Gynestat

Product NDC
44911-0279
Requested package NDC
44911-0279-1
11-digit product format
449110279
Labeler code
44911
Product ID
44911-0279_2df8896c-9511-4570-968f-ea020dd3de00
Type
HUMAN OTC DRUG
Nonproprietary name
Cimicifuga Racemosa, Eucalyptus Globulus, Argentum Nitricum, Calcarea Carbonica, Kali Bichromicum, Kreosotum, Mercurius Solubilis, Pulsatilla (Pratensis), Sepia, Staphysagria, Thuja Occidentalis
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-10-23
Marketing end
2028-04-06
Substance
BLACK COHOSH; DELPHINIUM STAPHISAGRIA SEED; EUCALYPTUS GLOBULUS LEAF; MERCURIUS SOLUBILIS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM DICHROMATE; PULSATILLA PRATENSIS; SEPIA OFFICINALIS JUICE; SILVER NITRATE; THUJA OCCIDENTALIS LEAFY TWIG; WOOD CREOSOTE
Active strength
3; 12; 3; 12; 12; 12; 12; 12; 12; 12; 12 [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
NDC exclude flag
No
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 · 4 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Additional Listing Data#

Finished product
Yes
Brand name base
Gynestat

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BLACK COHOSH3 [hp_X]/mL
EUCALYPTUS GLOBULUS LEAF12 [hp_X]/mL
SILVER NITRATE3 [hp_X]/mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]/mL
POTASSIUM DICHROMATE12 [hp_X]/mL
WOOD CREOSOTE12 [hp_X]/mL
MERCURIUS SOLUBILIS12 [hp_X]/mL
PULSATILLA PRATENSIS12 [hp_X]/mL
SEPIA OFFICINALIS JUICE12 [hp_X]/mL
DELPHINIUM STAPHISAGRIA SEED12 [hp_X]/mL
THUJA OCCIDENTALIS LEAFY TWIG12 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 11 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K73E24S6X9Internal UNII lookup
S546YLW6E6Internal UNII lookup
95IT3W8JZEInternal UNII lookup
2E32821G6IInternal UNII lookup
T4423S18FMInternal UNII lookup
3JYG22FD73Internal UNII lookup
324Y4038G2Internal UNII lookup
8E272251DIInternal UNII lookup
QDL83WN8C2Internal UNII lookup
00543AP1JVInternal UNII lookup
1NT28V9397Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fb712113-47b5-4e23-aab0-e3242f8655e5Available on FDA.report

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#

Effective, Related label table
EffectiveRelated label
2024-08-02Drug Facts:
2023-01-30Drug Facts:
2021-05-25Drug Facts:
2021-01-29Drug Facts:

DailyMed Package Descriptions#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BLACK COHOSHACTIVE INGREDIENTK73E24S6X9GYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]1
DELPHINIUM STAPHISAGRIA SEEDACTIVE INGREDIENT00543AP1JVGYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]1
EUCALYPTUS GLOBULUS LEAFACTIVE INGREDIENTS546YLW6E6GYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]1
MERCURIUS SOLUBILISACTIVE INGREDIENT324Y4038G2GYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]1
OYSTER SHELL CALCIUM CARBONATE, CRUDEACTIVE INGREDIENT2E32821G6IGYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]1
POTASSIUM DICHROMATEACTIVE INGREDIENTT4423S18FMGYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]1
PULSATILLA PRATENSISACTIVE INGREDIENT8E272251DIGYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]1
SEPIA OFFICINALIS JUICEACTIVE INGREDIENTQDL83WN8C2GYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]1
SILVER NITRATEACTIVE INGREDIENT95IT3W8JZEGYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]1
THUJA OCCIDENTALIS LEAFY TWIGACTIVE INGREDIENT1NT28V9397GYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]1
WOOD CREOSOTEACTIVE INGREDIENT3JYG22FD73GYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]1
BLACK COHOSHACTIVE MOIETYK73E24S6X9GYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]1
DELPHINIUM STAPHISAGRIA SEEDACTIVE MOIETY00543AP1JVGYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]1
DICHROMATE IONACTIVE MOIETY9LKY4BFN2VGYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]1
EUCALYPTUS GLOBULUS LEAFACTIVE MOIETYS546YLW6E6GYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]1
MERCURIUS SOLUBILISACTIVE MOIETY324Y4038G2GYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]1
OYSTER SHELL CALCIUM CARBONATE, CRUDEACTIVE MOIETY2E32821G6IGYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]1
PULSATILLA PRATENSISACTIVE MOIETY8E272251DIGYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]1
SEPIA OFFICINALIS JUICEACTIVE MOIETYQDL83WN8C2GYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]1
SILVER CATIONACTIVE MOIETY57N7B0K90AGYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]1
THUJA OCCIDENTALIS LEAFY TWIGACTIVE MOIETY1NT28V9397GYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]1
WOOD CREOSOTEACTIVE MOIETY3JYG22FD73GYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MGYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RGYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]1

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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0279-14491102790130 mL in 1 BOTTLE, DROPPER (44911-0279-1) 30 ml2015-10-232028-04-06NoNoCurrent