FDA.reportPublic FDA data

Occuloplex G

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2024-05-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:26:51

Label at a glance#

ProductOcculoplex G
Active ingredientEUPHRASIA STRICTA, GINKGO, PETROSELINUM CRISPUM WHOLE, BILBERRY, ASCORBIC ACID, SPIGELIA ANTHELMIA WHOLE, SUS SCROFA EYE, GERMANIUM SESQUIOXIDE, UBIDECARENONE, GOLD, BRYONIA ALBA ROOT, CALCIUM SULFIDE, PHOSPHORUS, RUTA GRAVEOLENS FLOWERING TOP, SULFUR, LITHIUM
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

Euphrasia Officinalis 3X, Ginkgo Biloba 3X, Petroselinum Sativum 3X, Vaccinium Myrtillus 3X, Ascorbic Acid 6X, Spigelia Anthelmia 6X, Eye (Suis) 6X, 9X, Germanium Sesquioxide 8X, Ubidecarenonum 8X, Aurum Metallicum 12X, Bryonia (Alba) 12X, Hepar Sulphuris Calcareum 12X, Phosphorus 12X, Ruta Graveolens 12X, Sulphur 12X, Lithium Metallicum 14X.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of pressure in the eyes, and pain in and around the eyes.

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 pressure in the eyes, and pain in and around the eyes.

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

OCCULOPLEX G

HOMEOPATHIC

1 FL OZ (30 ml)

Occuloplex GOcculoplex G

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3053bb1-353b-4a0b-bca5-28fe7228957cProduct name220250124
8ce6e144-236f-b7be-f690-f06e0c8c6bd3Product name220170725
f09af6ee-c6dd-d0ce-77ad-93508bcdacedProduct name420161205

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0513-12024-05-02C16284748780-1ba0f9c33-5973-a910-e053-dadaa90a0b85DRUG FACTS:
43857-0513-12021-01-29C16284748780-1ba0f9c33-5973-a910-e053-dadaa90a0b85DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0513-1Occuloplex G30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0513OCCULOPLEX G (EUPHRASIA OFFICINALIS, GINKGO BILOBA, PETROSELINUM SATIVUM, VACCINIUM MYRTILLUS, ASCORBICUM ACIDUM, SPIGELIA ANTHELMIA, EYE (SUIS), GERMANIUM SESQUIOXIDE, UBIDECARENONUM, AURUM METALLICUM, BRYONIA (ALBA), HEPAR SULPHURIS CALCAREUM, PHOSPHORUS, RUTA GRAVEOLENS, SULPHUR, LITHIUM METALLICUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2Current NDC, Legacy NDC, 1 package rows20240504_c982e701-129c-4b55-b8e6-ff0517838492.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-051343857-0513-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
EUPHRASIA STRICTAC9642I91WLACTIB
GINKGO19FUJ2C58TACTIB
PETROSELINUM CRISPUM WHOLE1WZA4Y92EXACTIB
BILBERRY9P2U39H18WACTIB
ASCORBIC ACIDPQ6CK8PD0RACTIB
SPIGELIA ANTHELMIA WHOLEWYT05213GEACTIB
SUS SCROFA EYEX3AOK514E6ACTIB
GERMANIUM SESQUIOXIDE96WE91N25TACTIB
UBIDECARENONEEJ27X76M46ACTIB
GOLD79Y1949PYOACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
PHOSPHORUS27YLU75U4WACTIB
RUTA GRAVEOLENS FLOWERING TOPN94C2U587SACTIB
SULFUR70FD1KFU70ACTIB
LITHIUM9FN79X2M3FACTIB
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
Occuloplex GEUPHRASIA OFFICINALIS, GINKGO BILOBA, PETROSELINUM SATIVUM, VACCINIUM MYRTILLUS, ASCORBICUM ACIDUM, SPIGELIA ANTHELMIA, EYE (SUIS), GERMANIUM SESQUIOXIDE, UBIDECARENONUM, AURUM METALLICUM, BRYONIA (ALBA), HEPAR SULPHURIS CALCAREUM, PHOSPHORUS, RUTA GRAVEOLENS, SULPHUR, LITHIUM METALLICUMBioActive Nutritional, Inc.c982e701-129c-4b55-b8e6-ff05178384922024-05-02WarningsExact identifier
ndc (package): 43857-0513-1
ndc (product): 43857-0513
ndc11 (package): 43857051301
spl id: c74fbdf1-ce96-46a3-a054-6a2f1113805e
spl set id: c982e701-129c-4b55-b8e6-ff0517838492

Reported adverse events (FAERS/openFDA)#

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