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

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
ARGININE6 [hp_X]/mL
AVENA SATIVA FLOWERING TOP3 [hp_X]/mL
EPIMEDIUM GRANDIFLORUM TOP6 [hp_X]/mL
GLUTATHIONE6 [hp_X]/mL
LEUCINE6 [hp_X]/mL
ORNITHINE6 [hp_X]/mL
SAW PALMETTO24 [hp_X]/mL
SEPIA OFFICINALIS JUICE30 [hp_X]/mL
TESTOSTERONE12 [hp_X]/mL
TURNERA DIFFUSA LEAFY TWIG3 [hp_X]/mL
VALINE6 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8W75VCV53Q, 94ZLA3W45F, MA9CQJ3F7F, 137PC46F89, GAN16C9B8O, GMW67QNF9C, E524N2IXA3, J7WWH9M8QS, QDL83WN8C2, 3XMK78S47O, RQ2CFA7WWJ, HG18B9YRS7

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

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