FDA.reportPublic FDA data

Occuloplex

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2024-05-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:26:54

Label at a glance#

ProductOcculoplex I
Active ingredientEUPHRASIA STRICTA, GINKGO, TARAXACUM OFFICINALE, GOLDENSEAL, GLUTATHIONE, UBIDECARENONE, ZINC GLUCONATE, CITRUS BIOFLAVONOIDS, SUS SCROFA EYE, AMMONIUM CHLORIDE, CALCIUM FLUORIDE, CAUSTICUM, CONIUM MACULATUM FLOWERING TOP, CYANOCOBALAMIN, GERMANIUM SESQUIOXIDE, MAGNESIUM CARBONATE, SELENIUM DIOXIDE, SILICON DIOXIDE, BETA CAROTENE
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, Taraxacum Officinale 3X, Hydrastis Canadensis 5X, Glutathione 6X, Ubidecarenonum 6X, Zincum Gluconicum 6X, Citrus Bioflavonoids 8X, Eye 8X, Ammonium Muriaticum 12X, Calcarea Fluorica 12X, Causticum 12X, Conium Maculatum 12X, Cyanocobalaminum 12X, Germanium Sesquioxide 12X, Magnesia Carbonica 12X, Selenium Dioxide 12X, Silicea 12X, Beta Carotene 9C.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of minor inflammation, burning & swelling of the eyelids.

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 minor inflammation, burning & swelling of the eyelids.

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 I

HOMEOPATHIC

1 FL OZ (30 ml)

Occuloplex IOcculoplex I

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0600-12024-03-26C16284748780-1f386c64a-3574-0266-e053-dadaa90a7c1aDRUG FACTS:
43857-0600-12023-01-30C16284748780-1f386c64a-3574-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0600-1OcculoplexI30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0600OCCULOPLEX I (EUPHRASIA OFFICINALIS, GINKGO BILOBA, TARAXACUM OFFICINALE, HYDRASTIS CANADENSIS, GLUTATHIONE, UBIDECARENONUM, ZINCUM GLUCONICUM, CITRUS BIOFLAVONOIDS, EYE (SUIS), AMMONIUM MURIATICUM, CALCAREA FLUORICA, CAUSTICUM, CONIUM MACULATUM, CYANOCOBALAMIN, GERMANIUM SESQUIOXIDE, MAGNESIA CARBONICA, SELENIUM DIOXIDE, SILICEA, BETA CAROTENE) LIQUID [BIOACTIVE NUTRITIONAL, INC.]3Current NDC, Legacy NDC, 1 package rows20240509_c2c9b577-4f75-4ddc-815f-46c3bb9b46d2.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-060043857-0600-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
EUPHRASIA STRICTAC9642I91WLACTIB
GINKGO19FUJ2C58TACTIB
TARAXACUM OFFICINALE39981FM375ACTIB
GOLDENSEALZW3Z11D0JVACTIB
GLUTATHIONEGAN16C9B8OACTIB
UBIDECARENONEEJ27X76M46ACTIB
ZINC GLUCONATEU6WSN5SQ1ZACTIB
CITRUS BIOFLAVONOIDSBD70459I50ACTIB
SUS SCROFA EYEX3AOK514E6ACTIB
AMMONIUM CHLORIDE01Q9PC255DACTIM
CALCIUM FLUORIDEO3B55K4YKIACTIB
CAUSTICUMDD5FO1WKFUACTIB
CONIUM MACULATUM FLOWERING TOPQ28R5GF371ACTIB
CYANOCOBALAMINP6YC3EG204ACTIB
GERMANIUM SESQUIOXIDE96WE91N25TACTIB
MAGNESIUM CARBONATE0E53J927NAACTIB
SELENIUM DIOXIDE9N3UK29E57ACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
BETA CAROTENE01YAE03M7JACTIB
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
Occuloplex IEUPHRASIA OFFICINALIS, GINKGO BILOBA, TARAXACUM OFFICINALE, HYDRASTIS CANADENSIS, GLUTATHIONE, UBIDECARENONUM, ZINCUM GLUCONICUM, CITRUS BIOFLAVONOIDS, EYE (SUIS), AMMONIUM MURIATICUM, CALCAREA FLUORICA, CAUSTICUM, CONIUM MACULATUM, CYANOCOBALAMIN, GERMANIUM SESQUIOXIDE, MAGNESIA CARBONICA, SELENIUM DIOXIDE, SILICEA, BETA CAROTENEBioActive Nutritional, Inc.c2c9b577-4f75-4ddc-815f-46c3bb9b46d22024-05-08WarningsExact identifier
ndc (package): 43857-0600-1
ndc (product): 43857-0600
ndc11 (package): 43857060001
spl id: 32c14ba1-b46d-4714-9e7b-06e64c79a8da
spl set id: c2c9b577-4f75-4ddc-815f-46c3bb9b46d2

Reported adverse events (FAERS/openFDA)#

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