FDA.reportPublic FDA data

Food Additives

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2016-09-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:08:10

Label at a glance#

ProductFood Additives
Active ingredientBERBERIS VULGARIS ROOT BARK, CHELIDONIUM MAJUS, TRIFOLIUM PRATENSE FLOWER, GLYCYRRHIZA GLABRA, ARCTIUM LAPPA ROOT, PHYTOLACCA AMERICANA ROOT, FRANGULA ALNUS BARK, FRANGULA PURSHIANA BARK, STILLINGIA SYLVATICA ROOT, ZANTHOXYLUM AMERICANUM BARK, ARSENIC TRIOXIDE, ATROPA BELLADONNA WHOLE, LYCOPODIUM CLAVATUM SPORE, SODIUM SULFATE, PHOSPHORIC ACID
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, Chelidonium Majus 3X, Trifolium Pratense 3X, Glycyrrhiza Glabra 4X, Lappa Major 4X, Phytolacca Decandra 4X, Rhamnus Frangula 4X, Rhamnus Purshiana 4X, Stillingia Sylvatica 4X, Xanthoxylum Fraxineum 4X, Arsenicum Album 12X, Belladonna 12X, Lycopodium Clavatum 12X, Natrum Sulphuricum 12X, Phosphoricum Acidum 12X

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of exhaustion, flatulence and mood swings. 

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.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol.

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.

INDICATIONS:

INDICATIONS & USAGE SECTION

For temporary relief of exhaustion, flatulence and mood swings.

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

FOOD ADDITIVES

HOMEOPATHIC

1 FL OZ (30 ml)

Food AdditivesFood Additives

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0168-1Food Additives30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0168FOOD ADDITIVES (BERBERIS VULGARIS, CHELIDONIUM MAJUS, TRIFOLIUM PRATENSE, GLYCYRRHIZA GLABRA, LAPPA MAJOR, PHYTOLACCA DECANDRA, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, XANTHOXYLUM FRAXINEUM, ARSENICUM ALBUM, BELLADONNA, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2Current NDC, Legacy NDC, 1 package rows20160929_bf27d457-12e1-4ab6-b132-1b65cde0ed93.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARCTIUM LAPPA ROOTACTIVE INGREDIENT597E9BI3Z31
ARSENIC TRIOXIDEACTIVE INGREDIENTS7V92P67HO1
ATROPA BELLADONNA WHOLEACTIVE INGREDIENTDSV74G1P2J1
BERBERIS VULGARIS ROOT BARKACTIVE INGREDIENT1TH8Q20J0U1
CHELIDONIUM MAJUSACTIVE INGREDIENT7E889U5RNN1
FRANGULA ALNUS BARKACTIVE INGREDIENTS2D77IH61R1
FRANGULA PURSHIANA BARKACTIVE INGREDIENT4VBP01X99F1
GLYCYRRHIZA GLABRAACTIVE INGREDIENT2788Z9758H1
LYCOPODIUM CLAVATUM SPOREACTIVE INGREDIENTC88X29Y4791
PHOSPHORIC ACIDACTIVE INGREDIENTE4GA8884NN1
PHYTOLACCA AMERICANA ROOTACTIVE INGREDIENT11E6VI8VEG1
SODIUM SULFATEACTIVE INGREDIENT0YPR65R21J1
STILLINGIA SYLVATICA ROOTACTIVE INGREDIENTQBR70R4FBK1
TRIFOLIUM PRATENSE FLOWERACTIVE INGREDIENT4JS08388281
ZANTHOXYLUM AMERICANUM BARKACTIVE INGREDIENTA4KL1HMZ7T1
ARCTIUM LAPPA ROOTACTIVE MOIETY597E9BI3Z31
ARSENIC CATION (3+)ACTIVE MOIETYC96613F5AV1
ATROPA BELLADONNA WHOLEACTIVE MOIETYDSV74G1P2J1
BERBERIS VULGARIS ROOT BARKACTIVE MOIETY1TH8Q20J0U1
CHELIDONIUM MAJUSACTIVE MOIETY7E889U5RNN1
FRANGULA ALNUS BARKACTIVE MOIETYS2D77IH61R1
FRANGULA PURSHIANA BARKACTIVE MOIETY4VBP01X99F1
GLYCYRRHIZA GLABRAACTIVE MOIETY2788Z9758H1
LYCOPODIUM CLAVATUM SPOREACTIVE MOIETYC88X29Y4791
PHOSPHORIC ACIDACTIVE MOIETYE4GA8884NN1
PHYTOLACCA AMERICANA ROOTACTIVE MOIETY11E6VI8VEG1
SODIUM SULFATE ANHYDROUSACTIVE MOIETY36KCS0R7501
STILLINGIA SYLVATICA ROOTACTIVE MOIETYQBR70R4FBK1
TRIFOLIUM PRATENSE FLOWERACTIVE MOIETY4JS08388281
ZANTHOXYLUM AMERICANUM BARKACTIVE MOIETYA4KL1HMZ7T1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-016843857-0168-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
CHELIDONIUM MAJUS7E889U5RNNACTIB
TRIFOLIUM PRATENSE FLOWER4JS0838828ACTIB
GLYCYRRHIZA GLABRA2788Z9758HACTIB
ARCTIUM LAPPA ROOT597E9BI3Z3ACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
FRANGULA ALNUS BARKS2D77IH61RACTIB
FRANGULA PURSHIANA BARK4VBP01X99FACTIB
STILLINGIA SYLVATICA ROOTQBR70R4FBKACTIB
ZANTHOXYLUM AMERICANUM BARKA4KL1HMZ7TACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
ATROPA BELLADONNA WHOLEDSV74G1P2JACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
SODIUM SULFATE0YPR65R21JACTIB
PHOSPHORIC ACIDE4GA8884NNACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
Food AdditivesBERBERIS VULGARIS, CHELIDONIUM MAJUS, TRIFOLIUM PRATENSE, GLYCYRRHIZA GLABRA, LAPPA MAJOR, PHYTOLACCA DECANDRA, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, XANTHOXYLUM FRAXINEUM, ARSENICUM ALBUM, BELLADONNA, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUMBioActive Nutritional, Inc.bf27d457-12e1-4ab6-b132-1b65cde0ed932016-09-28WarningsExact identifier
ndc (package): 43857-0168-1
ndc (product): 43857-0168
ndc11 (package): 43857016801
spl id: 4af75847-5944-45b7-95d6-efa3369c29ab
spl set id: bf27d457-12e1-4ab6-b132-1b65cde0ed93

Reported adverse events (FAERS/openFDA)#

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