Sleep Eezzz

Manufacturer: New Sun Inc.
Effective date: 2014-07-30
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:05:52

Label at a glance#

ProductSleep Eezzz

Active ingredientACONITUM NAPELLUS, ARSENIC TRIOXIDE, AVENA SATIVA FLOWERING TOP, ATROPA BELLADONNA, CAMPHOR (NATURAL), CINCHONA OFFICINALIS BARK, ARABICA COFFEE BEAN, CYPRIPEDIUM PARVIFOLUM ROOT, HYOSCYAMUS NIGER, PASSIFLORA INCARNATA FLOWERING TOP, PULSATILLA VULGARIS, VALERIAN

Label structure9 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Directions: Before initial dose depress pump 4-5 times or until primed and spray 1 dose directly in mouth 4 to 6 times daily until symptoms improve.

Adult Dose: 3 Pump Sprays

Child's Dose: (2-12): 2 Pump Sprays

Infants-2 yrs: 1 Pump Spray

WARNINGS SECTION

Warnings: If symptoms persist or worsen, seek advice of physician. If pregnant or breast-feeding, take only on advice of physician.

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.

OTC - PURPOSE SECTION

Indications: For temporary relief of: •restlessness •inability to fall asleep •sleeplessness •tossing & turning •light sleeping •overactive mind •tension/anxiety •disturbed sleep •unrefreshing sleep •nightly itching & muscular spasms

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Aconitum napellus, Arsenicum album, Avena sativa, Belladonna, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Passiflora incarnata, Pulsatilla, Valeriana officinalis. Equal volumes of each ingredient in 10X, 30X, and 100X potencies.

INACTIVE INGREDIENT SECTION

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

INDICATIONS & USAGE SECTION

Indications: For temporary relief of: restlessness •inability to fall asleep •sleeplessness •tossing & turning •light sleeping •overactive mind •tension/anxiety •disturbed sleep •unrefreshing sleep •nightly itching & muscular spasms

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139	Product name	3	20240506
e5a77e9c-c528-733a-173d-914a234c024b	Product name	5	20240506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66579-0009-2	2020-01-31	C162847	48780-1	9d75b9cf-ef78-f424-e053-dadaa90a57ce	Sleep Eezzz

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66579-0009-2	Sleep Eezzz	59 mL in 1 BOTTLE, SPRAY	LIQUID	59		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66579-0009	SLEEP EEZZZ (ACONITUM NAPELLUS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, PASSIFLORA INCARNATA, PULSATILLA, VALERIANA OFFICINALIS) LIQUID [NEW SUN INC.]	1	Legacy NDC, 1 package rows	20140730_25fc2303-8e04-476e-b407-d8abea37068b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ACONITUM NAPELLUS	ACTIVE INGREDIENT	U0NQ8555JD	1
ARABICA COFFEE BEAN	ACTIVE INGREDIENT	3SW678MX72	1
ARSENIC TRIOXIDE	ACTIVE INGREDIENT	S7V92P67HO	1
ATROPA BELLADONNA	ACTIVE INGREDIENT	WQZ3G9PF0H	1
AVENA SATIVA FLOWERING TOP	ACTIVE INGREDIENT	MA9CQJ3F7F	1
CAMPHOR (NATURAL)	ACTIVE INGREDIENT	N20HL7Q941	1
CINCHONA OFFICINALIS BARK	ACTIVE INGREDIENT	S003A158SB	1
CYPRIPEDIUM PARVIFOLUM ROOT	ACTIVE INGREDIENT	21Y9GZ1LZA	1
HYOSCYAMUS NIGER	ACTIVE INGREDIENT	4WRK2153H3	1
PASSIFLORA INCARNATA FLOWERING TOP	ACTIVE INGREDIENT	CLF5YFS11O	1
PULSATILLA VULGARIS	ACTIVE INGREDIENT	I76KB35JEV	1
VALERIAN	ACTIVE INGREDIENT	JWF5YAW3QW	1
ACONITUM NAPELLUS	ACTIVE MOIETY	U0NQ8555JD	1
ARABICA COFFEE BEAN	ACTIVE MOIETY	3SW678MX72	1
ARSENIC CATION (3+)	ACTIVE MOIETY	C96613F5AV	1
ATROPA BELLADONNA	ACTIVE MOIETY	WQZ3G9PF0H	1
AVENA SATIVA FLOWERING TOP	ACTIVE MOIETY	MA9CQJ3F7F	1
CAMPHOR (NATURAL)	ACTIVE MOIETY	N20HL7Q941	1
CINCHONA OFFICINALIS BARK	ACTIVE MOIETY	S003A158SB	1
CYPRIPEDIUM PARVIFOLUM ROOT	ACTIVE MOIETY	21Y9GZ1LZA	1
HYOSCYAMUS NIGER	ACTIVE MOIETY	4WRK2153H3	1
PASSIFLORA INCARNATA FLOWERING TOP	ACTIVE MOIETY	CLF5YFS11O	1
PULSATILLA VULGARIS	ACTIVE MOIETY	I76KB35JEV	1
VALERIAN	ACTIVE MOIETY	JWF5YAW3QW	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

