FDA.reportPublic FDA data

Metabolism

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2024-10-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:28:14

Label at a glance#

ProductMetabolism
Active ingredientBERBERIS VULGARIS ROOT BARK, GLYCYRRHIZA GLABRA, ARCTIUM LAPPA ROOT, FRANGULA PURSHIANA BARK, TRIFOLIUM PRATENSE FLOWER, ZANTHOXYLUM AMERICANUM BARK, ASCORBIC ACID, METHYLCOBALAMIN, RIBOFLAVIN, THIAMINE HYDROCHLORIDE, GERMANIUM SESQUIOXIDE, CYSTEINE, MANGANESE GLUCONATE, ADENOSINE TRIPHOSPHATE DISODIUM, .ALPHA.-KETOGLUTARIC ACID, FUMARIC ACID, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM DIETHYL OXALACETATE, PULSATILLA VULGARIS WHOLE, PYRUVIC ACID, UBIDECARENONE, CALCIUM SULFIDE
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

Berberis Vulgaris 3X, Glycyrrhiza Glabra 3X, Lappa Major 3X, Rhamnus Purshiana 3X, Trifolium Pratense 3X, Xanthoxylum Fraxineum 3X, Ascorbic Acid 6X, Methylcobalamin 6X, Riboflavinum 6X, Thiaminum Hydrochloricum 6X, Germanium Sesquioxide 8X, Cysteinum 9X, Manganese Gluconate 10X, Adenosinum Triphosphoricum Dinatrum 12X, Alpha-Ketoglutaricum Acidum 12X, Fumaricum Acidum 12X, Magnesia Phosphorica 12X, Natrum Oxalaceticum 12X, Pulsatilla (Vulgaris) 12X, Pyruvic Acid 12X, Ubidecarenonum 12X, Hepar Sulphuris Calcareum 30X.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of fatigue, exhaustion, and lowered metabolism.

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

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.

INDICATIONS:

INDICATIONS & USAGE SECTION

For temporary relief of fatigue, exhaustion, and lowered metabolism.

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 DISPLAY LABEL:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional

METABOLISM

HOMEOPATHIC

1 FL OZ (30 ml)

MetabolismMetabolism

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0587-12024-10-17C16284748780-1f386c649-c352-0266-e053-dadaa90a7c1aDRUG FACTS:
43857-0587-12023-01-30C16284748780-1f386c649-c352-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0587-1Metabolism30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0587METABOLISM (BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS PURSHIANA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, ASCORBICUM ACIDUM, METHYLCOBALAMIN, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, GERMANIUM SESQUIOXIDE, CYSTEINUM, MANGANESE GLUCONATE, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, FUMARICUM ACIDUM, MAGNESIA PHOSPHORICA, NATRUM OXALACETICUM, PULSATILLA (VULGARIS), PYRUVIC ACID, UBIDECARENONUM, HEPAR SULPHURIS CALCAREUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2Current NDC, Legacy NDC, 1 package rows20241019_76f70259-44b1-467a-bff4-b427ddfe3abd.zip

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-058743857-0587-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
GLYCYRRHIZA GLABRA2788Z9758HACTIB
ARCTIUM LAPPA ROOT597E9BI3Z3ACTIB
FRANGULA PURSHIANA BARK4VBP01X99FACTIB
TRIFOLIUM PRATENSE FLOWER4JS0838828ACTIB
ZANTHOXYLUM AMERICANUM BARKA4KL1HMZ7TACTIB
ASCORBIC ACIDPQ6CK8PD0RACTIB
METHYLCOBALAMINBR1SN1JS2WACTIB
RIBOFLAVINTLM2976OFRACTIB
THIAMINE HYDROCHLORIDEM572600E5PACTIB
GERMANIUM SESQUIOXIDE96WE91N25TACTIB
CYSTEINEK848JZ4886ACTIB
MANGANESE GLUCONATE9YY2F980SVACTIB
ADENOSINE TRIPHOSPHATE DISODIUM5L51B4DR1GACTIB
.ALPHA.-KETOGLUTARIC ACID8ID597Z82XACTIB
FUMARIC ACID88XHZ13131ACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHF539G9L3QACTIB
SODIUM DIETHYL OXALACETATE6CA025Y4FGACTIB
PULSATILLA VULGARIS WHOLEI76KB35JEVACTIB
PYRUVIC ACID8558G7RUTRACTIB
UBIDECARENONEEJ27X76M46ACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
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
MetabolismBERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS PURSHIANA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, ASCORBICUM ACIDUM, METHYLCOBALAMIN, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, GERMANIUM SESQUIOXIDE, CYSTEINUM, MANGANESE GLUCONATE, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, FUMARICUM ACIDUM, MAGNESIA PHOSPHORICA, NATRUM OXALACETICUM, PULSATILLA (VULGARIS), PYRUVIC ACID, UBIDECARENONUM, HEPAR SULPHURIS CALCAREUMBioActive Nutritional, Inc.76f70259-44b1-467a-bff4-b427ddfe3abd2024-10-17WarningsExact identifier
ndc (package): 43857-0587-1
ndc (product): 43857-0587
ndc11 (package): 43857058701
spl id: 10f899a8-81c7-4103-a261-ebd8942e36ab
spl set id: 76f70259-44b1-467a-bff4-b427ddfe3abd

Reported adverse events (FAERS/openFDA)#

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