FDA.reportPublic FDA data

Brain Power

Manufacturer
Integra Health International, S.A. de C.V.
Effective date
2015-05-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:06:41

Label at a glance#

ProductBrain Power
Active ingredientSEMECARPUS ANACARDIUM JUICE, ARNICA MONTANA, CALCIUM FLUORIDE, SILYBUM MARIANUM SEED OIL, CINCHONA OFFICINALIS BARK, HERRING SPERM DNA, GINKGO, EGG PHOSPHOLIPIDS, ACHILLEA MILLEFOLIUM, PHOSPHORIC ACID, SACCHAROMYCES CEREVISIAE RNA, SILICON DIOXIDE, ZINC SULFATE HEPTAHYDRATE
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Indications: Temporarily relieves symptoms of general physical weakness and listlessness, including: fatigue; sore muscles & joints; dry skin; absence of sexual desire; occasional sleeplessness.

OTC - PURPOSE SECTION

NDC#: 2728100396

VIVACITY

Energy Medicine with DNA

Homeopathic Fast-Acting Oral Spray

1.0 Fl Oz (30 mL)

Alcohol 9% v/v

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions: Adults only: spray twice under the tongue, three times a day. This bottle contains about a 1 month supply.

WARNINGS SECTION

Warnings: Keep out of reach of children. If pregnant or breast feeding, ask a doctor before using product. Stop use and ask a doctor if symptoms persist more than 3 days, worsen, or if new symptoms occur.

OTHER SAFETY INFORMATION

Tamper Evident Seal: Do not use if seal around neck of bottle is broken or missing. The letters HPUS indicate that ingredients are officially included in the Homeopathic Pharmacopoeia of the United States.

Distributed by SUNWAY BIOTECH, LLC

Oak HIlls CA 92344 U.S.A. info@sunwaybiotech.com

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Equal volumes of each ingredient: Alfalfa 2X HPUS, Aralia Quinquefolia 2X HPUS, Arnica Montana 3X HPUS, Avena Sativa 2X HPUS, DNA 6X HPUS, DNA 12X HPUS, Galium Aparine 3X HPUS, Hypericum Perforatum 200C HPUS, Oleum Animale 6X HPUS, Pituitarium Posterium 8X HPUS, Rhus Toxicodendron 200C HPUS, RNA 6X HPUS, Thuja Occidentalis 30C HPUS.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Alcohol 9% v/v, Glycerin 10% v/v, Purified Water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label imagelabel image

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55138-001-012020-01-31C16284748780-19d75b9d0-44c5-f424-e053-dadaa90a57ce58f0330d-0c16-4505-913d-26cccf42ae99
55138-001-022020-01-31C16284748780-19d75b9d0-44c5-f424-e053-dadaa90a57ce58f0330d-0c16-4505-913d-26cccf42ae99

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55138-001-01Brain Power30 mL in 1 BOTTLE, SPRAYSPRAY302
55138-001-02Brain Power60 mL in 1 BOTTLE, SPRAYSPRAY602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55138-001BRAIN POWER (SEMECARPUS ANACARDIUM JUICE, ARNICA MONTANA, CALCIUM FLUORIDE, SILYBUM MARIANUM SEED, CINCHONA OFFICINALIS BARK, HERRING SPERM DNA, GINKGO, EGG PHOSPHOLIPIDS, ACHILLEA MILLEFOLIUM, PHOSPHORIC ACID, SACCHAROMYCES CEREVISIA RNA, SILICON DIOXIDE, AND ZINC SULPHATE HEPTAHYDRATE) SPRAY [INTEGRA HEALTH INTERNATIONAL, S.A. DE C.V.]2Legacy NDC, 2 package rows20150516_58f0330d-0c16-4505-913d-26cccf42ae99.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACHILLEA MILLEFOLIUMACTIVE INGREDIENT2FXJ6SW4PK2
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZW2
CALCIUM FLUORIDEACTIVE INGREDIENTO3B55K4YKI2
CINCHONA OFFICINALIS BARKACTIVE INGREDIENTS003A158SB2
EGG PHOSPHOLIPIDSACTIVE INGREDIENT1Z74184RGV2
GINKGOACTIVE INGREDIENT19FUJ2C58T2
HERRING SPERM DNAACTIVE INGREDIENT51FI676N6F2
PHOSPHORIC ACIDACTIVE INGREDIENTE4GA8884NN2
SACCHAROMYCES CEREVISIAE RNAACTIVE INGREDIENTJ17GBZ5VGX2
SEMECARPUS ANACARDIUM JUICEACTIVE INGREDIENTY0F0BU8RDU2
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU42
SILYBUM MARIANUM SEED OILACTIVE INGREDIENTNYY23HEN062
ZINC SULFATE HEPTAHYDRATEACTIVE INGREDIENTN57JI2K7WP2
ACHILLEA MILLEFOLIUMACTIVE MOIETY2FXJ6SW4PK2
ARNICA MONTANAACTIVE MOIETYO80TY208ZW2
CINCHONA OFFICINALIS BARKACTIVE MOIETYS003A158SB2
COLLOIDAL SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU42
EGG PHOSPHOLIPIDSACTIVE MOIETY1Z74184RGV2
FLUORIDE IONACTIVE MOIETYQ80VPU408O2
GINKGOACTIVE MOIETY19FUJ2C58T2
HERRING SPERM DNAACTIVE MOIETY51FI676N6F2
PHOSPHORIC ACIDACTIVE MOIETYE4GA8884NN2
SACCHAROMYCES CEREVISIAE RNAACTIVE MOIETYJ17GBZ5VGX2
SEMECARPUS ANACARDIUM JUICEACTIVE MOIETYY0F0BU8RDU2
SILYBUM MARIANUM SEED OILACTIVE MOIETYNYY23HEN062
ZINC CATIONACTIVE MOIETY13S1S8SF372
ALCOHOLINACTIVE INGREDIENT3K9958V90M2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55138-00155138-001-01, 55138-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
SEMECARPUS ANACARDIUM JUICEY0F0BU8RDUACTIB
ARNICA MONTANAO80TY208ZWACTIB
CALCIUM FLUORIDEO3B55K4YKIACTIB
SILYBUM MARIANUM SEED OILNYY23HEN06ACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
HERRING SPERM DNA51FI676N6FACTIB
GINKGO19FUJ2C58TACTIB
EGG PHOSPHOLIPIDS1Z74184RGVACTIB
ACHILLEA MILLEFOLIUM2FXJ6SW4PKACTIB
PHOSPHORIC ACIDE4GA8884NNACTIB
SACCHAROMYCES CEREVISIAE RNAJ17GBZ5VGXACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
ZINC SULFATE HEPTAHYDRATEN57JI2K7WPACTIM
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT

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 3 · 134 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 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
f94f554a-7a96-4039-bd0b-4c7d45d4598c58f0330d-0c16-4505-913d-26cccf42ae992015-05-15WarningsExact identifier
spl id: f94f554a-7a96-4039-bd0b-4c7d45d4598c
spl set id: 58f0330d-0c16-4505-913d-26cccf42ae99

Reported adverse events (FAERS/openFDA)#

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