FDA.reportPublic FDA data

Gynestat

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2024-08-02
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:27:43

Label at a glance#

ProductGynestat
Active ingredientBLACK COHOSH, EUCALYPTUS GLOBULUS LEAF, SILVER NITRATE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, POTASSIUM DICHROMATE, WOOD CREOSOTE, MERCURIUS SOLUBILIS, PULSATILLA PRATENSIS, SEPIA OFFICINALIS JUICE, DELPHINIUM STAPHISAGRIA SEED, THUJA OCCIDENTALIS LEAFY TWIG
Label structure9 sections

Dosage and administration

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(in each drop): 11.09% of Argentum Nitricum 12X, Calcarea Carbonica 12X, Kali Bichromicum 12X, Kreosotum 12X, Mercurius Solubilis 12X, Pulsatilla (Pratensis) 12X, Sepia 12X, Staphysagria 12X, Thuja Occidentalis 12X; 0.10% of Cimicifuga Racemosa 3X, Eucalyptus Globulus 3X.

INDICATIONS:

OTC - PURPOSE SECTION

May temporarily relieve menstrual pain and vaginal irritation.**

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

WARNINGS:

WARNINGS SECTION

If pregnant or breast-feeding, ask a health 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

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

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve menstrual pain and vaginal irritation.**

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

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized water, 20% Ethanol.

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579 800-869-8078

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

GYNESTAT

1 fL. oz. (30 ml)

GynestatGynestat

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0279-12024-08-02C16284748780-1ba0f9c33-4800-a910-e053-dadaa90a0b85Drug Facts:
44911-0279-12023-01-30C16284748780-1ba0f9c33-4800-a910-e053-dadaa90a0b85Drug Facts:
44911-0279-12021-05-25C16284748780-1ba0f9c33-4800-a910-e053-dadaa90a0b85Drug Facts:
44911-0279-12021-01-29C16284748780-1ba0f9c33-4800-a910-e053-dadaa90a0b85Drug Facts:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0279-1Gynestat30 mL in 1 BOTTLE, DROPPERLIQUID304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0279GYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]4Current NDC, Legacy NDC, 1 package rows20240805_fb712113-47b5-4e23-aab0-e3242f8655e5.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BLACK COHOSHACTIVE INGREDIENTK73E24S6X91
DELPHINIUM STAPHISAGRIA SEEDACTIVE INGREDIENT00543AP1JV1
EUCALYPTUS GLOBULUS LEAFACTIVE INGREDIENTS546YLW6E61
MERCURIUS SOLUBILISACTIVE INGREDIENT324Y4038G21
OYSTER SHELL CALCIUM CARBONATE, CRUDEACTIVE INGREDIENT2E32821G6I1
POTASSIUM DICHROMATEACTIVE INGREDIENTT4423S18FM1
PULSATILLA PRATENSISACTIVE INGREDIENT8E272251DI1
SEPIA OFFICINALIS JUICEACTIVE INGREDIENTQDL83WN8C21
SILVER NITRATEACTIVE INGREDIENT95IT3W8JZE1
THUJA OCCIDENTALIS LEAFY TWIGACTIVE INGREDIENT1NT28V93971
WOOD CREOSOTEACTIVE INGREDIENT3JYG22FD731
BLACK COHOSHACTIVE MOIETYK73E24S6X91
DELPHINIUM STAPHISAGRIA SEEDACTIVE MOIETY00543AP1JV1
DICHROMATE IONACTIVE MOIETY9LKY4BFN2V1
EUCALYPTUS GLOBULUS LEAFACTIVE MOIETYS546YLW6E61
MERCURIUS SOLUBILISACTIVE MOIETY324Y4038G21
OYSTER SHELL CALCIUM CARBONATE, CRUDEACTIVE MOIETY2E32821G6I1
PULSATILLA PRATENSISACTIVE MOIETY8E272251DI1
SEPIA OFFICINALIS JUICEACTIVE MOIETYQDL83WN8C21
SILVER CATIONACTIVE MOIETY57N7B0K90A1
THUJA OCCIDENTALIS LEAFY TWIGACTIVE MOIETY1NT28V93971
WOOD CREOSOTEACTIVE MOIETY3JYG22FD731
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-027944911-0279-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
BLACK COHOSHK73E24S6X9ACTIB
EUCALYPTUS GLOBULUS LEAFS546YLW6E6ACTIB
SILVER NITRATE95IT3W8JZEACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
POTASSIUM DICHROMATET4423S18FMACTIB
WOOD CREOSOTE3JYG22FD73ACTIB
MERCURIUS SOLUBILIS324Y4038G2ACTIB
PULSATILLA PRATENSIS8E272251DIACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
DELPHINIUM STAPHISAGRIA SEED00543AP1JVACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

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
GynestatCIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALISEnergique, Inc.fb712113-47b5-4e23-aab0-e3242f8655e52024-08-02WarningsExact identifier
ndc (package): 44911-0279-1
ndc (product): 44911-0279
ndc11 (package): 44911027901
spl id: 2df8896c-9511-4570-968f-ea020dd3de00
spl set id: fb712113-47b5-4e23-aab0-e3242f8655e5

Reported adverse events (FAERS/openFDA)#

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