Sleep Aid

Manufacturer
King Bio Inc.
Effective date
2020-08-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:13:17

Label at a glance#

ProductSleep Aid
Active ingredientACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM FLOWER, ARSENIC TRIOXIDE, AVENA SATIVA FLOWERING TOP, ATROPA BELLADONNA, CAMPHOR (NATURAL), CINCHONA OFFICINALIS BARK, ARABICA COFFEE BEAN, CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT, HYOSCYAMUS NIGER, STRYCHNOS IGNATII SEED, PASSIFLORA INCARNATA FLOWER, PULSATILLA VULGARIS, VALERIAN
Label structure9 sections

Dosage and administration

█ Initially, depress pump until primed. █ Spray one dose directly into mouth. █ Adults: 3 sprays 3 times per day. █ Children ages 6-12: 2 sprays 3 times per day. █ Consult a physician for use in children under 6 years of age. █ Use additionally as needed, up to 6 times per day.

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

HPUS active ingredients

Equal volumes of each ingredient in 10X, 30X, and 1LM potencies

Aconitum napellus, Aesculus hippocastanum, flos, Arsenicum album, Avena sativa, Belladonna, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Ignatia amara, Passiflora incarnata, Pulsatilla, Valeriana officinalis. 

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Bio-Energetically Enhanced™ pure
water, citrus extract* (ascorbic
acid, citric acid, citrus aurantium
amara fruit extract, citrus
aurantium sinensis peel extract,
citrus reticulata fruit extract,
demineralized water, glycerin,
lactic acid), Honeysuckle (Lonicera
japonica), polylysine, Shagbark
Hickory (Carya ovata) Bark
Extract, steviol (Steviol
glycosides).

Directions

DOSAGE & ADMINISTRATION SECTION

█ Initially, depress pump until
primed.
█ Spray one dose directly into
mouth.
█ Adults: 3 sprays 3 times per
day.
█ Children ages 6-12: 2 sprays 3
times per day.
█ Consult a physician for use in
children under 6 years of age.
█ Use additionally as needed, up
to 6 times per day.

Warnings

WARNINGS SECTION

█ Stop use and consult a physician if symptoms worsen or
persist for more than 7 days.


OTC - PREGNANCY OR BREAST FEEDING SECTION

█ If pregnant or breast-feeding, ask a healthcare professional
before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

█ Keep out of reach of children. In case of overdose, get
medical help or contact a Poison Control Center immediately.

Other Information

STORAGE AND HANDLING SECTION

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

Purpose

OTC - PURPOSE SECTION

HPUS active ingredients                   Purpose

Equal volumes of each HPUS** ingredient in 10X, 30X, and 1LM
potencies.

Aconitum napellus...................................fear, worry

Aesculus hippocastanum, flos....................heavy eyelids

Arsenicum album....................................anguish, fears

Avena sativa..........................................nervous exhaustion

Belladonna.............................................restlessness

Camphora.............................................restless tossing

Cinchona officinalis.................................anxious dreams, early waking

Coffea cruda.........................................nervous excitability

Cypripedium pubescens.........................wakefulness

Hyoscyamus niger.................................inability to fall asleep

Ignatia amara.........................................light sleep, worry

Passiflora incarnata................................restlessness, wakefulness

Pulsatilla................................................irregular sleep patterns

Valeriana officinalis................................tossing and turning

**“HPUS” indicates the active ingredients are in the official
Homeopathic Pharmacopeia of the United States.

INDICATIONS & USAGE SECTION

Uses for temporary relief of symptoms due to occasional
sleeplessness: █ restlessness █ nervousness █ exhaustion
█ excitability █ inability to fall or stay asleep █ worry.
† as per various homeopathic materia medicas. Claims based
on traditional homeopathic practice, not accepted medical
evidence. These uses have not been evaluated by the FDA,
and product has not been clinically tested.

