Gynobalance
- Product NDC
- 43857-0033
- 11-digit product format
- 438570033
- Labeler code
- 43857
- Product ID
- 43857-0033_24deb803-ab80-49ec-81e5-4ef5ce24fcf5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dehydroepiandrosterone, Estradiol, Pregnenolone, Progesterone, Testosterone
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- BioActive Nutritional, Inc.
- Marketing category
- UNAPPROVED HOMEOPATHIC
- Marketing start
- 2013-01-18
- Substance
- ESTRADIOL; PRASTERONE; PREGNENOLONE; PROGESTERONE; TESTOSTERONE
- Active strength
- 8; 6; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
- Pharmacologic classes
- Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS], Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone [CS], Progesterone [EPC]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Gynobalance
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESTRADIOL | 8 [hp_X]/mL |
| PRASTERONE | 6 [hp_X]/mL |
| PREGNENOLONE | 8 [hp_X]/mL |
| PROGESTERONE | 8 [hp_X]/mL |
| TESTOSTERONE | 8 [hp_X]/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4TI98Z838E, 459AG36T1B, 73R90F7MQ8, 4G7DS2Q64Y, 3XMK78S47O |
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 |
|---|
| 43857-0033-1 | Gynobalance | 30 mL in 1 BOTTLE, DROPPER | LIQUID | 30 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ESTRADIOL | ACTIVE INGREDIENT | 4TI98Z838E | GYNOBALANCE (DEHYDROEPIANDROSTERONE, ESTRADIOL, PREGNENOLONE, PROGESTERONE, TESTOSTERONE) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 2 | |
| PRASTERONE | ACTIVE INGREDIENT | 459AG36T1B | GYNOBALANCE (DEHYDROEPIANDROSTERONE, ESTRADIOL, PREGNENOLONE, PROGESTERONE, TESTOSTERONE) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 2 | |
| PREGNENOLONE | ACTIVE INGREDIENT | 73R90F7MQ8 | GYNOBALANCE (DEHYDROEPIANDROSTERONE, ESTRADIOL, PREGNENOLONE, PROGESTERONE, TESTOSTERONE) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 2 | |
| PROGESTERONE | ACTIVE INGREDIENT | 4G7DS2Q64Y | GYNOBALANCE (DEHYDROEPIANDROSTERONE, ESTRADIOL, PREGNENOLONE, PROGESTERONE, TESTOSTERONE) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 2 | |
| TESTOSTERONE | ACTIVE INGREDIENT | 3XMK78S47O | GYNOBALANCE (DEHYDROEPIANDROSTERONE, ESTRADIOL, PREGNENOLONE, PROGESTERONE, TESTOSTERONE) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 2 | |
| ESTRADIOL | ACTIVE MOIETY | 4TI98Z838E | GYNOBALANCE (DEHYDROEPIANDROSTERONE, ESTRADIOL, PREGNENOLONE, PROGESTERONE, TESTOSTERONE) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 2 | |
| PRASTERONE | ACTIVE MOIETY | 459AG36T1B | GYNOBALANCE (DEHYDROEPIANDROSTERONE, ESTRADIOL, PREGNENOLONE, PROGESTERONE, TESTOSTERONE) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 2 | |
| PREGNENOLONE | ACTIVE MOIETY | 73R90F7MQ8 | GYNOBALANCE (DEHYDROEPIANDROSTERONE, ESTRADIOL, PREGNENOLONE, PROGESTERONE, TESTOSTERONE) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 2 | |
| PROGESTERONE | ACTIVE MOIETY | 4G7DS2Q64Y | GYNOBALANCE (DEHYDROEPIANDROSTERONE, ESTRADIOL, PREGNENOLONE, PROGESTERONE, TESTOSTERONE) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 2 | |
| TESTOSTERONE | ACTIVE MOIETY | 3XMK78S47O | GYNOBALANCE (DEHYDROEPIANDROSTERONE, ESTRADIOL, PREGNENOLONE, PROGESTERONE, TESTOSTERONE) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 2 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | GYNOBALANCE (DEHYDROEPIANDROSTERONE, ESTRADIOL, PREGNENOLONE, PROGESTERONE, TESTOSTERONE) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | GYNOBALANCE (DEHYDROEPIANDROSTERONE, ESTRADIOL, PREGNENOLONE, PROGESTERONE, TESTOSTERONE) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 2 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | GYNOBALANCE (DEHYDROEPIANDROSTERONE, ESTRADIOL, PREGNENOLONE, PROGESTERONE, TESTOSTERONE) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | GYNOBALANCE (DEHYDROEPIANDROSTERONE, ESTRADIOL, PREGNENOLONE, PROGESTERONE, TESTOSTERONE) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43857-0033 | GYNOBALANCE (DEHYDROEPIANDROSTERONE, ESTRADIOL, PREGNENOLONE, PROGESTERONE, TESTOSTERONE) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20230811_61fa6e6e-42f5-4992-87b5-0770218abc8c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43857-0033-1 | 43857003301 | 30 mL in 1 BOTTLE, DROPPER (43857-0033-1) | 30 ml | 2016-08-16 | 0000-00-00 | No | No | Current |