FDA.reportPublic FDA data

DRUG FACTS:

Manufacturer
BioActive Nutritional, Inc | Apotheca Company
Effective date
2026-06-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-06-11 05:11:11

Label at a glance#

ProductHZ Formula
Active ingredientBAPTISIA TINCTORIA WHOLE, ECHINACEA ANGUSTIFOLIA WHOLE, LOMATIUM DISSECTUM ROOT, TABEBUIA IMPETIGINOSA BARK, PROPOLIS WAX, SUS SCROFA SPLEEN, SUS SCROFA THYMUS, THYROID, GELSEMIUM SEMPERVIRENS ROOT, LYCOPODIUM CLAVATUM SPORE, STRYCHNOS NUX-VOMICA SEED, CHLAMYDIA TRACHOMATIS, HUMAN HERPESVIRUS 1, HUMAN HERPESVIRUS 2, CANDIDA ALBICANS, HUMAN PAPILLOMAVIRUS, TRICHINELLA SPIRALIS
Label structure9 sections

Indications and uses

For temporary relief of weakness, exhaustion, vertigo, and difficult mental concentration.** **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

Baptisia Tinctoria 3X, Candida Albicans 30X, 60X, 200X, Chlamydia Trachomatis 30X, 60X, 200X, Echinacea (Angustifolia) 3X, Gelsemium Sempervirens 12X, Herpes Simplex 1 & 2 Nodose 30X, 60X, 200X, Human Papillomavirus 30X, 60X, 200X, Lomatium Dissectum 3X, Lycopodium Clavatum 12X, Nux Vomica 12X, Propolis 6X, Spleen (Suis) 6X, Tabebuia Impetiginosa 3X, Thymus (Suis) 6X, Thyroidinum (Suis) 6X, Trichinella Spiralis 30X, 60X, 200X.

PURPOSE:

OTC - PURPOSE SECTION

Baptisia Tinctoria – flu-like symptoms,** Candida Albicans – throat pain,** Chlamydia Trachomatis - fever,** Echinacea (Angustifolia) - exhaustion,** Gelsemium Sempervirens - fever,** Herpes Simplex 1 & 2 Nodose – cold sores,** Human Papillomavirus - fatigue,** Lomatium Dissectum - malaise,** Lycopodium Clavatum – skin irritation,** Nux Vomica - fatigue,** Propolis – nerve pain,** Spleen (Suis) - weakness,** Tabebuia Impetiginosa - fever,** Thymus (Suis) - burning,** Thyroidinum (Suis) - itching,** Trichinella Spiralis – fatigue**

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

USES:

INDICATIONS & USAGE SECTION

For temporary relief of weakness, exhaustion, vertigo, and difficult mental concentration.**

**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

HZ FORMULA

HOMEOPATHIC

1 fl. oz. (30 mL)

HZ FORMULAHZ FORMULA

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130210184341268GTIN-13: 0210184341268
EAN-13: 0210184341268
GTIN-12: 210184341268
UPC-A: 210184341268
GTIN storage (14 digits): 00210184341268		BANI0100 HZ-Formula 3-20-26.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0313-12024-08-29C16284748780-11030e365-44f6-111a-e063-dadaa90a10e2DRUG FACTS:
43857-0313-12024-08-29C16284748780-11030e365-44f6-111a-e063-dadaa90a10e2DRUG FACTS:
43857-0313-12024-01-30C16284748780-11030e365-44f6-111a-e063-dadaa90a10e2DRUG FACTS:
43857-0313-12024-01-30C16284748780-11030e365-44f6-111a-e063-dadaa90a10e2DRUG FACTS:

