Home NDC 43857-0033 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 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, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 43857-0033-1 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 43857-0033-1 9bebd1f3094a…5416666fcb17…
Additional Listing Data#
Finished product Yes
Brand name base Gynobalance
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PRASTERONE 8 [hp_X]/mL ESTRADIOL 6 [hp_X]/mL PREGNENOLONE 8 [hp_X]/mL PROGESTERONE 8 [hp_X]/mL TESTOSTERONE 8 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 5 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 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
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 Gynobalance DEHYDROEPIANDROSTERONE, ESTRADIOL, PREGNENOLONE, PROGESTERONE, TESTOSTERONE BioActive Nutritional, Inc. 61fa6e6e-42f5-4992-87b5-0770218abc8c 2023-08-10 Warnings Exact identifier ndc (product): 43857-0033
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