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Sleep Aid

Sleep Aid

Approved
Approval ID

44daeef5-1e4d-474e-ae60-1131c15e470e

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 19, 2025

Manufacturers
FDA

King Bio Inc.

DUNS: 617901350

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

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

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code57955-5638
Product Classification
G
Generic Name
Aconitum napellus, Aesculus hippocastanum, flos, Arsenicum album, Avena sativa, Belladonna, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Kali phosphoricum, Ignatia amara, Passiflora incarnata, Phosphorus, Pulsatilla, Valeriana officinalis.
Product Specifications
Route of AdministrationORAL
Effective DateMay 19, 2025
FDA Product Classification

INGREDIENTS (28)

ACONITUM NAPELLUS WHOLEActive
Quantity: 10 [hp_X] in 59 mL
Code: U0NQ8555JD
Classification: ACTIB
AESCULUS HIPPOCASTANUM FLOWERActive
Quantity: 10 [hp_X] in 59 mL
Code: KK0Z92II8M
Classification: ACTIB
ARSENIC TRIOXIDEActive
Quantity: 10 [hp_X] in 59 mL
Code: S7V92P67HO
Classification: ACTIB
AVENA SATIVA FLOWERING TOPActive
Quantity: 10 [hp_X] in 59 mL
Code: MA9CQJ3F7F
Classification: ACTIB
ATROPA BELLADONNAActive
Quantity: 10 [hp_X] in 59 mL
Code: WQZ3G9PF0H
Classification: ACTIB
CAMPHOR (NATURAL)Active
Quantity: 10 [hp_X] in 59 mL
Code: N20HL7Q941
Classification: ACTIB
CINCHONA OFFICINALIS BARKActive
Quantity: 10 [hp_X] in 59 mL
Code: S003A158SB
Classification: ACTIB
ARABICA COFFEE BEANActive
Quantity: 10 [hp_X] in 59 mL
Code: 3SW678MX72
Classification: ACTIB
CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOTActive
Quantity: 10 [hp_X] in 59 mL
Code: 21Y9GZ1LZA
Classification: ACTIB
HYOSCYAMUS NIGERActive
Quantity: 10 [hp_X] in 59 mL
Code: 4WRK2153H3
Classification: ACTIB
DIBASIC POTASSIUM PHOSPHATEActive
Quantity: 10 [hp_X] in 59 mL
Code: CI71S98N1Z
Classification: ACTIB
STRYCHNOS IGNATII SEEDActive
Quantity: 10 [hp_X] in 59 mL
Code: 1NM3M2487K
Classification: ACTIB
PHOSPHORUSActive
Quantity: 10 [hp_X] in 59 mL
Code: 27YLU75U4W
Classification: ACTIB
PULSATILLA VULGARIS WHOLEActive
Quantity: 10 [hp_X] in 59 mL
Code: I76KB35JEV
Classification: ACTIB
VALERIANActive
Quantity: 10 [hp_X] in 59 mL
Code: JWF5YAW3QW
Classification: ACTIB
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
CITRUS AURANTIUM FRUIT OILInactive
Code: 59JDQ5VT0T
Classification: IACT
ORANGE PEELInactive
Code: TI9T76XD44
Classification: IACT
CITRUS RETICULATA FRUIT OILInactive
Code: 25P9H3QU5E
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5AT
Classification: IACT
LONICERA JAPONICA FLOWERInactive
Code: 4465L2WS4Y
Classification: IACT
POLYEPSILON-LYSINE (4000 MW)Inactive
Code: WB0M8X4TWR
Classification: IACT
CARYA OVATA BARKInactive
Code: X765CF609L
Classification: IACT
STEVIOLInactive
Code: 4741LYX6RT
Classification: IACT
PASSIFLORA INCARNATA FLOWERING TOPActive
Quantity: 10 [hp_X] in 59 mL
Code: CLF5YFS11O
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 12/7/2022

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 12/7/2022

Uses

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.

Reference image:Sleep .jpg

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 12/7/2022

Directions

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.

Reference image:Sleep .jpg

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 12/7/2022

Other information

Tamper resistant for your protection.

Use only if safety seal is intact.

Keep carton for complete drug facts and product information.

Questions? Call 866.298.2740

King Bio, Inc. 3 Westside Drive

Asheville, NC 2806 USA

FDA Reg. #1053442

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

Reference image:Sleep .jpg

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 12/7/2022

Inactive Ingredients

Citrus Extract (ascorbic acid, citric acid, citrus aurantium amara fruit extract, citrus aurantium sinensis peel extract, citrus reticulata fruit extact, demineralized water, glycerin, lactic acid), Honeysuckle (Lonicera japonica), Polylysine, Purified Water, Shagbark Hickory (Carya Ovata) Bark Extract, Steviol (Steviol Glycosides).

Reference image:Sleep .jpg

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 12/7/2022

Active ingredients

Equal volumes of each HPUS** 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, Kali phosphoricum, Ignatia amara, Passiflora incarnata, Phosphorus,
Pulsatilla, Valeriana officinalis.

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

Reference image:Sleep .jpg

WARNINGS SECTION

LOINC: 34071-1Updated: 12/7/2022

Warnings

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

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

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center immediately.

Reference image:Sleep .jpg

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 12/7/2022

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center immediately.

Reference image:Sleep .jpg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 12/7/2022

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
Kali phosphoricum...................................................night terrors
Ignatia amara ..................................................light sleep, worry
Passiflora incarnata................................restlessness, wakefulness
Phosphorus ...........................................................sleeplessness
Pulsatilla .................................................irregular sleep patterns
Valeriana officinalis..........................................tossing and turning

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

Reference image:Sleep .jpg

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Sleep Aid - FDA Drug Approval Details