FDA.reportPublic FDA data

Allergy Eye Relief

Manufacturer
Similasan Corporation
Effective date
2020-07-10
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 02:13:15

Label at a glance#

ProductAllergy Eye Relief
Active ingredientAPIS MELLIFERA, EUPHRASIA STRICTA, SCHOENOCAULON OFFICINALE SEED
Label structure17 sections

Indications and uses

According to homeopathic principles, the active ingredients in this product temporarily relieve minor eye allergy symptoms such as: itching       burning excessive watering redness of eyes and lids

Dosage and administration

For adults and children age 2 and over: twist flat end with ball to open squeeze plastic dropper to release 2-3 drops into eye and discard applicator apply as needed

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Apis mellifica 6X

Purpose

OTC - PURPOSE SECTION

burning, itching, stinging

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Euphrasia officinalis (Eyebright) 6X

Purpose

OTC - PURPOSE SECTION

redness, swelling, watering

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sabadilla 6X

Purpose

OTC - PURPOSE SECTION

watering, redness of lids

Uses*:

INDICATIONS & USAGE SECTION

According to homeopathic principles, the active ingredients in this product temporarily relieve minor eye allergy symptoms such as:

  • itching      
  • burning
  • excessive watering
  • redness of eyes and lids

Warnings:

WARNINGS SECTION

  • For external use only.
  • According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).
  • Use only if single-use dropper is intact.
  • To avoid contamination, do not touch the tip of the dropper to any surface. Do not reuse. Once opened, discard.
  • Contact wearers: consult a physician prior to using.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Do not use:

OTC - DO NOT USE SECTION

  • if the solution changes color or becomes cloudy

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • symptoms worsen or persist for more than 72 hours
  • you experience eye pain or changes in vision

Directions:

DOSAGE & ADMINISTRATION SECTION

For adults and children age 2 and over:

  • twist flat end with ball to open
  • squeeze plastic dropper to release 2-3 drops into eye and discard applicator
  • apply as needed

Other Information:

OTHER SAFETY INFORMATION

Active ingredients are manufactured according to homeopathic principles.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Phosphate buffer, Purified water

Questions?

OTC - QUESTIONS SECTION

Reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com.

www.SimilasanUSA.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 59262-354-13

Similasan

Allergy Eye Relief

STERILE EYE DROPS

10 ml / 0.33 fl oz

NDC 59262-354-13 Similasan Allergy Eye Relief STERILE EYE DROPS 10 ml / 0.33 fl ozNDC 59262-354-13 Similasan Allergy Eye Relief STERILE EYE DROPS 10 ml / 0.33 fl oz

Similasan Allergy Eye Relief STERILE EYE DROPSSimilasan Allergy Eye Relief STERILE EYE DROPS

Similasan Allergy Eye Relief colirio esteril Spanish LabelSimilasan Allergy Eye Relief colirio esteril Spanish Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59262-354-012023-01-30C16284748780-1f386c64a-13a5-0266-e053-dadaa90a7c1aAllergy Eye Relief Trial Size
59262-354-132023-01-30C16284748780-1f386c64a-13a5-0266-e053-dadaa90a7c1aAllergy Eye Relief Trial Size

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59262-354-01Allergy Eye Relief0.4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.47
59262-354-01Allergy Eye Relief200 in 1 CARTONSOLUTION/ DROPS2007
59262-354-13Allergy Eye Relief.4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS.47

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59262-354ALLERGY EYE RELIEF (APIS AND EUPHRASIA AND SABADILLA) SOLUTION/ DROPS [SIMILASAN CORPORATION]7Legacy NDC, 3 package rows20200709_3f0ddebd-7d36-43cb-ba40-45998546a7a7.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
APIS MELLIFERAACTIVE INGREDIENT7S82P3R43Z4
EUPHRASIA STRICTAACTIVE INGREDIENTC9642I91WL4
SCHOENOCAULON OFFICINALE SEEDACTIVE INGREDIENT6NAF1689IO4
APIS MELLIFERAACTIVE MOIETY7S82P3R43Z4
EUPHRASIA STRICTAACTIVE MOIETYC9642I91WL4
SCHOENOCAULON OFFICINALE SEEDACTIVE MOIETY6NAF1689IO4
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6F4
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEINACTIVE INGREDIENT5QWK6659564
WATERINACTIVE INGREDIENT059QF0KO0R4