OTC - QUESTIONS SECTION

Questions? Call 866.298.2740
King Bio, Inc. • 3 Westside Drive
Asheville, NC 28806 USA
FDA Reg. #1053442

For latest product information and instructions: www.DrKings.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

nm-sleep-aid.jpgnm-sleep-aid.jpg

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
57955-5639-22022-01-28C16284748780-19d75b9d1-084c-f424-e053-dadaa90a57ceSleep Aid
57955-5639-22020-08-20C16284748780-19d75b9d1-084c-f424-e053-dadaa90a57ceSleep Aid
57955-5639-22020-01-31C16284748780-19d75b9d1-084c-f424-e053-dadaa90a57ceSleep Aid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-5639-2Sleep Aid59 mL in 1 BOTTLE, SPRAYLIQUID593
57955-5639-2Sleep Aid1 in 1 BOXLIQUID13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57955-5639SLEEP AID (ACONITUM NAPELLUS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, IGNATIA AMARA, PASSIFLORA INCARNATA, PULSATILLA, VALERIANA OFFICINALIS,AESCULUS HIPPOCASTANUM, FLOS) LIQUID [KING BIO INC.]3Legacy NDC, 2 package rows20200821_57503fe4-0c7c-4d38-bccb-c9bda9bf1e41.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACONITUM NAPELLUSACTIVE INGREDIENTU0NQ8555JD1
AESCULUS HIPPOCASTANUM FLOWERACTIVE INGREDIENTKK0Z92II8M1
ARABICA COFFEE BEANACTIVE INGREDIENT3SW678MX721
ARSENIC TRIOXIDEACTIVE INGREDIENTS7V92P67HO1
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0H1
AVENA SATIVA FLOWERING TOPACTIVE INGREDIENTMA9CQJ3F7F1
CAMPHOR (NATURAL)ACTIVE INGREDIENTN20HL7Q9411
CINCHONA OFFICINALIS BARKACTIVE INGREDIENTS003A158SB1
CYPRIPEDIUM PARVIFOLUM ROOTACTIVE INGREDIENT21Y9GZ1LZA1
HYOSCYAMUS NIGERACTIVE INGREDIENT4WRK2153H31
PASSIFLORA INCARNATA FLOWERACTIVE INGREDIENTK8F3G29S6Z1
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEV1
STRYCHNOS IGNATII SEEDACTIVE INGREDIENT1NM3M2487K1
VALERIANACTIVE INGREDIENTJWF5YAW3QW1
ACONITUM NAPELLUSACTIVE MOIETYU0NQ8555JD1
AESCULUS HIPPOCASTANUM FLOWERACTIVE MOIETYKK0Z92II8M1
ARABICA COFFEE BEANACTIVE MOIETY3SW678MX721
ARSENIC CATION (3+)ACTIVE MOIETYC96613F5AV1
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0H1
AVENA SATIVA FLOWERING TOPACTIVE MOIETYMA9CQJ3F7F1
CAMPHOR (NATURAL)ACTIVE MOIETYN20HL7Q9411
CINCHONA OFFICINALIS BARKACTIVE MOIETYS003A158SB1
CYPRIPEDIUM PARVIFOLUM ROOTACTIVE MOIETY21Y9GZ1LZA1
HYOSCYAMUS NIGERACTIVE MOIETY4WRK2153H31
PASSIFLORA INCARNATA FLOWERACTIVE MOIETYK8F3G29S6Z1
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEV1
STRYCHNOS IGNATII SEEDACTIVE MOIETY1NM3M2487K1
VALERIANACTIVE MOIETYJWF5YAW3QW1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57955-563957955-5639-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

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
ad5425c6-3681-b0f1-e053-2a95a90a3e4257503fe4-0c7c-4d38-bccb-c9bda9bf1e412020-08-20WarningsExact identifier
spl id: ad5425c6-3681-b0f1-e053-2a95a90a3e42
spl set id: 57503fe4-0c7c-4d38-bccb-c9bda9bf1e41

Reported adverse events (FAERS/openFDA)#

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