FDA.reportPublic FDA data

DRUG FACTS:

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2026-06-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-06-11 05:10:14

Label at a glance#

ProductInsomnia HP
Active ingredientARSENIC TRIOXIDE, ARABICA COFFEE BEAN, POTASSIUM CARBONATE, MAGNESIUM CARBONATE, STRYCHNOS NUX-VOMICA SEED, PASSIFLORA INCARNATA FLOWERING TOP, SEPIA OFFICINALIS JUICE, VALERIAN
Label structure9 sections

Indications and uses

For temporary relief of sleeplessness.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Dosage and administration

• 10 drops orally, 3 times a day or as directed by a health care professional. • Consult a health care professional for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Arsenicum Album 30X, Coffea Cruda 30X, Kali Carbonicum 30X, Magnesia Carbonica 30X, Nux Vomica 30X, Passiflora Incarnata 30X, Sepia 30X, Valeriana Officinalis 30X.

PURPOSE:

OTC - PURPOSE SECTION

Arsenicum Album - restlessness,** Coffea Cruda - sleeplessness,** Kali Carbonicum - fatigue,** Magnesia Carbonica – trouble sleeping,** Nux Vomica - fatigue,** Passiflora Incarnata - insomnia,** Sepia - fatigue,** Valeriana Officinalis – sleeplessness**

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

USES:

INDICATIONS & USAGE SECTION

For temporary relief of sleeplessness.**

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

WARNINGS:

WARNINGS SECTION

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

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

Do not use if tamper evident seal is broken or missing.

Store in a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

• 10 drops orally, 3 times a day or as directed by a health care professional.

• Consult a health care professional for use in children under 12 years of age.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com

1-800-288-9525

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional

INSOMNIA HP

HOMEOPATHIC

1 fl. oz. (30 mL)

INSOMNIA HPINSOMNIA HP

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130210184341862GTIN-13: 0210184341862
EAN-13: 0210184341862
GTIN-12: 210184341862
UPC-A: 210184341862
GTIN storage (14 digits): 00210184341862		BANI0134 Insomnia HP 03-12-26.jpg

DailyMed Product Concepts#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARABICA COFFEE BEANACTIVE INGREDIENT3SW678MX721
ARSENIC TRIOXIDEACTIVE INGREDIENTS7V92P67HO1
MAGNESIUM CARBONATEACTIVE INGREDIENT0E53J927NA1
PASSIFLORA INCARNATA FLOWERING TOPACTIVE INGREDIENTCLF5YFS11O1
POTASSIUM CARBONATEACTIVE INGREDIENTBQN1B9B9HA1
SEPIA OFFICINALIS JUICEACTIVE INGREDIENTQDL83WN8C21
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH139191
VALERIANACTIVE INGREDIENTJWF5YAW3QW1
ARABICA COFFEE BEANACTIVE MOIETY3SW678MX721
ARSENIC CATION (3+)ACTIVE MOIETYC96613F5AV1
CARBONATE IONACTIVE MOIETY7UJQ5OPE7D1
PASSIFLORA INCARNATA FLOWERING TOPACTIVE MOIETYCLF5YFS11O1
SEPIA OFFICINALIS JUICEACTIVE MOIETYQDL83WN8C21
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH139191
VALERIANACTIVE MOIETYJWF5YAW3QW1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-014243857-0142-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARSENIC TRIOXIDES7V92P67HOACTIB
ARABICA COFFEE BEAN3SW678MX72ACTIB
POTASSIUM CARBONATEBQN1B9B9HAACTIB
MAGNESIUM CARBONATE0E53J927NAACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PASSIFLORA INCARNATA FLOWERING TOPCLF5YFS11OACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
VALERIANJWF5YAW3QWACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22016-12-20full-release2026-06-01 02:08:25

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 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Insomnia HPARSENICUM ALBUM, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALISBioActive Nutritional, Inc.cd17b39e-6531-407d-8007-8cb92a6e87442026-06-04WarningsExact identifier
ndc (package): 43857-0142-1
ndc (product): 43857-0142
ndc11 (package): 43857014201
spl id: 5c8e2123-ae52-4bb4-9e3c-18cb01b74196
spl set id: cd17b39e-6531-407d-8007-8cb92a6e8744

Reported adverse events (FAERS/openFDA)#

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