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59262-35459262-354-01, 59262-354-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
APIS MELLIFERA7S82P3R43ZACTIB
EUPHRASIA STRICTAC9642I91WLACTIB
SCHOENOCAULON OFFICINALE SEED6NAF1689IOACTIB
WATER059QF0KO0RIACT
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT

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 2 · 61 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FTROCHE / ORAL28 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATESODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956INJECTION / INTRAVENOUS12.8 mgExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SUSPENSION / INTRASYNOVIAL3 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATESODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956SUSPENSION / ORAL140 mgExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FCAPSULE / ORAL40 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION / INTRA-ARTICULAR28 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSOLUTION / INTRAVENOUS381 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSOLUTION / NASAL5 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION / INTRAVENOUS381 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSUSPENSION / OPHTHALMICNAExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATESODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956INJECTION / SUBCUTANEOUS0.3 %w/vExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FFILM, SOLUBLE / ORAL0.05 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SUSPENSION / SOFT TISSUE3 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS139.2 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FTABLET, FILM COATED / ORAL0.01 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSYRUP / ORAL70 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SOLUTION / SUBCUTANEOUS0.11 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION / SUBCUTANEOUS20 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATESODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956SOLUTION / OPHTHALMIC2 mgExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSUSPENSION / ORAL66 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATESODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956GEL / TOPICAL0.02 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FFILM / SUBLINGUAL6 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATESODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956SOLUTION / ORAL63 mgExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SOLUTION / INTRATHECAL1 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATESODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956INJECTION / INTRAMUSCULAR12.8 mgExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SOLUTION / INTRAVESICAL38.25 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FCREAM / TOPICAL0.36 %w/wExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION / INTRAMUSCULAR1751 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSPRAY, METERED / NASAL7 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION / INTRALESIONAL28 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FAEROSOL, FOAM / TOPICAL0.09 %w/wExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, EMULSION / INTRAVENOUS0.28 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FLOZENGE / TRANSMUCOSAL112 mgExact identifier — unii candidate
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SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSOLUTION/ DROPS / OPHTHALMIC1.4 %w/vExact identifier — unii candidate
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SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINSERT / INTRAOCULAR0.02 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SUSPENSION / INTRA-ARTICULAR36 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FLIQUID / INTRAVENOUS381 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSPRAY / NASAL1 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATESODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS1.6 mgExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FTABLET, EXTENDED RELEASE / ORAL210 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATESODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956INJECTION, SOLUTION / SUBCUTANEOUS0.3 %w/vExact identifier — unii candidate
13 equally ranked IID candidates
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48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATESODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956INJECTION, SOLUTION / INTRAVENOUS115 mgExact identifier — unii candidate
13 equally ranked IID candidates
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48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSOLUTION / ORAL140 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SUSPENSION / INTRALESIONAL3 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FTABLET, FOR SUSPENSION / ORAL60 mgExact identifier — unii candidate
48 equally ranked IID candidates
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48 equally ranked IID candidates
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48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SOLUTION / INTRAVENOUS2460 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR139.2 mgExact identifier — unii candidate
48 equally ranked IID candidates
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48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SUSPENSION / INTRAMUSCULAR36 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATESODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956INJECTION, SOLUTION / INTRATHECAL0.01 %w/vExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FCAPSULE, DELAYED RELEASE / ORAL43 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSOLUTION/ DROPS / TOPICAL0.14 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATESODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956SOLUTION/ DROPS / OPHTHALMIC1.15 %w/vExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR1751 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FTABLET / ORAL96 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATESODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS1.3 mgExact identifier — unii candidate
13 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
4fb82880-2d17-48ad-aa2d-cdbacdff73483f0ddebd-7d36-43cb-ba40-45998546a7a72020-07-10WarningsExact identifier
spl id: 4fb82880-2d17-48ad-aa2d-cdbacdff7348
spl set id: 3f0ddebd-7d36-43cb-ba40-45998546a7a7

Reported adverse events (FAERS/openFDA)#

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