

*compared to sleep products in capsule form containing melatonin.

Non-GMO

Gluten Free

Nut Free

Somease,Toronto, Ontario, Canada

www.somease.com

Made in Italy

Biotico Health Canada Limited Toronto, Ontario M9W 6V6 CANADA

Email us at: hello@bioti.co

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71902-100-012020-01-31C16284748780-19d75b9d0-9b62-f424-e053-dadaa90a57cesomease
71902-100-022020-01-31C16284748780-19d75b9d0-9b62-f424-e053-dadaa90a57cesomease

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71902-100-01somease50 mL in 1 BOTTLESPRAY, METERED501
71902-100-02somease15 mL in 1 BOTTLESPRAY, METERED151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71902-100SOMEASE (MELATONIN) SPRAY, METERED [BIOTICO HEALTH CANADA LIMITED]1Legacy NDC, 2 package rows20180115_57e6b4dc-e244-4a76-826a-d40bc7c8baf8.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71902-10071902-100-01, 71902-100-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
MELATONINJL5DK93RCLACTIB
WATER059QF0KO0RIACT
PEG-6 SORBITAN OLEATE58O7V09UCIIACT
GLYCERINPDC6A3C0OXIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ASCORBYL PALMITATEQN83US2B0NIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bedca3e4-3a46-4d7b-ada3-d9d95fb3484857e6b4dc-e244-4a76-826a-d40bc7c8baf82017-12-01WarningsExact identifier
spl id: bedca3e4-3a46-4d7b-ada3-d9d95fb34848
spl set id: 57e6b4dc-e244-4a76-826a-d40bc7c8baf8

Reported adverse events (FAERS/openFDA)#

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