Gynetox

Product NDC
43857-0565
11-digit product format
438570565
Labeler code
43857
Product ID
43857-0565_c7448b21-f07a-4e31-ad0f-1db7550a9004
Type
HUMAN OTC DRUG
Nonproprietary name
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
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-02-18
Substance
ANGELICA ARCHANGELICA ROOT; BLACK COHOSH; BORIC ACID; CANDIDA ALBICANS; HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2; HUMAN PAPILLOMAVIRUS; JUNIPERUS SABINA LEAFY TWIG; MERCURIUS SOLUBILIS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PULSATILLA VULGARIS WHOLE; SEPIA OFFICINALIS JUICE; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH; SUS SCROFA OVARY; SUS SCROFA UMBILICAL CORD; SUS SCROFA UTERUS; THYROID; WOOD CREOSOTE; ZINC GLUCONATE
Active strength
3; 3; 12; 30; 30; 30; 30; 30; 12; 30; 30; 12; 12; 9; 8; 8; 8; 8; 9; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gynetox
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANGELICA ARCHANGELICA ROOT3 [hp_X]/mL
BLACK COHOSH3 [hp_X]/mL
BORIC ACID12 [hp_X]/mL
CANDIDA ALBICANS30 [hp_X]/mL
HUMAN HERPESVIRUS 130 [hp_X]/mL
HUMAN HERPESVIRUS 230 [hp_X]/mL
HUMAN PAPILLOMAVIRUS30 [hp_X]/mL
JUNIPERUS SABINA LEAFY TWIG30 [hp_X]/mL
MERCURIUS SOLUBILIS12 [hp_X]/mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE30 [hp_X]/mL
PHOSPHORUS30 [hp_X]/mL
PULSATILLA VULGARIS WHOLE12 [hp_X]/mL
SEPIA OFFICINALIS JUICE12 [hp_X]/mL
SUS SCROFA ADRENAL GLAND9 [hp_X]/mL
SUS SCROFA LYMPH8 [hp_X]/mL
SUS SCROFA OVARY8 [hp_X]/mL
SUS SCROFA UMBILICAL CORD8 [hp_X]/mL
SUS SCROFA UTERUS8 [hp_X]/mL
THYROID9 [hp_X]/mL
WOOD CREOSOTE12 [hp_X]/mL
ZINC GLUCONATE6 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiDTN01M69SN, K73E24S6X9, R57ZHV85D4, 4D7G21HDBC, 22G38P19RL, 74J6DNH49U, 23CVL7WF4J, Z5BEX9K2G1, 324Y4038G2, 2E32821G6I, 27YLU75U4W, I76KB35JEV, QDL83WN8C2, 398IYQ16YV, 33A7VYU29L, S7YTV04R8O, 118OYG6W3H, 2595C75F1P, 6RV024OAUQ, 3JYG22FD73

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0565-14385705650130 mL in 1 BOTTLE, DROPPER (43857-0565-1) 30 ml2021-02-180000-00-00NoNoCurrent