Itchy Eye Drops

Manufacturer
Amerisource Bergen | Akorn, Inc. | Akorn, Inc
Effective date
2013-12-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:38:39

Label at a glance#

ProductItchy Eye Drops
Active ingredientketotifen fumarate
Label structure11 sections

Indications and uses

Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

Dosage and administration

Adults and children 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8 to 12 hours, no more than twice per day. Children under 3 years of age: Consult a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ketotifen (0.025%)

(equivalent to ketotifen fumarate 0.035%)

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • if solution changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product
  • to treat contact lens related irritation

When using this product

OTC - WHEN USING SECTION

  • do not touch tip of container to any surface to avoid contamination
  • remove contact lenses before use
  • wait at least 10 minutes before reinserting contact lenses after use
  • replace cap after each use
OTC - STOP USE SECTION

Stop use and ask a doctor if you experience any of the following:

  • eye pain
  • changes in vision
  • redness of the eye
  • itching worsens or lasts for more than 72 hours
OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 3 years of age and older:

    Put 1 drop in the affected eye(s) twice daily, every 8 to 12 hours, no more than twice per day.

  • Children under 3 years of age:

    Consult a doctor.

Other information

SPL UNCLASSIFIED SECTION

  • only for use in the eye
  • store at 20° to 25°C (68° to 77°F)

[see USP Controlled Room Temperature].

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride 0.01%, glycerin, purified water.

May contain hydrochloric acid and/or sodium hydroxide (to adjust pH).

Questions or comments?

OTC - QUESTIONS SECTION

1-800-932-5676

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC 46122-146-64

GOOD NEIGHBOR PHARMACY Logo® Sterile

Itchy Eye Drops

ketotifen fumarate

ophthalmic solution

Antihistamine Eye Drops

0.17 fl oz (5 mL)

Principal Display Panel Text for Container Label
Principal Display Panel Text for Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC 46122-146-64

Compare to Zyrtec®

Itchy Eye Drops

active ingredient*

GOOD NEIGHBOR PHARMACY Logo®

► 30 DAY SUPPLY

Itchy Eye

Drops

ketotifen fumarate

ophthalmic solution

Antihistamine Eye Drops

Up to 12 hours

Allergy itchy eye relief

Works in minutes

Original Prescription Strength

For ages 3 years & older

Sterile

0.17 fl oz

(5 mL)

Principal Display Panel Text for Carton Label
Principal Display Panel Text for Carton Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46122-146-642020-10-21C16284748780-19d75b9d0-008e-f424-e053-dadaa90a57ce4d144a0b-8743-458d-96b1-d3920491401f
46122-146-642020-01-31C16284748780-19d75b9d0-008e-f424-e053-dadaa90a57ce4d144a0b-8743-458d-96b1-d3920491401f

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ketotifen fumarateACTIVE INGREDIENTHBD503WORO1
ketotifenACTIVE MOIETYX49220T18G1
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W71
glycerinINACTIVE INGREDIENTPDC6A3C0OX1
hydrochloric acidINACTIVE INGREDIENTQTT17582CB1
sodium hydroxideINACTIVE INGREDIENT55X04QC32I1
waterINACTIVE INGREDIENT059QF0KO0R1

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
46122-14646122-146-64

Ingredients#

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

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

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 8 · 421 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBSOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / SUBMUCOSALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR0.35 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBSOLUTION / NASAL91.7 mg/100mlExact identifier — unii candidate
148 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRACAUDALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBSOLUTION/ DROPS / TOPICALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRASPINALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBSPRAY / RESPIRATORY (INHALATION)ADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / PARENTERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBINJECTION, SUSPENSION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IOINTMENT / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ILIQUID / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR7.01 mgExact identifier — unii candidate
174 equally ranked IID candidates
benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SPRAY, METERED / NASAL1 mgExact identifier — unii candidate
24 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRADERMALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBAEROSOL, SPRAY / RESPIRATORY (INHALATION)1.5 %w/wExact identifier — unii candidate
148 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRAVASCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBLIQUID / ORAL4.46 mg/1mlExact identifier — unii candidate
148 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBPOWDER, FOR SUSPENSION / ORAL125 mgExact identifier — unii candidate
148 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBINJECTION, POWDER, FOR SOLUTION / INTRATUMORADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS78.36 mgExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / DENTALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / RETROBULBARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBSUSPENSION/ DROPS / OPHTHALMICADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / INTRAVASCULARADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IEMULSION / OPHTHALMIC0.02 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / RECTALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / INTRACAUDALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBTABLET / ORAL2.32 mgExact identifier — unii candidate
148 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / EPIDURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBINJECTION, EMULSION / INTRAMUSCULARADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBOINTMENT / TOPICALNAExact identifier — unii candidate
148 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / IONTOPHORESISADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAMUSCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ICAPSULE, COATED / ORAL0.08 mgExact identifier — unii candidate
174 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBPOWDER, FOR SUSPENSION / ENDOTRACHEALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAVESICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBLIQUID / INTRAVENOUSADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBINJECTION, SUSPENSION / INTRAVITREALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRA-ARTERIAL176 mgExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRASYNOVIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBINJECTION, POWDER, FOR SOLUTION / INTRADERMALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IFILM, SOLUBLE / ORAL11 mgExact identifier — unii candidate
174 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRAPLEURALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ITABLET, COATED / ORALNAExact identifier — unii candidate
174 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBINJECTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBINJECTION, POWDER, FOR SOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBINJECTION / SUBMUCOSALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IENEMA / RECTAL0.44 %v/vExact identifier — unii candidate
174 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBLOTION / TOPICALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077958-001KETOTIFEN FUMARATEKETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-2684e616aacf4f…
2026-08-18 06:07:402026-07A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-263f01610625f2…
2019-09-15 20:21 UTC2019-09A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26f41ea6bd6efb…

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
10e91ddb-4d81-4286-a65c-e7756a7fdb594d144a0b-8743-458d-96b1-d3920491401f2020-10-21WarningsExact identifier
spl set id: 4d144a0b-8743-458d-96b1-d3920491401f

Reported adverse events (FAERS/openFDA)#

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