Male Balance

Product NDC
44911-0613
11-digit product format
449110613
Labeler code
44911
Product ID
44911-0613_6b4ae3c0-cbfb-40cf-965f-e4bd2b961a2d
Type
HUMAN OTC DRUG
Nonproprietary name
Avena Sativa, Hepar Suis, Orchitinum (Suis), Testosterone, Agnus Castus, Damiana, Ginkgo Biloba, Hypothalamus (Suis), Lycopodium Clabatum, Human Growth Hormone, Epimedium Grandiflorum, Serotonin (Hydrochloride)
Dosage form
LIQUID
Route
ORAL
Labeler
Energique,Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-05-25
Substance
AVENA SATIVA FLOWERING TOP; CHASTE TREE FRUIT; EPIMEDIUM GRANDIFLORUM TOP; GINKGO; LYCOPODIUM CLAVATUM SPORE; PORK LIVER; SEROTONIN HYDROCHLORIDE; SOMATROPIN; SUS SCROFA HYPOTHALAMUS; SUS SCROFA TESTICLE; TESTOSTERONE; TURNERA DIFFUSA LEAFY TWIG
Active strength
6; 12; 30; 12; 12; 6; 30; 26; 12; 6; 6; 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; [hp_X]/mL
Pharmacologic classes
Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS], Human Growth Hormone [CS], Recombinant Human Growth Hormone [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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct44911-0613IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage44911-061344911-0613-1IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVENA SATIVA FLOWERING TOP6 [hp_X]/mL
PORK LIVER12 [hp_X]/mL
SUS SCROFA TESTICLE30 [hp_X]/mL
TESTOSTERONE12 [hp_X]/mL
CHASTE TREE FRUIT12 [hp_X]/mL
TURNERA DIFFUSA LEAFY TWIG6 [hp_X]/mL
GINKGO30 [hp_X]/mL
SUS SCROFA HYPOTHALAMUS26 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE12 [hp_X]/mL
SOMATROPIN6 [hp_X]/mL
EPIMEDIUM GRANDIFLORUM TOP6 [hp_X]/mL
SEROTONIN HYDROCHLORIDE12 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MA9CQJ3F7FInternal UNII lookup
6EC706HI7FInternal UNII lookup
KM02613O28Internal UNII lookup
3XMK78S47OInternal UNII lookup
433OSF3U8AInternal UNII lookup
RQ2CFA7WWJInternal UNII lookup
19FUJ2C58TInternal UNII lookup
N6R0856Z79Internal UNII lookup
C88X29Y479Internal UNII lookup
NQX9KB6PCLInternal UNII lookup
137PC46F89Internal UNII lookup
GKN429M9VSInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
297fe55b-ac23-4a7f-bbbe-1005c0066931Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2db4fc38-a116-b0ab-3dae-57df54e5f212Product name220250121
79c101e4-e5e3-43d7-be20-f7477d1e7556Product name120241230
386d1b2a-e9b7-0c83-111f-2a77b92895b3Product name520240422
7d55b53c-798b-47ae-992b-3921493a8303Product name120230322
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
8d753fd6-75b2-4f12-bcbf-339392960afaProduct name120230303
4fbda828-a5be-46fe-83ec-a88da4359919Product name120230104
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
93cc9bee-8bdc-273d-ec7f-c2c52535317aProduct name720210902
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
a6389cd1-36d1-4b5c-9934-1139bee93605Product name520210601
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
34b7b043-6d89-4d95-9bed-7f5f2b49e6efProduct name220200325
37e0ae3d-ccb0-0ec8-fae8-e1f0917a8a04Product name220200325
739a54c2-5f56-495a-aa67-4295fbc1cc86Product name220200325
f4f0889f-ee8b-471f-9a37-02a035280637Product name120200122
09e1afd3-f431-4380-82c5-438884c25615Product name120190111
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
a6389cd1-36d1-4b5c-9934-1139bee93605Product name320171212
502efed8-01a5-ef6a-61c6-fe8302b6e26bProduct name220171113
8b700cfd-17dd-41a2-90f5-a80ae8a989a2Product name120171113
9ce0e503-4ae7-2c6a-39ae-85285c29db68Product name220171113
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
96bdf4b3-71cd-433d-9723-89e50f852992Product name120150810
ed2e617f-f28a-1df1-f9fc-c79702f31271Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0613-12024-04-26C16284748780-1f386c649-b23a-0266-e053-dadaa90a7c1aDRUG FACTS
44911-0613-12023-01-30C16284748780-1f386c649-b23a-0266-e053-dadaa90a7c1aDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0613-1Male Balance30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0613MALE BALANCE (AVENA SATIVA, HEPAR SUIS, ORCHITINUM (SUIS), TESTOSTERONE, AGNUS CASTUS, DAMIANA, GINKGO BILOBA, HYPOTHALAMUS (SUIS), LYCOPODIUM CLABATUM, HUMAN GROWTH HORMONE, EPIMEDIUM GRANDIFLORUM, SEROTONIN (HYDROCHLORIDE)) LIQUID [ENERGIQUE,INC.]2Current NDC, Legacy NDC, 1 package rows20240427_297fe55b-ac23-4a7f-bbbe-1005c0066931.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
Male BalanceAVENA SATIVA, HEPAR SUIS, ORCHITINUM (SUIS), TESTOSTERONE, AGNUS CASTUS, DAMIANA, GINKGO BILOBA, HYPOTHALAMUS (SUIS), LYCOPODIUM CLABATUM, HUMAN GROWTH HORMONE, EPIMEDIUM GRANDIFLORUM, SEROTONIN (HYDROCHLORIDE)Energique,Inc.297fe55b-ac23-4a7f-bbbe-1005c00669312024-04-26WarningsExact identifier
ndc (product): 44911-0613

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0613-14491106130130 mL in 1 BOTTLE, DROPPER (44911-0613-1) 30 ml2021-05-250000-00-00NoNoCurrent