Strength M

Product NDC
43857-0428
11-digit product format
438570428
Labeler code
43857
Product ID
43857-0428_e0d0fe1c-8497-4ce7-889f-1dcbd7a07397
Type
HUMAN OTC DRUG
Nonproprietary name
Aralia Quinquefolia, Avena Sativa, Damiana, Epimedium Grandiflorum, Glutathione, L-Arginine, L-Leucine, L-Ornithine, L-Valine, Testosterone, Sabal Serrulata, Sepia
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2017-01-19
Substance
AMERICAN GINSENG; ARGININE; AVENA SATIVA FLOWERING TOP; EPIMEDIUM GRANDIFLORUM TOP; GLUTATHIONE; LEUCINE; ORNITHINE; SAW PALMETTO; SEPIA OFFICINALIS JUICE; TESTOSTERONE; TURNERA DIFFUSA LEAFY TWIG; VALINE
Active strength
3; 6; 3; 6; 6; 6; 6; 24; 30; 12; 3; 6 [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]
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 · 22 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43857-0428-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43857-0428-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage43857-0428-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage43857-0428-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage43857-0428-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage43857-0428-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage43857-0428-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage43857-0428-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage43857-0428-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage43857-0428-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage43857-0428-19bebd1f3094a…5416666fcb17…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMERICAN GINSENG3 [hp_X]/mL
AVENA SATIVA FLOWERING TOP6 [hp_X]/mL
TURNERA DIFFUSA LEAFY TWIG3 [hp_X]/mL
EPIMEDIUM GRANDIFLORUM TOP6 [hp_X]/mL
GLUTATHIONE6 [hp_X]/mL
ARGININE6 [hp_X]/mL
LEUCINE6 [hp_X]/mL
ORNITHINE24 [hp_X]/mL
VALINE30 [hp_X]/mL
TESTOSTERONE12 [hp_X]/mL
SAW PALMETTO3 [hp_X]/mL
SEPIA OFFICINALIS JUICE6 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8W75VCV53QInternal UNII lookup
MA9CQJ3F7FInternal UNII lookup
RQ2CFA7WWJInternal UNII lookup
137PC46F89Internal UNII lookup
GAN16C9B8OInternal UNII lookup
94ZLA3W45FInternal UNII lookup
GMW67QNF9CInternal UNII lookup
E524N2IXA3Internal UNII lookup
HG18B9YRS7Internal UNII lookup
3XMK78S47OInternal UNII lookup
J7WWH9M8QSInternal UNII lookup
QDL83WN8C2Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8eda49aa-da6c-4e06-926c-73f35f33e5d8Available 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
93cc9bee-8bdc-273d-ec7f-c2c52535317aProduct name720210902
a6389cd1-36d1-4b5c-9934-1139bee93605Product name520210601
f4f0889f-ee8b-471f-9a37-02a035280637Product name120200122
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
96bdf4b3-71cd-433d-9723-89e50f852992Product name120150810
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
ed2e617f-f28a-1df1-f9fc-c79702f31271Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0428-12024-10-18C16284748780-19d75b9d0-c7ea-f424-e053-dadaa90a57ceDRUG FACTS:
43857-0428-12020-01-31C16284748780-19d75b9d0-c7ea-f424-e053-dadaa90a57ceDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0428-1Strength M30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0428STRENGTH M (ARALIA QUINQUEFOLIA, AVENA SATIVA, DAMIANA, EPIMEDIUM GRANDIFLORUM, GLUTATHIONE, L-ARGININE, L-LEUCINE, L-ORNITHINE, L-VALINE, TESTOSTERONE, SABAL SERRULATA, SEPIA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2Current NDC, Legacy NDC, 1 package rows20241020_8eda49aa-da6c-4e06-926c-73f35f33e5d8.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
Strength MARALIA QUINQUEFOLIA, AVENA SATIVA, DAMIANA, EPIMEDIUM GRANDIFLORUM, GLUTATHIONE, L-ARGININE, L-LEUCINE, L-ORNITHINE, L-VALINE, TESTOSTERONE, SABAL SERRULATA, SEPIABioActive Nutritional, Inc.8eda49aa-da6c-4e06-926c-73f35f33e5d82024-10-18WarningsExact identifier
ndc (product): 43857-0428

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43857-0428-14385704280130 mL in 1 BOTTLE, DROPPER (43857-0428-1) 30 ml2017-01-19NoNoCurrent