FDA.reportPublic FDA data

Sprayology SleepEase

Manufacturer
Eight and Company
Effective date
2016-07-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:08:06

Label at a glance#

ProductSprayology SleepEase
Active ingredientAQUILEGIA VULGARIS, AVENA SATIVA FLOWERING TOP, MATRICARIA RECUTITA, ARABICA COFFEE BEAN, CYPRIPEDIUM PARVIFOLUM ROOT, HOPS, POTASSIUM PHOSPHATE, DIBASIC, PASSIFLORA INCARNATA FLOWERING TOP, VALERIAN, ZINC
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Aquilegia vulgaris 2X, Avena sativa 2X, Chamomilla 2X, Coffea cruda 200C, Cypripedium pubescens 3X, Humulus lupulus 3X, Kali phosphoricum 12X, Passiflora incarnata 2X, Valeriana officinalis 2X, Zincum metallicum 12X.

WARNINGS SECTION

Warnings: If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

INDICATIONS & USAGE SECTION

Temporarily relieves the common symptoms of sleeplessness, including:

  • wakefulness
  • restlessness
  • emotional stress and anxiety
  • caffeine sensitivity

DOSAGE & ADMINISTRATION SECTION

Directions:

  • Adults and children over 12: 2 sprays into the mouth at bedtime and if sleep is interrupted.
  • Ages 2 to 12: 1 spray into the mouth at bedtime and if sleep is interrupted.
  • Under age 2: consult a health care professional.

OTHER SAFETY INFORMATION

Other Information: Do not use if the transparent seal around spray bottle is broken or missing.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Glycerin 10%, v/v, non-GMO organic alcohol 9% v/v and purified water.

OTC - PURPOSE SECTION

Temporarily relieves the common symptoms of sleeplessness, including:

° wakefulness

° restlessness

° emotional stress and anxiety

° caffeine sensitivity

° natural

° gluten free

° no artifical flavors or colors

° vegan

° no known negative side effects

° no known negative drug interactions

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61096-1001-22020-01-31C16284748780-19d75b9d0-6dc6-f424-e053-dadaa90a57ceSprayology SleepEase

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61096-1001-2Sprayology SleepEase1 in 1 CARTONLIQUID11
61096-1001-2Sprayology SleepEase41 mL in 1 BOTTLE, SPRAYLIQUID411

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61096-1001SPRAYOLOGY SLEEPEASE (AQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, KALI PHOSPHORICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, ZINCUM METALLICUM) LIQUID [EIGHT AND COMPANY]1Legacy NDC, 2 package rows20160728_5e67c4d8-fca8-4450-817a-009841c8c163.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61096-100161096-1001-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
AQUILEGIA VULGARIS8POZ61U1G2ACTIB
AVENA SATIVA FLOWERING TOPMA9CQJ3F7FACTIB
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
ARABICA COFFEE BEAN3SW678MX72ACTIB
CYPRIPEDIUM PARVIFOLUM ROOT21Y9GZ1LZAACTIB
HOPS01G73H6H83ACTIB
POTASSIUM PHOSPHATE, DIBASICCI71S98N1ZACTIB
PASSIFLORA INCARNATA FLOWERING TOPCLF5YFS11OACTIB
VALERIANJWF5YAW3QWACTIB
ZINCJ41CSQ7QDSACTIB
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

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
9aa92659-233c-4bc0-a2ef-d246470365ec5e67c4d8-fca8-4450-817a-009841c8c1632016-07-28WarningsExact identifier
spl id: 9aa92659-233c-4bc0-a2ef-d246470365ec
spl set id: 5e67c4d8-fca8-4450-817a-009841c8c163

Reported adverse events (FAERS/openFDA)#

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