FDA.reportPublic FDA data

Harmony Slumber

Manufacturer
Life Harmony Energies, LLC. | King Bio Inc.
Effective date
2016-03-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:07:32

Label at a glance#

ProductHarmony Slumber
Active ingredientAVENA SATIVA FLOWERING TOP, MATRICARIA RECUTITA, CYPRIPEDIUM PARVIFOLUM ROOT, DAPHNE ODORA BARK, HOPS, HYOSCYAMUS NIGER, POTASSIUM BROMIDE, POTASSIUM PHOSPHATE, DIBASIC, LITHIUM CHLORIDE, PASSIFLORA INCARNATA FLOWERING TOP, SCUTELLARIA LATERIFLORA, DATURA STRAMONIUM, AMBER, FERULA SUMBUL ROOT, VALERIAN, ZANTHOXYLUM AMERICANUM BARK, FERROSOFERRIC PHOSPHATE, EGG PHOSPHOLIPIDS, MANGANESE PHOSPHATE, DIBASIC, ARSENIC TRIOXIDE, ARABICA COFFEE BEAN, STRYCHNOS IGNATII SEED, NUTMEG, AMANITA MUSCARIA FRUITING BODY, ATROPA BELLADONNA, ANAMIRTA COCCULUS SEED, HELLEBORUS NIGER ROOT, ABRUS PRECATORIUS SEED, MELISSA OFFICINALIS, VIBURNUM OPULUS BARK
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Avena sativa, Chamomilla, Cypripedium pubescens, Daphne indica, Humulus lupulus, Hyoscyamus niger, Kali bromatum, Kali phosphoricum, Lithium muriaticum, Passiflora incarnata, Scutellaria lateriflora, Stramonium, Succinum, Sumbul, Valeriana officinalis, Xanthoxylum fraxineum at a 6X potency. Ferrum phosphoricum, Lecithin, Manganum phosphoricum at a 8X potency. Arsenicum album, Coffea cruda, Ignatia amara at a 30X potency. Nux moschata at 4C potency. Agaricus muscarius, Belladonna, Cocculus indicus, Helleborus niger, Jequirity, Melissa officinalis, Viburnum opulus at a 6C potency. Equal volumes of each ingredient.

INACTIVE INGREDIENT SECTION

Inactive Ingredient: Energetic mineralized water (magnesium, potassium). ethanol 13%(v/v). glycerin 8%(v/v).

WARNINGS SECTION

Warnings:If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Stop use and ask your doctor if symptoms persist or worsen. Store in a cool, dry place.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTHER SAFETY INFORMATION

Other information: Tamper resistant for your protection. Use only if safety seal is intact.

*This product has not been clinically tested. Homeopathic provings for each HPUS ingredient are found in various materia medicas referenced in the FDA Compliance Policy Guide.

To reorder please visit: www.EnergeticElixirs.com

Dist. by:

Life Harmony Energies, LLC

1905 Lehigh St. Boulder, CO 80305

service@lifeharmonyenergies.com

OTC - PURPOSE SECTION

Indications: ​A natural aid for falling asleep and sleeping through the night. Helps to restore and balance sleep cycle.

DOSAGE & ADMINISTRATION SECTION

Directions: Adults and children over 12 years of age use 4 to 8 sprays orally at bedtime. May take another dose during the night upon waking prematurely.

INDICATIONS & USAGE SECTION

Indications: ​•​​A natural aid for falling asleep and sleeping through the night. •Helps to restore and balance sleep cycle.

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
b3053bb1-353b-4a0b-bca5-28fe7228957cProduct name220250124
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
8ce6e144-236f-b7be-f690-f06e0c8c6bd3Product name220170725
f09af6ee-c6dd-d0ce-77ad-93508bcdacedProduct name420161205
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
69631-0001-22020-01-31C16284748780-19d75b9d0-31ba-f424-e053-dadaa90a57ceHarmony Slumber

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69631-0001-2Harmony Slumber60 mL in 1 BOTTLE, SPRAYLIQUID601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69631-0001HARMONY SLUMBER (AVENA SATIVA, CHAMOMILLA, CYPRIPEDIUM PUBESCENS, DAPHNE INDICA, HUMULUS LUPULUS, HYOSCYAMUS NIGER, KALI BROMATUM, KALI PHOSPHORICUM, LITHIUM MURIATICUM, PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, STRAMONIUM, SUCCINUM, SUMBUL, VALERIANA OFFICINALIS, XANTHOXYLUM FRAXINEUM, FERRUM PHOSPHORICUM, LECITHIN, MANGANUM PHOSPHORICUM, ARSENICUM ALBUM, COFFEA CRUDA, IGNATIA AMARA, NUX MOSCHATA, AGARICUS MUSCARIUS, BELLADONNA, COCCULUS INDICUS, HELLEBORUS NIGER, JEQUIRITY, MELISSA OFFICINALIS, VIBURNUM OPULUS) LIQUID [LIFE HARMONY ENERGIES, LLC.]1Legacy NDC, 1 package rows20160304_7553ccad-c798-4430-8179-9b908eaceea1.zip

Products#

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

DailyMed product names page 1 of 2 · 42 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69631-000169631-0001-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVENA SATIVA FLOWERING TOPMA9CQJ3F7FACTIB
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
CYPRIPEDIUM PARVIFOLUM ROOT21Y9GZ1LZAACTIB
DAPHNE ODORA BARKJSJ34YQJ5DACTIB
HOPS01G73H6H83ACTIB
HYOSCYAMUS NIGER4WRK2153H3ACTIB
POTASSIUM BROMIDEOSD78555ZMACTIB
POTASSIUM PHOSPHATE, DIBASICCI71S98N1ZACTIB
LITHIUM CHLORIDEG4962QA067ACTIB
PASSIFLORA INCARNATA FLOWERING TOPCLF5YFS11OACTIB
SCUTELLARIA LATERIFLORA7BP4DH5PDCACTIB
DATURA STRAMONIUMG6W4F0V8Z3ACTIB
AMBER70J9Z0J26PACTIB
FERULA SUMBUL ROOTGLA4808EHQACTIB
VALERIANJWF5YAW3QWACTIB
ZANTHOXYLUM AMERICANUM BARKA4KL1HMZ7TACTIB
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB
EGG PHOSPHOLIPIDS1Z74184RGVACTIB
MANGANESE PHOSPHATE, DIBASICVZ3U1H7Q5BACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
ARABICA COFFEE BEAN3SW678MX72ACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
NUTMEGAEE24M3MQ9ACTIB
AMANITA MUSCARIA FRUITING BODYDIF093I037ACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
ANAMIRTA COCCULUS SEED810258W28UACTIB
HELLEBORUS NIGER ROOT608DGJ6815ACTIB
ABRUS PRECATORIUS SEED3OM8I6L7CDACTIB
MELISSA OFFICINALISYF70189L0NACTIB
VIBURNUM OPULUS BARKT1UG6H6805ACTIB
WATER059QF0KO0RIACT
MAGNESIUMI38ZP9992AIACT
POTASSIUMRWP5GA015DIACT
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT

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
5e15748d-a92f-4ea0-a21f-a58e2424b1ac7553ccad-c798-4430-8179-9b908eaceea12016-03-04WarningsExact identifier
spl id: 5e15748d-a92f-4ea0-a21f-a58e2424b1ac
spl set id: 7553ccad-c798-4430-8179-9b908eaceea1

Reported adverse events (FAERS/openFDA)#

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