Androbalance

Product NDC
43857-0284
11-digit product format
438570284
Labeler code
43857
Product ID
43857-0284_0900ddef-63ec-4d5f-aa9d-10e023191a02
Type
HUMAN OTC DRUG
Nonproprietary name
DHEA (Dehydroepiandrosterone) Pregnenolone, Progesterone, Testosterone
Dosage form
SPRAY
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2014-02-24
Substance
PRASTERONE; PREGNENOLONE; PROGESTERONE; TESTOSTERONE
Active strength
6; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS], 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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage43857-0284-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage43857-0284-19bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Androbalance
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRASTERONE6 [hp_X]/mL
PREGNENOLONE8 [hp_X]/mL
PROGESTERONE8 [hp_X]/mL
TESTOSTERONE8 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
459AG36T1BInternal UNII lookup
73R90F7MQ8Internal UNII lookup
4G7DS2Q64YInternal UNII lookup
3XMK78S47OInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e231695a-165a-419e-b594-34f9522503acAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2db4fc38-a116-b0ab-3dae-57df54e5f212Product name220250121
386d1b2a-e9b7-0c83-111f-2a77b92895b3Product name520240422
7d55b53c-798b-47ae-992b-3921493a8303Product name120230322
8d753fd6-75b2-4f12-bcbf-339392960afaProduct name120230303
4fbda828-a5be-46fe-83ec-a88da4359919Product name120230104
b46148e2-ee15-98d5-12f0-f5ec8745f6fcProduct name320220927
76820076-f087-4073-b1d1-aa04b361335eProduct name220220921
93cc9bee-8bdc-273d-ec7f-c2c52535317aProduct name720210902
a6389cd1-36d1-4b5c-9934-1139bee93605Product name520210601
d3229c1a-4e51-4e04-9b13-00d24fd35242Product name120200821
f4f0889f-ee8b-471f-9a37-02a035280637Product name120200122
213f0591-95c1-b398-40b7-08b31f66b026Product name420190206
09e1afd3-f431-4380-82c5-438884c25615Product name120190111
a6389cd1-36d1-4b5c-9934-1139bee93605Product name320171212
502efed8-01a5-ef6a-61c6-fe8302b6e26bProduct name220171113
8b700cfd-17dd-41a2-90f5-a80ae8a989a2Product name120171113
9ce0e503-4ae7-2c6a-39ae-85285c29db68Product name220171113
86ca2ee7-106a-420e-9137-a9ec1af5dbc1Product name120170110
96bdf4b3-71cd-433d-9723-89e50f852992Product name120150810
85b2d644-53b2-f2dc-4dbc-859116ce56c0Product name120140508
d048f0e3-3c40-8816-8c5c-0ca5cd189aacProduct name120140508
ed2e617f-f28a-1df1-f9fc-c79702f31271Product name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-06-05DRUG FACTS:
2023-01-30DRUG FACTS:
2021-07-28DRUG FACTS:
2020-01-31DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0284-1Androbalance30 mL in 1 BOTTLE, SPRAYSPRAY305

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRASTERONEACTIVE INGREDIENT459AG36T1BANDROBALANCE (DHEA (DEHYDROEPIANDROSTERONE) PREGNENOLONE, PROGESTERTONE, TESTOSTERONE) SPRAY [BIOACTIVE NUTRITIONAL, INC.]1
PREGNENOLONEACTIVE INGREDIENT73R90F7MQ8ANDROBALANCE (DHEA (DEHYDROEPIANDROSTERONE) PREGNENOLONE, PROGESTERTONE, TESTOSTERONE) SPRAY [BIOACTIVE NUTRITIONAL, INC.]1
PROGESTERONEACTIVE INGREDIENT4G7DS2Q64YANDROBALANCE (DHEA (DEHYDROEPIANDROSTERONE) PREGNENOLONE, PROGESTERTONE, TESTOSTERONE) SPRAY [BIOACTIVE NUTRITIONAL, INC.]1
TESTOSTERONEACTIVE INGREDIENT3XMK78S47OANDROBALANCE (DHEA (DEHYDROEPIANDROSTERONE) PREGNENOLONE, PROGESTERTONE, TESTOSTERONE) SPRAY [BIOACTIVE NUTRITIONAL, INC.]1
PRASTERONEACTIVE MOIETY459AG36T1BANDROBALANCE (DHEA (DEHYDROEPIANDROSTERONE) PREGNENOLONE, PROGESTERTONE, TESTOSTERONE) SPRAY [BIOACTIVE NUTRITIONAL, INC.]1
PREGNENOLONEACTIVE MOIETY73R90F7MQ8ANDROBALANCE (DHEA (DEHYDROEPIANDROSTERONE) PREGNENOLONE, PROGESTERTONE, TESTOSTERONE) SPRAY [BIOACTIVE NUTRITIONAL, INC.]1
PROGESTERONEACTIVE MOIETY4G7DS2Q64YANDROBALANCE (DHEA (DEHYDROEPIANDROSTERONE) PREGNENOLONE, PROGESTERTONE, TESTOSTERONE) SPRAY [BIOACTIVE NUTRITIONAL, INC.]1
TESTOSTERONEACTIVE MOIETY3XMK78S47OANDROBALANCE (DHEA (DEHYDROEPIANDROSTERONE) PREGNENOLONE, PROGESTERTONE, TESTOSTERONE) SPRAY [BIOACTIVE NUTRITIONAL, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPANDROBALANCE (DHEA (DEHYDROEPIANDROSTERONE) PREGNENOLONE, PROGESTERTONE, TESTOSTERONE) SPRAY [BIOACTIVE NUTRITIONAL, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXANDROBALANCE (DHEA (DEHYDROEPIANDROSTERONE) PREGNENOLONE, PROGESTERTONE, TESTOSTERONE) SPRAY [BIOACTIVE NUTRITIONAL, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUANDROBALANCE (DHEA (DEHYDROEPIANDROSTERONE) PREGNENOLONE, PROGESTERTONE, TESTOSTERONE) SPRAY [BIOACTIVE NUTRITIONAL, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RANDROBALANCE (DHEA (DEHYDROEPIANDROSTERONE) PREGNENOLONE, PROGESTERTONE, TESTOSTERONE) SPRAY [BIOACTIVE NUTRITIONAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0284ANDROBALANCE (DHEA (DEHYDROEPIANDROSTERONE) PREGNENOLONE, PROGESTERONE, TESTOSTERONE) SPRAY [BIOACTIVE NUTRITIONAL, INC.]4Current NDC, Legacy NDC, 1 package rows20230607_e231695a-165a-419e-b594-34f9522503ac.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AndrobalanceDHEA (DEHYDROEPIANDROSTERONE) PREGNENOLONE, PROGESTERONE, TESTOSTERONEBioActive Nutritional, Inc.e231695a-165a-419e-b594-34f9522503ac2025-12-18WarningsExact identifier
ndc (product): 43857-0284

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0284-14385702840130 mL in 1 BOTTLE, SPRAY (43857-0284-1) 30 ml2017-04-130000-00-00NoNoCurrent