FDA.reportPublic FDA data

Sleep Disorder Synergy

Manufacturer
PHYTOPIA CO., LTD.
Effective date
2018-01-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:13

Label at a glance#

ProductSleep Disorder Synergy
Active ingredientBALSAM PERU OIL
Label structure9 sections

Storage and handling

Other Information Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

menthol(2.6%)

Balsam Peru Oil (2.4%)

Analgesic in the treatment of muscle pain

OTC - PURPOSE SECTION

Use

Helps relieve the condition of pain and stiffness.

DOSAGE & ADMINISTRATION SECTION

Dosage Suggestion

Adults 5ml maximum per day

Children 1ml maximum per day

INDICATIONS & USAGE SECTION

Directions

Apply on skin and gentle massage around painful area.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

EUCALYPTUS RADIATA LEAF OIL, JAVA CITRONELLA OIL, SUNFLOWER OIL, JOJOBA OIL, ROSEMARY OIL, EVENING PRIMROSE OIL, LEMON OIL, LAVENDER OIL

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Warnings

For external use only. Stop use and ask doctor if rash occurs. Keep out reach of children.

STORAGE AND HANDLING SECTION

Other Information

Protect this product from excessive heat

and direct sun.

WARNINGS SECTION

Warnings

For external use only. Stop use and ask doctor if rash occurs. Keep out reach of children.

PainAway-With natural Peppermint and Balsam Peru Oil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PainAwayPainAway

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70470-1221-52020-01-31C16284748780-19d75b9d1-121e-f424-e053-dadaa90a57ce70a3c24c-4fa7-9a9d-e053-2a91aa0a9b60

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70470-1221-5Sleep Disorder Synergy50 mg in 1 BOTTLE, DROPPEROIL501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70470-1221SLEEP DISORDER SYNERGY OIL [PHYTOPIA CO., LTD.]1Legacy NDC, 1 package rows20180710_70a3c24c-4fa7-9a9d-e053-2a91aa0a9b60.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70470-122170470-1221-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
BALSAM PERU OILDIK0395679ACTIB
EVENING PRIMROSE OIL3Q9L08K71NIACT
JOJOBA OIL724GKU717MIACT
LAVENDER OILZBP1YXW0H8IACT
SWEET MARJORAM OILICH7BE016EIACT
SUNFLOWER OIL3W1JG795YIIACT
CHAMOMILE FLOWER OIL60F80Z61A9IACT
GERANIUM OIL, ALGERIAN TYPE5Q1I94P4WGIACT

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
70a3e978-3a56-0bb3-e053-2a91aa0a62fe70a3c24c-4fa7-9a9d-e053-2a91aa0a9b602018-01-10WarningsExact identifier
spl id: 70a3e978-3a56-0bb3-e053-2a91aa0a62fe
spl set id: 70a3c24c-4fa7-9a9d-e053-2a91aa0a9b60

Reported adverse events (FAERS/openFDA)#

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