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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43857-0565-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43857-0565-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage43857-0565-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage43857-0565-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage43857-0565-11332a3947898…d4bfe170f9cd…

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
ZINC GLUCONATE6 [hp_X]/mL
SUS SCROFA UMBILICAL CORD8 [hp_X]/mL
SUS SCROFA LYMPH8 [hp_X]/mL
SUS SCROFA OVARY8 [hp_X]/mL
SUS SCROFA UTERUS8 [hp_X]/mL
SUS SCROFA ADRENAL GLAND9 [hp_X]/mL
THYROID9 [hp_X]/mL
BORIC ACID12 [hp_X]/mL
WOOD CREOSOTE12 [hp_X]/mL
MERCURIUS SOLUBILIS12 [hp_X]/mL
PULSATILLA VULGARIS WHOLE12 [hp_X]/mL
SEPIA OFFICINALIS JUICE12 [hp_X]/mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE30 [hp_X]/mL
PHOSPHORUS30 [hp_X]/mL
JUNIPERUS SABINA LEAFY TWIG30 [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

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 21 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
DTN01M69SNInternal UNII lookup
K73E24S6X9Internal UNII lookup
U6WSN5SQ1ZInternal UNII lookup
118OYG6W3HInternal UNII lookup
33A7VYU29LInternal UNII lookup
S7YTV04R8OInternal UNII lookup
2595C75F1PInternal UNII lookup
398IYQ16YVInternal UNII lookup
6RV024OAUQInternal UNII lookup
R57ZHV85D4Internal UNII lookup
3JYG22FD73Internal UNII lookup
324Y4038G2Internal UNII lookup
I76KB35JEVInternal UNII lookup
QDL83WN8C2Internal UNII lookup
2E32821G6IInternal UNII lookup
27YLU75U4WInternal UNII lookup
Z5BEX9K2G1Internal UNII lookup
4D7G21HDBCInternal UNII lookup
22G38P19RLInternal UNII lookup
74J6DNH49UInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
80a5b1f7-9b6b-4314-91c6-20e6b61a5686Available on FDA.report

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

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 (product): 43857-0565

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