Occuloplex

Product NDC
43857-0600
11-digit product format
438570600
Labeler code
43857
Product ID
43857-0600_32c14ba1-b46d-4714-9e7b-06e64c79a8da
Type
HUMAN OTC DRUG
Nonproprietary name
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
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-06-15
Substance
EUPHRASIA 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
Active strength
3; 3; 3; 5; 6; 6; 6; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 9 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Vitamin B 12 [CS], Vitamin B12 [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct43857-0600IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage43857-060043857-0600-1IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Occuloplex
Brand name suffix
I
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EUPHRASIA STRICTA3 [hp_X]/mL
GINKGO3 [hp_X]/mL
TARAXACUM OFFICINALE3 [hp_X]/mL
GOLDENSEAL5 [hp_X]/mL
GLUTATHIONE6 [hp_X]/mL
UBIDECARENONE6 [hp_X]/mL
ZINC GLUCONATE6 [hp_X]/mL
CITRUS BIOFLAVONOIDS8 [hp_X]/mL
SUS SCROFA EYE8 [hp_X]/mL
AMMONIUM CHLORIDE12 [hp_X]/mL
CALCIUM FLUORIDE12 [hp_X]/mL
CAUSTICUM12 [hp_X]/mL
CONIUM MACULATUM FLOWERING TOP12 [hp_X]/mL
CYANOCOBALAMIN12 [hp_X]/mL
GERMANIUM SESQUIOXIDE12 [hp_X]/mL
MAGNESIUM CARBONATE12 [hp_X]/mL
SELENIUM DIOXIDE12 [hp_X]/mL
SILICON DIOXIDE12 [hp_X]/mL
BETA CAROTENE9 [hp_C]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 19 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C9642I91WLInternal UNII lookup
19FUJ2C58TInternal UNII lookup
39981FM375Internal UNII lookup
ZW3Z11D0JVInternal UNII lookup
GAN16C9B8OInternal UNII lookup
EJ27X76M46Internal UNII lookup
U6WSN5SQ1ZInternal UNII lookup
BD70459I50Internal UNII lookup
X3AOK514E6Internal UNII lookup
01Q9PC255DInternal UNII lookup
O3B55K4YKIInternal UNII lookup
DD5FO1WKFUInternal UNII lookup
Q28R5GF371Internal UNII lookup
P6YC3EG204Internal UNII lookup
96WE91N25TInternal UNII lookup
0E53J927NAInternal UNII lookup
9N3UK29E57Internal UNII lookup
ETJ7Z6XBU4Internal UNII lookup
01YAE03M7JInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c2c9b577-4f75-4ddc-815f-46c3bb9b46d2Available on FDA.report

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

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 (product): 43857-0600

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0600-14385706000130 mL in 1 BOTTLE, DROPPER (43857-0600-1) 30 ml2021-06-150000-00-00NoNoCurrent