FDA.reportPublic FDA data

Strength M

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2024-10-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:28:17

Label at a glance#

ProductStrength M
Active ingredientAMERICAN GINSENG, AVENA SATIVA FLOWERING TOP, TURNERA DIFFUSA LEAFY TWIG, EPIMEDIUM GRANDIFLORUM TOP, GLUTATHIONE, ARGININE, LEUCINE, ORNITHINE, VALINE, TESTOSTERONE, SAW PALMETTO, SEPIA OFFICINALIS JUICE
Label structure9 sections

Dosage and administration

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Aralia Quinquefolia 3X, Avena Sativa 3X, Damiana 3X, Epimedium Grandiflorum 6X, Glutathione 6X, L-Arginine 6X, L-Leucine 6X, L-Ornithine 6X, L-Valine 6X, Testosterone 12X, Sabal Serrulata 24X, Sepia 30X.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of muscular exhaustion, debility after exercise and lowered vitality in the male after exercise.

WARNINGS:

WARNINGS SECTION

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

INDICAITONS:

INDICATIONS & USAGE SECTION

For temporary relief of muscular exhaustion, debility after exercise and lowered vitality in the male after exercise.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional

STRENGTH M

HOMEOPATHIC

1 FL OZ (30 ml)

Strenght MStrenght M

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-042843857-0428-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMERICAN GINSENG8W75VCV53QACTIB
AVENA SATIVA FLOWERING TOPMA9CQJ3F7FACTIB
TURNERA DIFFUSA LEAFY TWIGRQ2CFA7WWJACTIB
EPIMEDIUM GRANDIFLORUM TOP137PC46F89ACTIB
GLUTATHIONEGAN16C9B8OACTIB
ARGININE94ZLA3W45FACTIB
LEUCINEGMW67QNF9CACTIB
ORNITHINEE524N2IXA3ACTIB
VALINEHG18B9YRS7ACTIB
TESTOSTERONE3XMK78S47OACTIB
SAW PALMETTOJ7WWH9M8QSACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

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 (package): 43857-0428-1
ndc (product): 43857-0428
ndc11 (package): 43857042801
spl id: e0d0fe1c-8497-4ce7-889f-1dcbd7a07397
spl set id: 8eda49aa-da6c-4e06-926c-73f35f33e5d8

Reported adverse events (FAERS/openFDA)#

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