FDA.reportPublic FDA data

DHEA Forte

Product NDC
43857-0052
11-digit product format
438570052
Labeler code
43857
Product ID
43857-0052_b7e4c39c-d2eb-49f4-8411-63a44fe87684
Type
HUMAN OTC DRUG
Nonproprietary name
Dehydroepiandrosterone (DHEA), Pregnenolone, Progesterone,
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritionals, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2012-08-07
Substance
PRASTERONE; PREGNENOLONE; PROGESTERONE
Active strength
6; 6; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Progesterone [CS], Progesterone [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DHEA Forte
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRASTERONE6 [hp_X]/mL
PREGNENOLONE6 [hp_X]/mL
PROGESTERONE6 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii459AG36T1B, 73R90F7MQ8, 4G7DS2Q64Y

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b46148e2-ee15-98d5-12f0-f5ec8745f6fcProduct name320220927
76820076-f087-4073-b1d1-aa04b361335eProduct name220220921
d3229c1a-4e51-4e04-9b13-00d24fd35242Product name120200821
213f0591-95c1-b398-40b7-08b31f66b026Product name420190206
86ca2ee7-106a-420e-9137-a9ec1af5dbc1Product name120170110
85b2d644-53b2-f2dc-4dbc-859116ce56c0Product name120140508
d048f0e3-3c40-8816-8c5c-0ca5cd189aacProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0052-1DHEA Forte30 mL in 1 BOTTLE, SPRAYLIQUID306

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRASTERONEACTIVE INGREDIENT459AG36T1BDHEA FORTE (DEHYDROEPIANDROSTERONE (DHEA), PREGNENOLONE, PROGESTERONE,) LIQUID [BIOACTIVE NUTRITIONALS, INC.]2
PREGNENOLONEACTIVE INGREDIENT73R90F7MQ8DHEA FORTE (DEHYDROEPIANDROSTERONE (DHEA), PREGNENOLONE, PROGESTERONE,) LIQUID [BIOACTIVE NUTRITIONALS, INC.]2
PROGESTERONEACTIVE INGREDIENT4G7DS2Q64YDHEA FORTE (DEHYDROEPIANDROSTERONE (DHEA), PREGNENOLONE, PROGESTERONE,) LIQUID [BIOACTIVE NUTRITIONALS, INC.]2
PRASTERONEACTIVE MOIETY459AG36T1BDHEA FORTE (DEHYDROEPIANDROSTERONE (DHEA), PREGNENOLONE, PROGESTERONE,) LIQUID [BIOACTIVE NUTRITIONALS, INC.]2
PREGNENOLONEACTIVE MOIETY73R90F7MQ8DHEA FORTE (DEHYDROEPIANDROSTERONE (DHEA), PREGNENOLONE, PROGESTERONE,) LIQUID [BIOACTIVE NUTRITIONALS, INC.]2
PROGESTERONEACTIVE MOIETY4G7DS2Q64YDHEA FORTE (DEHYDROEPIANDROSTERONE (DHEA), PREGNENOLONE, PROGESTERONE,) LIQUID [BIOACTIVE NUTRITIONALS, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDHEA FORTE (DEHYDROEPIANDROSTERONE (DHEA), PREGNENOLONE, PROGESTERONE,) LIQUID [BIOACTIVE NUTRITIONALS, INC.]2
GlycerinINACTIVE INGREDIENTPDC6A3C0OXDHEA FORTE (DEHYDROEPIANDROSTERONE (DHEA), PREGNENOLONE, PROGESTERONE,) LIQUID [BIOACTIVE NUTRITIONALS, INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUDHEA FORTE (DEHYDROEPIANDROSTERONE (DHEA), PREGNENOLONE, PROGESTERONE,) LIQUID [BIOACTIVE NUTRITIONALS, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RDHEA FORTE (DEHYDROEPIANDROSTERONE (DHEA), PREGNENOLONE, PROGESTERONE,) LIQUID [BIOACTIVE NUTRITIONALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0052DHEA FORTE (DEHYDROEPIANDROSTERONE (DHEA), PREGNENOLONE, PROGESTERONE,) LIQUID [BIOACTIVE NUTRITIONALS, INC.]4Current NDC, Legacy NDC, 1 package rows20211210_663affc1-0998-4231-b284-ff3e2a7807b9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0052-14385700520130 mL in 1 BOTTLE, SPRAY (43857-0052-1) 30 ml2016-03-150000-00-00NoNoCurrent