FDA.reportPublic FDA data

Sleep Now Remedy

Manufacturer
Living Well Remedies, LLC
Effective date
2018-10-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:10:27

Label at a glance#

ProductSleep Now Remedy
Active ingredientAVENA SATIVA FLOWERING TOP, CAMPHOR (NATURAL), ARABICA COFFEE BEAN, CYPRIPEDIUM PARVIFOLUM ROOT, STRYCHNOS IGNATII SEED, PASSIFLORA INCARNATA FLOWERING TOP, VALERIAN, ACONITUM NAPELLUS, HORSE CHESTNUT, ARSENIC TRIOXIDE, CINCHONA OFFICINALIS BARK, HYOSCYAMUS NIGER, PULSATILLA VULGARIS
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Official HPUS: Aconitum napellus, Aesculus hippocastanum, flos, Arsenicum album, Avena sativa, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Ignatia amara, Passiflora incarnata, Pulsatilla, Valeriana officinalis. Equal volumes of each ingredient in 10X, 30X, 1LM potencies.

*Claims based on traditional homeopathic practice, not accepted medical evidence.

Not FDA evaluated.

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

INDICATIONS & USAGE SECTION

Uses: May help to relieve sleeplessness, inability to fall asleep or stay asleep, restless light sleeping, tossing and turning, overactive mind, worry.*

WARNINGS SECTION

Warnings: Stop use and ask a doctor, if symptoms persist or worsen. If pregnant or breast-feeding, consult a healthcare professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions: ​Before bedtime, spray 6 times directly into mouth under your tongue. Take up to 3 additional doses (6 sprays/dose) as needed throughout the night.

OTHER SAFETY INFORMATION

Other Information: Do not use if safety seal is broken or missing. Store at room temperature away from heat and sunlight.

INACTIVE INGREDIENT SECTION

Inactive ingredients: Citric acid, potassium sorbate, purified water.

OTC - QUESTIONS SECTION

​Distributed by:

Living Well Remedies, LLC

P.O. Box 704, Franklin Lakes, NJ 07417

For more information visit:

​www.LivingWellRemedies.com

Made in the USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LIVING WELL REMEDIES®

​SLEEP NOW

Remedy™

​For relief of sleeplesness,

​inability to fall asleep,

and restless light sleeping

Nature's Homeopathic Medicine

2 fl oz (59.1mL)

Sleep Now RemedySleep Now Remedy

OTC - PURPOSE SECTION

​For relief of sleeplessness,

inability to fall asleep,

and restless light sleeping

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53852-1016-22020-01-31C16284748780-19d75b9d0-90c7-f424-e053-dadaa90a57ceSleep Now Remedy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53852-1016-2Sleep Now Remedy59 mL in 1 BOTTLE, SPRAYLIQUID591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53852-1016SLEEP NOW REMEDY (ACONITUM NAPELLUS, AAESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSYAMUS NIGER, IGNATIA AMARA, PASSIFLORA INCARNATA, PULSATILLA, VALERIANA OFFICINALIS) LIQUID [LIVING WELL REMEDIES, LLC]1Legacy NDC, 1 package rows20181010_c940517a-1353-421f-a3c2-b49538f7764d.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53852-101653852-1016-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVENA SATIVA FLOWERING TOPMA9CQJ3F7FACTIB
CAMPHOR (NATURAL)N20HL7Q941ACTIB
ARABICA COFFEE BEAN3SW678MX72ACTIB
CYPRIPEDIUM PARVIFOLUM ROOT21Y9GZ1LZAACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
PASSIFLORA INCARNATA FLOWERING TOPCLF5YFS11OACTIB
VALERIANJWF5YAW3QWACTIB
ACONITUM NAPELLUSU0NQ8555JDACTIB
HORSE CHESTNUT3C18L6RJAZACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
HYOSCYAMUS NIGER4WRK2153H3ACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

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
966a85da-5069-4ed6-9648-91937140f1d1c940517a-1353-421f-a3c2-b49538f7764d2018-10-08WarningsExact identifier
spl id: 966a85da-5069-4ed6-9648-91937140f1d1
spl set id: c940517a-1353-421f-a3c2-b49538f7764d

Reported adverse events (FAERS/openFDA)#

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