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 |
| DELPHINIUM STAPHISAGRIA SEED | 12 [hp_X]/mL |
| EUCALYPTUS GLOBULUS LEAF | 3 [hp_X]/mL |
| LILIUM LANCIFOLIUM WHOLE FLOWERING | 12 [hp_X]/mL |
| MERCURIUS SOLUBILIS | 12 [hp_X]/mL |
| OYSTER SHELL CALCIUM CARBONATE, CRUDE | 12 [hp_X]/mL |
| POTASSIUM DICHROMATE | 12 [hp_X]/mL |
| PULSATILLA PRATENSIS WHOLE | 12 [hp_X]/mL |
| SEPIA OFFICINALIS JUICE | 12 [hp_X]/mL |
| SILVER NITRATE | 12 [hp_X]/mL |
| SODIUM BORATE | 12 [hp_X]/mL |
| SODIUM TETRACHLOROAURATE | 12 [hp_X]/mL |
| THUJA OCCIDENTALIS LEAFY TWIG | 12 [hp_X]/mL |
| WOOD CREOSOTE | 12 [hp_X]/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | K73E24S6X9, 00543AP1JV, S546YLW6E6, X67Z2963PI, 324Y4038G2, 2E32821G6I, T4423S18FM, 8E272251DI, QDL83WN8C2, 95IT3W8JZE, 91MBZ8H3QO, 7FT6QUT299, 1NT28V9397, 3JYG22FD73 |
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 |
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 |