FDA.reportPublic FDA data

Vitalizer

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2023-04-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:20:45

Label at a glance#

ProductVitalizer
Active ingredientECHINACEA ANGUSTIFOLIA WHOLE, IODINE, ARSENIC TRIOXIDE, GOLD, CALCIUM FLUORIDE, GALLIC ACID MONOHYDRATE, HEKLA LAVA, NICKEL SULFATE HEXAHYDRATE, PHOSPHORUS, SEDUM ACRE WHOLE, SEMPERVIVUM TECTORUM LEAF, PACKERA AUREA WHOLE, PERIPLANETA AMERICANA, ONOSMODIUM VIRGINIANUM
Label structure9 sections

Dosage and administration

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Echinacea 3X, Iodium 6X, Arsenicum Album 12X, Aurum Metallicum 12X, Calcarea Fluorica 12X, Gallicum Acidum 12X, Hekla Lava 12X, Niccolum Sulphuricum 12X, Phosphorus 12X, Sedum Acre 12X, Sempervivum Tectorum 12X, Senecio Aureus 12X, Blatta Americana 16X, Onosmodium Virginianum 30C.

PURPOSE:

OTC - PURPOSE SECTION

For temporary relief of fatigue, weakness after exhausting diseases, headaches and sensitivity to light and noise.

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 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. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

For temporary relief of fatigue, weakness after exhausting diseases, headaches and sensitivity to light and noise.

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

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional

VITALIZER

HOMEOPATHIC

1 FL OZ (30 ml)

VITALIZERVITALIZER

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0629-1Vitalizer30 mL in 1 BOTTLE, DROPPERLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0629VITALIZER (ECHINACEA (ANGUSTIFOLIA), IODIUM, ARSENICUM ALBUM, AURUM METALLICUM, CALCAREA FLUORICA, GALLICUM ACIDUM, HEKLA LAVA, NICCOLUM SULPHURICUM, PHOSPHORUS, SEDUM ACRE, SEMPERVIVUM TECTORUM, SENECIO AUREUS, BLATTA AMERICANA, ONOSMODIUM VIRGINIANUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1Current NDC, 1 package rows20230407_a643abc6-5367-4b34-848a-83bdb6ddd87d.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-062943857-0629-1

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
ECHINACEA ANGUSTIFOLIA WHOLEVB06AV5US8ACTIB
IODINE9679TC07X4ACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
GOLD79Y1949PYOACTIB
CALCIUM FLUORIDEO3B55K4YKIACTIB
GALLIC ACID MONOHYDRATE48339473OTACTIB
HEKLA LAVAC21158IIRKACTIB
NICKEL SULFATE HEXAHYDRATEJC9WZ4FK68ACTIB
PHOSPHORUS27YLU75U4WACTIB
SEDUM ACRE WHOLE2496VW6S9JACTIB
SEMPERVIVUM TECTORUM LEAF3DGJ7BUA01ACTIB
PACKERA AUREA WHOLE5WS1632J8WACTIB
PERIPLANETA AMERICANA2RQ1L9N089ACTIB
ONOSMODIUM VIRGINIANUM604NK4250SACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

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
VitalizerECHINACEA (ANGUSTIFOLIA), IODIUM, ARSENICUM ALBUM, AURUM METALLICUM, CALCAREA FLUORICA, GALLICUM ACIDUM, HEKLA LAVA, NICCOLUM SULPHURICUM, PHOSPHORUS, SEDUM ACRE, SEMPERVIVUM TECTORUM, SENECIO AUREUS, BLATTA AMERICANA, ONOSMODIUM VIRGINIANUMBioActive Nutritional, Inc.a643abc6-5367-4b34-848a-83bdb6ddd87d2023-04-06WarningsExact identifier
ndc (package): 43857-0629-1
ndc (product): 43857-0629
ndc11 (package): 43857062901
spl id: ec54a5b1-a400-4022-8452-cbb85f0396c3
spl set id: a643abc6-5367-4b34-848a-83bdb6ddd87d

Reported adverse events (FAERS/openFDA)#

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