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BAPTISIA TINCTORIAACTIVE INGREDIENT5K1UO2888Y1
CANDIDA ALBICANSACTIVE INGREDIENT4D7G21HDBC1
CHLAMYDIA TRACHOMATISACTIVE INGREDIENTT6NI39QU441
ECHINACEA ANGUSTIFOLIAACTIVE INGREDIENTVB06AV5US81
GELSEMIUM SEMPERVIRENS ROOTACTIVE INGREDIENT639KR60Q1Q1
HUMAN HERPESVIRUS 1ACTIVE INGREDIENT22G38P19RL1
HUMAN HERPESVIRUS 2ACTIVE INGREDIENT74J6DNH49U1
HUMAN PAPILLOMAVIRUSACTIVE INGREDIENT23CVL7WF4J1
LOMATIUM DISSECTUM ROOTACTIVE INGREDIENT5329928G5N1
LYCOPODIUM CLAVATUM SPOREACTIVE INGREDIENTC88X29Y4791
PROPOLIS WAXACTIVE INGREDIENT6Y8XYV2NOF1
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH139191
SUS SCROFA SPLEENACTIVE INGREDIENT92AMN5J79Y1
SUS SCROFA THYMUSACTIVE INGREDIENT7B69B0BD621
TABEBUIA IMPETIGINOSA BARKACTIVE INGREDIENT6GLA1946WX1
THYROID, PORCINEACTIVE INGREDIENT6RV024OAUQ1
TRICHINELLA SPIRALISACTIVE INGREDIENT2PYI6D7HCQ1
BAPTISIA TINCTORIAACTIVE MOIETY5K1UO2888Y1
CANDIDA ALBICANSACTIVE MOIETY4D7G21HDBC1
CHLAMYDIA TRACHOMATISACTIVE MOIETYT6NI39QU441
ECHINACEA ANGUSTIFOLIAACTIVE MOIETYVB06AV5US81
GELSEMIUM SEMPERVIRENS ROOTACTIVE MOIETY639KR60Q1Q1
HUMAN HERPESVIRUS 1ACTIVE MOIETY22G38P19RL1
HUMAN HERPESVIRUS 2ACTIVE MOIETY74J6DNH49U1
HUMAN PAPILLOMAVIRUSACTIVE MOIETY23CVL7WF4J1
LOMATIUM DISSECTUM ROOTACTIVE MOIETY5329928G5N1
LYCOPODIUM CLAVATUM SPOREACTIVE MOIETYC88X29Y4791
PROPOLIS WAXACTIVE MOIETY6Y8XYV2NOF1
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH139191
SUS SCROFA SPLEENACTIVE MOIETY92AMN5J79Y1
SUS SCROFA THYMUSACTIVE MOIETY7B69B0BD621
SUS SCROFA THYROIDACTIVE MOIETY6RV024OAUQ1
TABEBUIA IMPETIGINOSA BARKACTIVE MOIETY6GLA1946WX1
TRICHINELLA SPIRALISACTIVE MOIETY2PYI6D7HCQ1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-031343857-0313-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
BAPTISIA TINCTORIA WHOLE5K1UO2888YACTIB
ECHINACEA ANGUSTIFOLIA WHOLEVB06AV5US8ACTIB
LOMATIUM DISSECTUM ROOT5329928G5NACTIB
TABEBUIA IMPETIGINOSA BARK6GLA1946WXACTIB
PROPOLIS WAX6Y8XYV2NOFACTIB
SUS SCROFA SPLEEN92AMN5J79YACTIB
SUS SCROFA THYMUS7B69B0BD62ACTIB
THYROID6RV024OAUQACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
CHLAMYDIA TRACHOMATIST6NI39QU44ACTIB
HUMAN HERPESVIRUS 122G38P19RLACTIB
HUMAN HERPESVIRUS 274J6DNH49UACTIB
CANDIDA ALBICANS4D7G21HDBCACTIB
HUMAN PAPILLOMAVIRUS23CVL7WF4JACTIB
TRICHINELLA SPIRALIS2PYI6D7HCQACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42024-08-29full-release2026-06-01 02:27:51

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
HZ FormulaBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, PROPOLIS, SPLEEN (SUIS), THYMUS (SUIS), THROIDINUM (SUIS), GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, NUX VOMICA, CHLAMYDIA TRACHOMATIS, HERPES SIMPLEX 1 NOSODE, HERPES SIMPLEX 2 NOSODE, CANDIDA ALBICANS, HUMAN PAPILLOMAVIRUS, TRICHINELLA SPIRALISBioActive Nutritional, Inc3929188d-99bc-497f-bac7-3493bd58d2f72026-06-08WarningsExact identifier
ndc (package): 43857-0313-1
ndc (product): 43857-0313
ndc11 (package): 43857031301
spl id: 0e2c8a1d-b1b3-494c-b96a-1346250af55d
spl set id: 3929188d-99bc-497f-bac7-3493bd58d2f7

Reported adverse events (FAERS/openFDA)#

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