Home NDC 44911-0279-1 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 date Snapshot Source SHA-256 2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Additional Listing Data#
Finished product Yes
Brand name base Gynestat
Active Ingredients# Ingredient, Strength table Ingredient Strength BLACK COHOSH 3 [hp_X]/mL EUCALYPTUS GLOBULUS LEAF 12 [hp_X]/mL SILVER NITRATE 3 [hp_X]/mL OYSTER SHELL CALCIUM CARBONATE, CRUDE 12 [hp_X]/mL POTASSIUM DICHROMATE 12 [hp_X]/mL WOOD CREOSOTE 12 [hp_X]/mL MERCURIUS SOLUBILIS 12 [hp_X]/mL PULSATILLA PRATENSIS 12 [hp_X]/mL SEPIA OFFICINALIS JUICE 12 [hp_X]/mL DELPHINIUM STAPHISAGRIA SEED 12 [hp_X]/mL THUJA OCCIDENTALIS LEAFY TWIG 12 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 11 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 44911-0279-1 Gynestat 30 mL in 1 BOTTLE, DROPPER LIQUID 30 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BLACK COHOSH ACTIVE INGREDIENT K73E24S6X9 GYNESTAT (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 SEED ACTIVE INGREDIENT 00543AP1JV GYNESTAT (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 LEAF ACTIVE INGREDIENT S546YLW6E6 GYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.] 1 MERCURIUS SOLUBILIS ACTIVE INGREDIENT 324Y4038G2 GYNESTAT (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, CRUDE ACTIVE INGREDIENT 2E32821G6I GYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.] 1 POTASSIUM DICHROMATE ACTIVE INGREDIENT T4423S18FM GYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.] 1 PULSATILLA PRATENSIS ACTIVE INGREDIENT 8E272251DI GYNESTAT (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 JUICE ACTIVE INGREDIENT QDL83WN8C2 GYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.] 1 SILVER NITRATE ACTIVE INGREDIENT 95IT3W8JZE GYNESTAT (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 TWIG ACTIVE INGREDIENT 1NT28V9397 GYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.] 1 WOOD CREOSOTE ACTIVE INGREDIENT 3JYG22FD73 GYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.] 1 BLACK COHOSH ACTIVE MOIETY K73E24S6X9 GYNESTAT (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 SEED ACTIVE MOIETY 00543AP1JV GYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.] 1 DICHROMATE ION ACTIVE MOIETY 9LKY4BFN2V GYNESTAT (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 LEAF ACTIVE MOIETY S546YLW6E6 GYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.] 1 MERCURIUS SOLUBILIS ACTIVE MOIETY 324Y4038G2 GYNESTAT (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, CRUDE ACTIVE MOIETY 2E32821G6I GYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.] 1 PULSATILLA PRATENSIS ACTIVE MOIETY 8E272251DI GYNESTAT (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 JUICE ACTIVE MOIETY QDL83WN8C2 GYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.] 1 SILVER CATION ACTIVE MOIETY 57N7B0K90A GYNESTAT (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 TWIG ACTIVE MOIETY 1NT28V9397 GYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.] 1 WOOD CREOSOTE ACTIVE MOIETY 3JYG22FD73 GYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M GYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R GYNESTAT (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 NDC Dashboard title SPL version Validation Dashboard ZIP 44911-0279 GYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.] 4 Current NDC, Legacy NDC, 1 package rows 20240805_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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Gynestat CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS Energique, Inc. fb712113-47b5-4e23-aab0-e3242f8655e5 2024-08-02 Warnings Exact identifier ndc (package): 44911-0279-1 ndc (product): 44911-0279 ndc11 (package): 44911027901
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 44911-0279-1 44911027901 30 mL in 1 BOTTLE, DROPPER (44911-0279-1) 30 ml 2015-10-23 2028-04-06 No No Current