Home NDC 44911-0716 Gynestat
Product NDC 44911-0716
11-digit product format 449110716
Labeler code 44911
Product ID 44911-0716_f4878551-dc72-456e-b285-028b5bfdafcb
Type HUMAN OTC DRUG
Nonproprietary name Cimicifuga Racemosa, Eucalyptus Globulus, Argentum Nitricum, Aurum Muriaticum Natronatum, Borax, Calcarea Carbonica, Kali Bichromicum, Kreosotum, Lilium Tigrinum, Mercurius Solubilis, Pulsatilla (Pratensis), Sepia, Staphysagria, Thuja Occidentalis
Dosage form LIQUID
Route ORAL
Labeler Energique, Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2024-08-02
Substance BLACK COHOSH; DELPHINIUM STAPHISAGRIA SEED; EUCALYPTUS GLOBULUS LEAF; LILIUM LANCIFOLIUM WHOLE FLOWERING; MERCURIUS SOLUBILIS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM DICHROMATE; PULSATILLA PRATENSIS WHOLE; SEPIA OFFICINALIS JUICE; SILVER NITRATE; SODIUM BORATE; SODIUM TETRACHLOROAURATE; THUJA OCCIDENTALIS LEAFY TWIG; WOOD CREOSOTE
Active strength 3; 12; 3; 12; 12; 12; 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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Gynestat
Listing expiration 2026-12-31 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 SODIUM TETRACHLOROAURATE 12 [hp_X]/mL SODIUM BORATE 12 [hp_X]/mL OYSTER SHELL CALCIUM CARBONATE, CRUDE 12 [hp_X]/mL POTASSIUM DICHROMATE 12 [hp_X]/mL WOOD CREOSOTE 12 [hp_X]/mL LILIUM LANCIFOLIUM WHOLE FLOWERING 12 [hp_X]/mL MERCURIUS SOLUBILIS 12 [hp_X]/mL PULSATILLA PRATENSIS WHOLE 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 · 14 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 44911-0716-1 Gynestat 30 mL in 1 BOTTLE, DROPPER LIQUID 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44911-0716 GYNESTAT (CIMICIFUGA RACEMOSA, EUCALYPTUS GLOBULUS, ARGENTUM NITRICUM, AURUM MURIATICUM NATRONATUM, BORAX, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, LILIUM TIGRINUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.] 1 Current NDC, 1 package rows 20240805_3af1d2f1-b3f3-4135-9148-726d08bbd5d4.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, AURUM MURIATICUM NATRONATUM, BORAX, CALCAREA CARBONICA, KALI BICHROMICUM, KREOSOTUM, LILIUM TIGRINUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS Energique, Inc. 3af1d2f1-b3f3-4135-9148-726d08bbd5d4 2024-08-02 Warnings Exact identifier ndc (product): 44911-0716
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 44911-0716-1 44911071601 30 mL in 1 BOTTLE, DROPPER (44911-0716-1) 30 ml 2024-08-02 No No Current