Alcaftadine Ophthalmic Solution 0.25%

Manufacturer: Gland Pharma Limited
Effective date: 2024-03-05
Label type: Human OTC Drug Label
Version: 3
Source: full-release
Hydrated at: 2026-06-01 00:09:27

Label at a glance#

ProductAlcaftadine

Active ingredientALCAFTADINE

Label structure13 sections

Dosage and administration

adults and children 2 years of age and older: put 1 drop in the affected eye(s) once daily if using other ophthalmic products while using this product, wait at least 5 minutes between each product replace cap after each use children under 2 years of age: consult a doctor

Contacts and useful links#

PhoneLabel contact866-770-7144

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcaftadine 0.25%

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
■ do not wear a contact lens if your eye is red

Stop use and ask a doctor if

OTC - STOP USE SECTION

you experience any of the following:
■ eye pain
■ changes in vision
■ increased redness of the eye
■ itching that worsens or lasts for 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 2 years of age and older:
- put 1 drop in the affected eye(s) once daily
- if using other ophthalmic products while using this product, wait at least 5 minutes between each product
- replace cap after each use
children under 2 years of age: consult a doctor

Other information

SPL UNCLASSIFIED SECTION

only for use in the eye
store at 15° to 25°C (59° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride 0.005%, edetate disodium, monobasic sodium phosphate, sodium chloride, sodium hydroxide and/or hydrochloric acid, water for injection

Questions or comments?

SPL UNCLASSIFIED SECTION

866-770-7144

(Monday – Friday 9:00 AM to 6:00 PM EST)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container Label - 0.25% (3 mL)

NDC-68083-649-01
Alcaftadine
Ophthalmic Solution
0.25%
Antihistamine Eye Drops
0.10 fl oz (3 mL) Sterile

alcaftadine-spl-container-label

Container Carton - 0.25% (3 mL)

ORIGINAL PRESCRIPTION STRENGTH
NDC-68083-649-01 3 mL
Alcaftadine
Ophthalmic Solution
0.25%
Antihistamine Eye Drops
ONCE DAILY RELIEF
Eye Allergy Itch Relief

Works in Minutes
Relief from Allergens:
• Pet Dander • Pollen
• Grass • Ragweed

40 DAY SUPPLY

Sterile 0.10 fl oz (3 mL)

Container Carton - 0.25% (3 mL) - Twin Pack

ORIGINAL PRESCRIPTION STRENGTH

TWIN PACK
NDC-68083-649-02 3 mL
Alcaftadine
Ophthalmic Solution
0.25%
Antihistamine Eye Drops
ONCE DAILY RELIEF
Eye Allergy Itch Relief

Works in Minutes
Relief from Allergens:
• Pet Dander • Pollen
• Grass • Ragweed

80 DAY SUPPLY

Sterile Two 3 mL bottles (0.10 fl oz each)

alcaftadine-spl-carton-label-twin-pack

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1000085	alcaftadine 0.25 % Ophthalmic Solution	PSN	3
1000085	alcaftadine 2.5 MG/ML Ophthalmic Solution	SCD	3
1000085	alcaftadine 0.25 % Ophthalmic Solution	SY	3

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
ALCAFTADINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4b7a6bd5-956e-f134-86e5-d4d9706c15d4	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68083-649-01	Alcaftadine	1 in 1 CARTON	SOLUTION/ DROPS	1	3
68083-649-01	Alcaftadine	3 mL in 1 BOTTLE	SOLUTION/ DROPS	3	3
68083-649-02	Alcaftadine	2 in 1 CARTON	SOLUTION/ DROPS	2	3
68083-649-02	Alcaftadine	3 mL in 1 BOTTLE	SOLUTION/ DROPS	3	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68083-649	ALCAFTADINE SOLUTION/ DROPS [GLAND PHARMA LIMITED]	3	Current NDC, 4 package rows	20240307_b94e071d-421d-48ec-a4ea-254aa8af19ff.zip

Products#

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

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

Alcaftadine
BENZALKONIUM CHLORIDE
EDETATE DISODIUM
HYDROCHLORIC ACID
SODIUM PHOSPHATE, MONOBASIC
SODIUM CHLORIDE
SODIUM HYDROXIDE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68083-649	68083-649-01, 68083-649-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALCAFTADINE	7Z8O94ECSX	ACTIB
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
HYDROCHLORIC ACID	QTT17582CB	IACT
SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209706-001	ALCAFTADINE	ALCAFTADINE	0.25%	SOLUTION/DROPS / OPHTHALMIC			2024-03-01

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A209706-001	ALCAFTADINE	0.25%	SOLUTION/DROPS / OPHTHALMIC	2024-03-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209706-001	ALCAFTADINE	0.25%	SOLUTION/DROPS / OPHTHALMIC	2024-03-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209706-001	ALCAFTADINE	0.25%	SOLUTION/DROPS / OPHTHALMIC	2024-03-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209706-001	ALCAFTADINE	0.25%	SOLUTION/DROPS / OPHTHALMIC	2024-03-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209706-001	ALCAFTADINE	0.25%	SOLUTION/DROPS / OPHTHALMIC	2024-03-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209706-001	ALCAFTADINE	0.25%	SOLUTION/DROPS / OPHTHALMIC	2024-03-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209706-001	ALCAFTADINE	0.25%	SOLUTION/DROPS / OPHTHALMIC	2024-03-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209706-001	ALCAFTADINE	0.25%	SOLUTION/DROPS / OPHTHALMIC	2024-03-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209706-001	ALCAFTADINE	0.25%	SOLUTION/DROPS / OPHTHALMIC	2024-03-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209706-001	ALCAFTADINE	0.25%	SOLUTION/DROPS / OPHTHALMIC	2024-03-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209706-001	ALCAFTADINE	0.25%	SOLUTION/DROPS / OPHTHALMIC	2024-03-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209706-001	ALCAFTADINE	0.25%	SOLUTION/DROPS / OPHTHALMIC	2024-03-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209706-001	ALCAFTADINE	0.25%	SOLUTION/DROPS / OPHTHALMIC	2024-03-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209706-001	ALCAFTADINE	0.25%	SOLUTION/DROPS / OPHTHALMIC	2024-03-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209706-001	ALCAFTADINE	0.25%	SOLUTION/DROPS / OPHTHALMIC	2024-03-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209706-001	ALCAFTADINE	0.25%	SOLUTION/DROPS / OPHTHALMIC	2024-03-01	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209706-001	ALCAFTADINE	0.25%	SOLUTION/DROPS / OPHTHALMIC	2024-03-01	`6a51e52b5d6a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209706-001	ALCAFTADINE	0.25%	SOLUTION/DROPS / OPHTHALMIC	2024-03-01	`a50c72e98297…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alcaftadine	ALCAFTADINE	Gland Pharma Limited	b94e071d-421d-48ec-a4ea-254aa8af19ff	2024-03-05	Warnings	Exact identifier ndc (package): 68083-649-02 ndc (package): 68083-649-01 ndc (product): 68083-649 ndc11 (package): 68083064901 ndc11 (package): 68083064902 spl id: 8c937f90-5ae8-49e9-808d-f3dbd9da1882 spl set id: b94e071d-421d-48ec-a4ea-254aa8af19ff

Reported adverse events (FAERS/openFDA)#

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