Gynestat
- Product NDC
- 44911-0279
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Gynestat
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BLACK COHOSH | 3 [hp_X]/mL |
| DELPHINIUM STAPHISAGRIA SEED | 12 [hp_X]/mL |
| EUCALYPTUS GLOBULUS LEAF | 3 [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 | 12 [hp_X]/mL |
| SEPIA OFFICINALIS JUICE | 12 [hp_X]/mL |
| SILVER NITRATE | 12 [hp_X]/mL |
| THUJA OCCIDENTALIS LEAFY TWIG | 12 [hp_X]/mL |
| WOOD CREOSOTE | 12 [hp_X]/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | K73E24S6X9, 00543AP1JV, S546YLW6E6, 324Y4038G2, 2E32821G6I, T4423S18FM, 8E272251DI, QDL83WN8C2, 95IT3W8JZE, 1NT28V9397, 3JYG22FD73 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6cca4355-1206-91f7-02de-17eef38a8622 | Product name | 1 | 20140508 |
| 751c581a-bf64-2fd7-b3ec-ca02c83e4a00 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 44911-0279-1 | 2024-08-02 | C162847 | 48780-1 | ba0f9c33-4800-a910-e053-dadaa90a0b85 | Drug Facts: |
| 44911-0279-1 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-4800-a910-e053-dadaa90a0b85 | Drug Facts: |
| 44911-0279-1 | 2021-05-25 | C162847 | 48780-1 | ba0f9c33-4800-a910-e053-dadaa90a0b85 | Drug Facts: |
| 44911-0279-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-4800-a910-e053-dadaa90a0b85 | Drug Facts: |
DailyMed Package Descriptions#
| 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#
DailyMed Dashboard NDC Coverage#
| 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 |
Packages#
| 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 |