FDA.reportPublic FDA data

FNG

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2025-10-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:37:02

Label at a glance#

ProductFNG I
Active ingredientECHINACEA ANGUSTIFOLIA WHOLE, LOMATIUM DISSECTUM ROOT, NASTURTIUM OFFICINALE, TABEBUIA IMPETIGINOSA BARK, MARSDENIA CONDURANGO BARK, GINKGO, LIGUSTICUM PORTERI ROOT, GOLDENSEAL, ASTRAGALUS PROPINQUUS ROOT, PROPOLIS WAX, BOS TAURUS ADRENAL GLAND, BOS TAURUS THYMUS, LYCOPODIUM CLAVATUM SPORE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORIC ACID, PHYTOLACCA AMERICANA ROOT, SEPIA OFFICINALIS JUICE, ALTERNARIA ALTERNATA, ASPERGILLUS NIGER VAR. NIGER, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, SACCHAROMYCES CEREVISIAE, MUCOR RACEMOSUS, RHIZOPUS STOLONIFER
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

Echinacea (Angustifolia) 3X, Lomatium Dissectum 3X, Nasturtium Aquaticum 3X, Tabebuia Impetiginosa 3X, Condurango 4X, Ginkgo Biloba 4X, Ligusticum Porteri 4X, Hydrastis Canadensis 5X, Astragalus Membranaceus 6X, Propolis 6X, Glandula Suprarenalis Bovine 8X, Thymus (Bovine) 8X, Lycopodium Clavatum 12X, Nux Vomica 12X, Phosphoricum Acidum 12X, Phytolacca Decandra 12X, Sepia 12X, Alternaria Tenuis Nees 30X, 200X, Aspergillus Niger 30X, 200X, Candida Albicans 30X, 200X, Candida Parapsilosis 30X, 200X, Torula Cerevisiae 30X, 200X, Mucor Racemosus 30X, 200X, Rhizopus Nigricans 30C, 200C.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of bloating of the bowels, heartburn, and intolerance of dried fruits.

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

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 bloating of the bowels, heartburn, and intolerance of dried fruits.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol

QUESITONS:

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

FNG I

HOMEOPATHIC

1 FL OZ (30 ml)

FNG IFNG I

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0594-12023-08-22C16284748780-1f386c64a-2482-0266-e053-dadaa90a7c1aDRUG FACTS:
43857-0594-12023-08-22C16284748780-1f386c64a-2482-0266-e053-dadaa90a7c1aDRUG FACTS:
43857-0594-12023-01-30C16284748780-1f386c64a-2482-0266-e053-dadaa90a7c1aDRUG FACTS:
43857-0594-12023-01-30C16284748780-1f386c64a-2482-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0594-1FNGI30 mL in 1 BOTTLE, DROPPERLIQUID303

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-059443857-0594-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
ECHINACEA ANGUSTIFOLIA WHOLEVB06AV5US8ACTIB
LOMATIUM DISSECTUM ROOT5329928G5NACTIB
NASTURTIUM OFFICINALEYH89GMV676ACTIB
TABEBUIA IMPETIGINOSA BARK6GLA1946WXACTIB
MARSDENIA CONDURANGO BARKR23QIR6YBAACTIB
GINKGO19FUJ2C58TACTIB
LIGUSTICUM PORTERI ROOT81FGO4H42JACTIB
GOLDENSEALZW3Z11D0JVACTIB
ASTRAGALUS PROPINQUUS ROOT922OP8YUPFACTIB
PROPOLIS WAX6Y8XYV2NOFACTIB
BOS TAURUS ADRENAL GLANDM2776SWB29ACTIB
BOS TAURUS THYMUS8XEJ88V2T8ACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PHOSPHORIC ACIDE4GA8884NNACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
ALTERNARIA ALTERNATA52B29REC7HACTIB
ASPERGILLUS NIGER VAR. NIGER9IOA40ANG6ACTIB
CANDIDA ALBICANS4D7G21HDBCACTIB
CANDIDA PARAPSILOSIS0KZ676D44NACTIB
SACCHAROMYCES CEREVISIAE978D8U419HACTIB
MUCOR RACEMOSUS17RH99LQ7GACTIB
RHIZOPUS STOLONIFERFEE198DK4QACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22023-08-22full-release2026-06-01 02:22:05

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
FNG IECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, NASTURTIUM AQUATICUM, TABEBUIA IMPETIGINOSA, CONDURANGO, GINKGO BILOBA, LIGUSTICUM PORTERI, HYDRASTIS CANADENSIS, ASTRAGALUS MEMBRANACEUS, PROPOLIS, GLANDULA SUPRARENALIS BOVINE, THYMUS (BOVINE), LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHYTOLACCA DECANDRA, SEPIA, ALTERNARIA TENUIS NEES, ASPERGILLUS NIGER, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, TORULA CEREVISIAE, MUCOR RACEMOSUS, RHIZOPUS NIGRICANS.BioActive Nutritional, Inc.c3dfd199-ac9b-450f-9459-721e100fa56a2025-10-06WarningsExact identifier
ndc (package): 43857-0594-1
ndc (product): 43857-0594
ndc11 (package): 43857059401
spl id: 972abb5a-a16f-4ef2-8bd4-5ee68ce6b7b2
spl set id: c3dfd199-ac9b-450f-9459-721e100fa56a

Reported adverse events (FAERS/openFDA)#

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