Eye Itch Relief

Manufacturer
H E B | Akorn Operating Company LLC | Akorn
Effective date
2022-01-25
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:47:33

Label at a glance#

ProductEye Itch Relief
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 more than 72 hours

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.

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:

H ■ E ■ B Logo®

NDC 37808-802-01

Eye Itch

Relief

Ketotifen Fumarate

Ophthalmic Solution

Antihistamine Eye Drops

STERILE 5 mL (0.17 FL OZ)

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 37808-802-01 Compare to

the active

ingredients

in Zaditor®*

H ■ E ■ B Logo®

Eye Itch

Relief

Ketotifen Fumarate

Ophthalmic Solution

Antihistamine Eye Drops

Eye Drops

• Works in

Minutes

• Original

Prescription

Strength

• For ages

3 years

& Older

UP TO

12

HOURS

ITCH RELIEF

STERILE 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 SolutionPSN4
311237ketotifen 0.25 MG/ML Ophthalmic SolutionSCD4
311237ketotifen 0.025 % (as ketotifen fumarate 0.035 % ) Ophthalmic SolutionSY4
311237ketotifen 0.025 % Ophthalmic SolutionSY4
311237ketotifen 0.25 MG/ML (as ketotifen fumarate 0.35 MG/ML) Ophthalmic SolutionSY4

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
37808-802-012024-01-30C16284748780-11030e364-fad9-111a-e063-dadaa90a10e2371c1604-f58d-4be6-b822-89211c9e74c8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-802-01Eye Itch Relief5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS54
37808-802-01Eye Itch Relief1 in 1 CARTONSOLUTION/ DROPS14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-802EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [H E B]4Legacy NDC, 2 package rows20220126_371c1604-f58d-4be6-b822-89211c9e74c8.zip

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
37808-80237808-802-01

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
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / RETROBULBARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBPOWDER / INTRAVENOUSADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IMOUTHWASH / BUCCAL2 mg/1mlExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ILIQUID / INTRAMUSCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRA-ARTERIAL840 mgExact identifier — unii candidate
148 equally ranked IID candidates
Benzalkonium ChlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION/ DROPS / OPHTHALMIC0.02 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
Benzalkonium ChlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SPRAY / NASAL1 mgExact identifier — unii candidate
24 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IPOWDER, FOR SUSPENSION / ENDOTRACHEALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRA-AMNIOTICADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IELIXIR / ORALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBLOTION / TOPICALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / INTRAVITREALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / DENTALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / EXTRACORPOREALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARYADJ 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 HYDROXIDE55X04QC32ISHAMPOO / TOPICAL3 mgExact identifier — unii candidate
174 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBSOLUTION / INTRATHECALADJ 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 HYDROXIDE55X04QC32IINJECTION / SOFT TISSUEADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBSUSPENSION/ DROPS / AURICULAR (OTIC)ADJ 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 ACIDQTT17582CBINJECTION / EPIDURALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
Benzalkonium ChlorideBENZALKONIUM CHLORIDEF5UM2KM3W7CLOTH / TOPICALNAExact identifier — unii candidate
24 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IGEL / OPHTHALMIC6 mgExact identifier — unii candidate
174 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULARADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IAEROSOL, FOAM / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION / PERIDURALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Benzalkonium ChlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / TOPICAL0.01 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IPOWDER, FOR SUSPENSION / ORAL9 mgExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IPASTE / DENTAL0.6 %w/wExact 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 ACIDQTT17582CBCAPSULE, LIQUID FILLED / ORALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ILIQUID / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBSUSPENSION / ORAL100 mgExact identifier — unii candidate
148 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ICAPSULE, DELAYED RELEASE / ORAL0.25 mgExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IEMULSION / ORALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBSOLUTION / INTRAPERITONEALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ITABLET / ORAL10 mgExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / PERIDURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / EPIDURALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
Hydrochloric AcidHYDROCHLORIC ACIDQTT17582CBSOLUTION / INTRAVASCULARADJ 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 44.

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26c2088c7a36db…
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…

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
fd489d14-ac75-415d-9a72-0eeb73e1e58e371c1604-f58d-4be6-b822-89211c9e74c82022-01-25WarningsExact identifier
spl id: fd489d14-ac75-415d-9a72-0eeb73e1e58e
spl set id: 371c1604-f58d-4be6-b822-89211c9e74c8

Reported adverse events (FAERS/openFDA)#

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