FDA.reportPublic FDA data

SleepEase

Manufacturer
Eight & Company L.L.C | King Bio Inc | Apotheca Company
Effective date
2025-12-18
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:36:20

Label at a glance#

ProductSleepEase
Active ingredientAQUILEGIA VULGARIS, AVENA SATIVA FLOWERING TOP, MATRICARIA CHAMOMILLA WHOLE, ARABICA COFFEE BEAN, CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT, HOPS, DIBASIC POTASSIUM PHOSPHATE, PASSIFLORA INCARNATA FLOWERING TOP, VALERIAN, ZINC
Label structure9 sections

Dosage and administration

Adults and children over 12: 2 sprays into the mouth at bedtime and if sleep is interrupted.Children Under 12: consult a health care professional.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Aquilegia 4X, Avena 4X, Chamomilla 4X, Coffea cruda 200C, Cypripedium 4X, Humulus 4X, Kali phos 12X, Passiflora 4X, Valeriana 4X, Zinc met 12X.

WARNINGS:

WARNINGS SECTION

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.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

INDICATIONS:

INDICATIONS & USAGE SECTION

Temporarily relieves the common symptoms of sleeplessness, including:

º wakefulness

º restlessness

º emotional stress and anxiety

º caffeine sensitivity

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12: 2 sprays into the mouth at bedtime and if sleep is interrupted.Children Under 12: consult a health care professional.

OTHER INFORMATION:

OTHER SAFETY INFORMATION

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

PURPOSE:

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

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Non-GMO Glycerin, organic alcohol 20% v/v, purified water.

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SleepEase LBLSleepEase LBL

NDC 61096-2001-1

sprayology

SleepEase

RELIEVES 

RESTLESSNESS

HOMEOPATHIC ORAL SPRAY

1.38 fl.oz (41 ml)

SleepEase LBLSleepEase LBL

SleepEase CNTSleepEase CNT

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130361096000115GTIN-13: 0361096000115
EAN-13: 0361096000115
GTIN-12: 361096000115
UPC-A: 361096000115
GTIN storage (14 digits): 00361096000115		ETCO0015 SleepEase CTN 2-15-19.jpg

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
61096-2001-12023-09-27C16284748780-1f386c64a-0f39-0266-e053-dadaa90a7c1aSleepEase
61096-2001-12023-01-30C16284748780-1f386c64a-0f39-0266-e053-dadaa90a7c1aSleepEase

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61096-2001-1SleepEase1 in 1 CARTONLIQUID16
61096-2001-1SleepEase41 mL in 1 BOTTLE, SPRAYLIQUID416

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
61096-200161096-2001-1

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 CHAMOMILLA WHOLEG0R4UBI2ZZACTIB
ARABICA COFFEE BEAN3SW678MX72ACTIB
CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT21Y9GZ1LZAACTIB
HOPS01G73H6H83ACTIB
DIBASIC POTASSIUM PHOSPHATECI71S98N1ZACTIB
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
SleepEaseAQUILEGIA, AVENA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM, HUMULUS, KALI PHOS, PASSIFLORA, VALERIANA, ZINC METEight & Company L.L.C9bd5fdc8-56b3-4e94-bd2f-1bfa9475c2e62025-12-18WarningsExact identifier
ndc (package): 61096-2001-1
ndc (product): 61096-2001
ndc11 (package): 61096200101
spl id: cc630075-d315-46fe-a50d-3fb7f0215eb4
spl set id: 9bd5fdc8-56b3-4e94-bd2f-1bfa9475c2e6

Reported adverse events (FAERS/openFDA)#

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