FDA.reportPublic FDA data

Gynetox

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2024-10-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:28:15

Label at a glance#

ProductGynetox
Active ingredientANGELICA ARCHANGELICA ROOT, BLACK COHOSH, ZINC GLUCONATE, SUS SCROFA UMBILICAL CORD, SUS SCROFA LYMPH, SUS SCROFA OVARY, SUS SCROFA UTERUS, SUS SCROFA ADRENAL GLAND, THYROID, BORIC ACID, WOOD CREOSOTE, MERCURIUS SOLUBILIS, PULSATILLA VULGARIS WHOLE, SEPIA OFFICINALIS JUICE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, PHOSPHORUS, JUNIPERUS SABINA LEAFY TWIG, CANDIDA ALBICANS, HUMAN HERPESVIRUS 1, HUMAN HERPESVIRUS 2, HUMAN PAPILLOMAVIRUS
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

Angelica Archangelica, Cimicifuga Racemosa, Zincum Gluconicum, Funiculus Umbilicalis Suis, Lymph Node (Suis), Oophorinum (Suis), Uterus (Suis), Glandula Suprarenalis Suis, Thyroidinum Suis, Boricum Acidum, Kreosotum, Mercurius Solubilis, Pulsatilla (Pratensis), Sepia, Calcarea Carbonica, Phosphorus, Sabina, Candida Albicans, Herpes Simplex 1 And 2 Nosode, Human Papilloma Nosode

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of menstrual pain and vaginal irritation.

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

Keep out of reach of children. 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 menstrual pain and vaginal irritation.

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
GYNETOX
HOMEOPATHIC
1 FL OZ (30 ml)

GynetoxGynetox

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
43857-0565-12024-10-17C16284748780-1f386c649-cee1-0266-e053-dadaa90a7c1aDRUG FACTS:
43857-0565-12023-01-30C16284748780-1f386c649-cee1-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0565-1Gynetox30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0565GYNETOX (ANGELICA ARCHANGELICA, CIMICIFUGA RACEMOSA, ZINCUM GLUCONICUM, FUNICULUS UMBILICALIS SUIS, LYMPH NODE (SUIS), OOPHORINUM (SUIS), UTERUS (SUIS), GLANDULA SUPRARENALIS SUIS, THYROIDINUM SUIS, BORICUM ACIDUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, CALCAREA CARBONICA, PHOSPHORUS, SABINA, CANDIDA ALBICANS, HERPES SIMPLEX 1 AND 2 NOSODE, HUMAN PAPILLOMA NOSODE) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2Current NDC, Legacy NDC, 1 package rows20241019_80a5b1f7-9b6b-4314-91c6-20e6b61a5686.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-056543857-0565-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANGELICA ARCHANGELICA ROOTDTN01M69SNACTIB
BLACK COHOSHK73E24S6X9ACTIB
ZINC GLUCONATEU6WSN5SQ1ZACTIB
SUS SCROFA UMBILICAL CORD118OYG6W3HACTIB
SUS SCROFA LYMPH33A7VYU29LACTIB
SUS SCROFA OVARYS7YTV04R8OACTIB
SUS SCROFA UTERUS2595C75F1PACTIB
SUS SCROFA ADRENAL GLAND398IYQ16YVACTIB
THYROID6RV024OAUQACTIB
BORIC ACIDR57ZHV85D4ACTIB
WOOD CREOSOTE3JYG22FD73ACTIB
MERCURIUS SOLUBILIS324Y4038G2ACTIB
PULSATILLA VULGARIS WHOLEI76KB35JEVACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
PHOSPHORUS27YLU75U4WACTIB
JUNIPERUS SABINA LEAFY TWIGZ5BEX9K2G1ACTIB
CANDIDA ALBICANS4D7G21HDBCACTIB
HUMAN HERPESVIRUS 122G38P19RLACTIB
HUMAN HERPESVIRUS 274J6DNH49UACTIB
HUMAN PAPILLOMAVIRUS23CVL7WF4JACTIB
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
GynetoxANGELICA ARCHANGELICA, CIMICIFUGA RACEMOSA, ZINCUM GLUCONICUM, FUNICULUS UMBILICALIS SUIS, LYMPH NODE (SUIS), OOPHORINUM (SUIS), UTERUS (SUIS), GLANDULA SUPRARENALIS SUIS, THYROIDINUM SUIS, BORICUM ACIDUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, CALCAREA CARBONICA, PHOSPHORUS, SABINA, CANDIDA ALBICANS, HERPES SIMPLEX 1 AND 2 NOSODE, HUMAN PAPILLOMA NOSODEBioActive Nutritional, Inc.80a5b1f7-9b6b-4314-91c6-20e6b61a56862024-10-17WarningsExact identifier
ndc (package): 43857-0565-1
ndc (product): 43857-0565
ndc11 (package): 43857056501
spl id: c7448b21-f07a-4e31-ad0f-1db7550a9004
spl set id: 80a5b1f7-9b6b-4314-91c6-20e6b61a5686

Reported adverse events (FAERS/openFDA)#

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