FDA.reportPublic FDA data

Adaptagen

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2026-03-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:38:04

Label at a glance#

ProductAdaptagen
Active ingredientAMERICAN GINSENG, AVENA SATIVA FLOWERING TOP, CAPSICUM, GINKGO, GLYCYRRHIZA GLABRA, CENTELLA ASIATICA, THIAMINE HYDROCHLORIDE, ASCORBIC ACID, RIBOFLAVIN, SUS SCROFA ADRENAL GLAND, SUS SCROFA SPLEEN, SUS SCROFA THYROID, COPPER GLUCONATE, IODINE, LEDUM PALUSTRE TWIG, MOLYBDENUM, SODIUM CARBONATE, PHOSPHORIC ACID, PICRIC ACID, SELENIUM, SEPIA OFFICINALIS JUICE, VANADIUM, ADENOSINE TRIPHOSPHATE DISODIUM
Label structure9 sections

Indications and uses

For temporary relief of tiredness, weakness, general fatigue, exhaustion, weakness of memory.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Dosage and administration

• 10 drops orally, 3 times a day or as directed by a health care professional. • Consult a health care professional for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Aralia Quinquefolia 3X, Ascorbicum Acidum 6X, Adenosinum Triphosphoricum Dinatrum 30X, Avena Sativa 3X, Capsicum Annuum 3X, Copper Gluconate 12X, Ginkgo Biloba 3X, Glandula Suprarenalis Suis 8X, Glycyrrhiza Glabra 3X, Hydrocotyle Asiatica 3X, Iodium 12X, Ledum Palustre 12X, Molybdenum Metallicum 12X, Natrum Carbonicum 12X, Phosphoricum Acidum 12X, Picricum Acidum 12X, Riboflavinum 6X, Selenium Metallicum 12X, Sepia 12X, Spleen 8X, Thiaminum Hydrochloricum 4X, Thyroidinum 8X, Vanadium Metallicum 12X.

PURPOSE:

OTC - PURPOSE SECTION

Aralia Quinquefolia – low back pain,** Ascorbicum Acidum - fatigue,** ATP– memory problems,** Avena Sativa – nervous exhaustion,** Capsicum Annuum - weakness,** Copper Gluconate – liver discomfort,** Ginkgo Biloba – memory problems,** Glandula Suprarenalis Suis - fatigue,** Glycyrrhiza Glabra - fatigue,** Hydrocotyle Asiatica - tiredness,** Iodium - debility,** Ledum Palustre – joint pain,** Molybdenum Metallicum – muscle cramps,** Natrum Carbonicum - sleeplessness,** Phosphoricum Acidum - headache,** Picricum Acidum - confusion,** Riboflavinum – supports the brain,** Selenium Metallicum – muscle weakness,** Sepia - weakness,** Spleen - weakness,** Thiaminum Hydrochloricum - forgetfulness,** Thyroidinum - fatigue,** Vanadium Metallicum – fatigue**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

USES:

INDICATIONS & USAGE SECTION

For temporary relief of tiredness, weakness, general fatigue, exhaustion, weakness of memory.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

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 a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 or as directed by a health care professional.

• Consult a health care professional for use in children under 12 years of age.

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

1-800-288-9525

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional

ADAPTAGEN

HOMEOPATHIC

1 fl. oz. (30 mL

ADAPTAGENADAPTAGEN

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0506-12024-10-02C16284748780-1ba0f9c33-42b1-a910-e053-dadaa90a0b85DRUG FACTS:
43857-0506-12021-01-29C16284748780-1ba0f9c33-42b1-a910-e053-dadaa90a0b85DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0506-1Adaptagen30 mL in 1 BOTTLE, DROPPERLIQUID303

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-050643857-0506-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMERICAN GINSENG8W75VCV53QACTIB
AVENA SATIVA FLOWERING TOPMA9CQJ3F7FACTIB
CAPSICUM00UK7646FGACTIB
GINKGO19FUJ2C58TACTIB
GLYCYRRHIZA GLABRA2788Z9758HACTIB
CENTELLA ASIATICA7M867G6T1UACTIB
THIAMINE HYDROCHLORIDEM572600E5PACTIB
ASCORBIC ACIDPQ6CK8PD0RACTIB
RIBOFLAVINTLM2976OFRACTIB
SUS SCROFA ADRENAL GLAND398IYQ16YVACTIB
SUS SCROFA SPLEEN92AMN5J79YACTIB
SUS SCROFA THYROID6RV024OAUQACTIB
COPPER GLUCONATERV823G6G67ACTIM
IODINE9679TC07X4ACTIB
LEDUM PALUSTRE TWIG877L01IZ0PACTIB
MOLYBDENUM81AH48963UACTIB
SODIUM CARBONATE45P3261C7TACTIB
PHOSPHORIC ACIDE4GA8884NNACTIB
PICRIC ACIDA49OS0F91SACTIB
SELENIUMH6241UJ22BACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
VANADIUM00J9J9XKDEACTIB
ADENOSINE TRIPHOSPHATE DISODIUM5L51B4DR1GACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML · Source PDF

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
AdaptagenARALIA QUINQUEFOLIA, AVENA SATIVA, CAPSICUM ANNUUM, GINKGO BILOBA, GLYCYRRHIZA GLABRA, HYDROCOTYLE ASIATICA, THIAMINUM HYDROCHLORICUM, ASCORBICUM ACIDUM, RIBOFLAVINUM, GLANDULA SUPRARENALIS SUIS, SPLEEN (SUIS), THYROIDINUM (SUIS), CUPRUM GLUCONATE, IODIUM, LEDUM PALUSTRE, MOLYBDENUM METALLICUM, NATRUM CARBONICUM, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, SELENIUM METALLICUM, SEPIA, VANADIUM METALLICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUMBioActive Nutritional, Inc.9404d71c-8a2e-4e68-bf48-8536bb14fc882026-03-18WarningsExact identifier
ndc (package): 43857-0506-1
ndc (product): 43857-0506
ndc11 (package): 43857050601
spl id: 5874bc82-7249-44fb-8d4a-c9ee14233c9e
spl set id: 9404d71c-8a2e-4e68-bf48-8536bb14fc88

Reported adverse events (FAERS/openFDA)#

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