Sleep Eezzz
Aconitum napellus, Arsenicum album, Avena sativa, Belladonna, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Passiflora incarnata, Pulsatilla, Valeriana officinalis
ACONITUM NAPELLUS
ARSENIC TRIOXIDE
ARSENIC CATION (3+)
AVENA SATIVA FLOWERING TOP
ATROPA BELLADONNA
CAMPHOR (NATURAL)
CINCHONA OFFICINALIS BARK
ARABICA COFFEE BEAN
CYPRIPEDIUM PARVIFOLUM ROOT
HYOSCYAMUS NIGER
PASSIFLORA INCARNATA FLOWERING TOP
PULSATILLA VULGARIS
VALERIAN
CITRIC ACID MONOHYDRATE
POTASSIUM SORBATE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
66579-0009	66579-0009-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACONITUM NAPELLUS	U0NQ8555JD	ACTIB
ARSENIC TRIOXIDE	S7V92P67HO	ACTIB
AVENA SATIVA FLOWERING TOP	MA9CQJ3F7F	ACTIB
ATROPA BELLADONNA	WQZ3G9PF0H	ACTIB
CAMPHOR (NATURAL)	N20HL7Q941	ACTIB
CINCHONA OFFICINALIS BARK	S003A158SB	ACTIB
ARABICA COFFEE BEAN	3SW678MX72	ACTIB
CYPRIPEDIUM PARVIFOLUM ROOT	21Y9GZ1LZA	ACTIB
HYOSCYAMUS NIGER	4WRK2153H3	ACTIB
PASSIFLORA INCARNATA FLOWERING TOP	CLF5YFS11O	ACTIB
PULSATILLA VULGARIS	I76KB35JEV	ACTIB
VALERIAN	JWF5YAW3QW	ACTIB
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 107 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SHAMPOO / TOPICAL		17 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRAPLEURAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION / RECTAL	6.67 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	AEROSOL, FOAM / RECTAL		7 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / SUBCUTANEOUS		28 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	DOUCHE / VAGINAL	0.07 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION/ DROPS / AURICULAR (OTIC)	0.04 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, EXTENDED RELEASE / ORAL		45 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / SUBCUTANEOUS		26 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CAPSULE / ORAL		238 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SYRUP / ORAL	2 mg/1ml		Exact identifier — unii candidate 19 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INFILTRATION	0.02 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / INTRAVENOUS		10 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION/ DROPS / ORAL		19 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET / SUBLINGUAL		24 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / BUCCAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	EMULSION / OPHTHALMIC	0.47 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	LOTION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 19 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INHALANT / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION / ORAL	1000 mg/15ml		Exact identifier — unii candidate 19 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / INTRAVENOUS		396 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	EMULSION / TOPICAL	0.11 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	FILM / SUBLINGUAL		10 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / PERIDURAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	GEL / TOPICAL		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	AEROSOL, FOAM / TOPICAL		8 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CAPSULE, EXTENDED RELEASE / ORAL		101 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION, CONCENTRATE / IRRIGATION		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER, FOR SOLUTION / ORAL		315 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		38 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SPRAY / NASAL		9 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION, EXTENDED RELEASE / ORAL	140.8 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, CHEWABLE / ORAL	7 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LOTION / TOPICAL	0.85 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER / ORAL		840 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SPRAY, METERED / NASAL	0.06 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	CONCENTRATE / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / INTRAMUSCULAR		26 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	DROPS / ORAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TROCHE / ORAL	12 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	POWDER, FOR SUSPENSION / ORAL		19 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / RESPIRATORY (INHALATION)		8 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET / ORAL	914 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SPRAY, METERED / NASAL		2 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION / RESPIRATORY (INHALATION)	0.03 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / INTRAVENOUS	0.2 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	0.2 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / EPIDURAL	0.02 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET / ORAL		6 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SHAMPOO, SUSPENSION / TOPICAL	0.25 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CONCENTRATE / ORAL	5.3 mg/1ml		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION/ DROPS / TOPICAL	0.01 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / AURICULAR (OTIC)	0.2 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CREAM / VAGINAL	0.49 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 88 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
90c87a4a-c448-4bcd-96d0-043842fe68b3			25fc2303-8e04-476e-b407-d8abea37068b	2014-07-30	Warnings	Exact identifier spl id: 90c87a4a-c448-4bcd-96d0-043842fe68b3 spl set id: 25fc2303-8e04-476e-b407-d8abea37068b

Reported adverse events (FAERS/openFDA)#

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