Eye Itch

Manufacturer
Meijer Distribution Inc | Akorn Operating Company LLC | Akorn | Akorn AG
Effective date
2022-02-10
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 23:48:12

Label at a glance#

ProductEye Itch
Active ingredientketotifen fumarate
Label structure10 sections

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#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ketotifen (0.025%)

(equivalent to ketotifen fumarate 0.035%)

Purpose

OTC - PURPOSE SECTION

Antihistamine

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

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 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

OTHER SAFETY INFORMATION

  • 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, Water for Injection.

May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH.

OTC - QUESTIONS SECTION

Principal Display Panel Text for Container LabelPrincipal Display Panel Text for Container Label Questions or comments?

1-800-923-5676

Serious side effects associated with use of this product may be reported to this number

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC 41250-302-01

meijer logo®

eye itch relief

Ketotifen Fumarate

Ophthalmic Solution 0.035%

Antihistamine Eye Drops

5 mL (0.17 FL OZ)

Sterile

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 41250-302-01

Compare to Zaditor®

active ingredient*

meijer Logo®

ORIGINAL

PRESCRIPTION

STRENGTH

eye itch

relief

Ketotifen Fumarate

Ophthalmic Solution 0.035%

Antihistamine Eye Drops

Up to 12 Hours of Relief

Works in Minutes

STERILE

30 Day Supply

5 mL (0.17 FL OZ)

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311237ketotifen 0.025 % Ophthalmic SolutionPSN8
311237ketotifen 0.25 MG/ML Ophthalmic SolutionSCD8
311237ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic SolutionSY8
311237ketotifen 0.025 % Ophthalmic SolutionSY8
311237ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic SolutionSY8

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
KETOTIFEN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa9ae9d1-ed96-4d6e-8814-0a4815bc3229Product name120221208

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41250-302-012024-01-30C16284748780-11030e365-46bf-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-302-01Eye Itch1 in 1 CARTONSOLUTION/ DROPS18
41250-302-01Eye Itch5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS58

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-302EYE ITCH (KETOTIFEN FUMARATE) SOLUTION/ DROPS [MEIJER DISTRIBUTION INC ]8Legacy NDC, 2 package rows20220211_fc430abb-a2ed-45e5-832a-d40d1882da11.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ketotifen fumarateACTIVE INGREDIENTHBD503WORO2
KetotifenACTIVE MOIETYX49220T18G2
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W72
glycerinINACTIVE INGREDIENTPDC6A3C0OX2
hydrochloric acidINACTIVE INGREDIENTQTT17582CB2
sodium hydroxideINACTIVE INGREDIENT55X04QC32I2
waterINACTIVE INGREDIENT059QF0KO0R2

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
41250-30241250-302-01

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 ACIDQTT17582CBSOLUTION / INTRAOCULARADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISPRAY, METERED / NASALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ICAPSULE, LIQUID FILLED / ORAL1.5 mgExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IDROPS / OPHTHALMICNAExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / PERINEURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRATHECALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ITABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
174 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IFILM, SOLUBLE / ORAL11 mgExact identifier — unii candidate
174 equally ranked IID candidates
benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / INTRAVENOUS1037 mgExact identifier — unii candidate
148 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / PARENTERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRATHECAL176 mgExact identifier — unii candidate
174 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBPOWDER, FOR SUSPENSION / ENDOTRACHEALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBSUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS5 mgExact identifier — unii candidate
148 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBINJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUSADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBSOLUTION / INTRAVASCULARADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IGEL, METERED / TRANSDERMAL350 mgExact identifier — unii candidate
174 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRAPLEURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBCONCENTRATE / ORAL2.17 mg/1mlExact identifier — unii candidate
148 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IMOUTHWASH / BUCCAL2 mg/1mlExact identifier — unii candidate
174 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBINJECTION, SUSPENSION / INTRAMUSCULARADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, EMULSION / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAVASCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRAPERITONEALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
benzalkonium chlorideBENZALKONIUM CHLORIDEF5UM2KM3W7CLOTH / TOPICALNAExact identifier — unii candidate
24 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IFILM, SOLUBLE / BUCCAL5 mgExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / SUBCONJUNCTIVALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUSADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBGEL / OPHTHALMICADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ITABLET, FILM COATED / ORAL8 mgExact identifier — unii candidate
174 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBSPRAY, METERED / RESPIRATORY (INHALATION)ADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBINJECTION, SUSPENSION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / SUBMUCOSALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS4.17 mgExact identifier — unii candidate
148 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IAEROSOL, FOAM / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IEMULSION / TOPICAL0.2 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ITABLET, DELAYED RELEASE / ORAL4 mgExact identifier — unii candidate
174 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBSOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
hydrochloric acidHYDROCHLORIC ACIDQTT17582CBSOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / SOFT TISSUEADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRACARDIACADJ PHExact identifier — unii candidate
174 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
6374efa7-a338-4672-a6ef-c8e94d2ae240fc430abb-a2ed-45e5-832a-d40d1882da112022-02-10WarningsExact identifier
spl id: 6374efa7-a338-4672-a6ef-c8e94d2ae240
spl set id: fc430abb-a2ed-45e5-832a-d40d1882da11

Reported adverse events (FAERS/openFDA)#

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