OpenRx Open Medications Explorer
© 2026 OpenRx · public-domain U.S. government data
On this page

Alcaftadine

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Alcaftadine
Generic name
Alcaftadine
Dosage form
Solution/ Drops
Route
Ophthalmic
Marketing category
ANDA · ANDA
Labeler
Alembic Pharmaceuticals Inc.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
3
Packages
5
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Alcaftadine 2.5 mg/mL 1000085 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Solution/ Drops
Route of administration
Ophthalmic
Presentations
8

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Histamine H1 Receptor Antagonists [MoA] MoA All 136 members
Histamine-1 Receptor Antagonist [EPC] EPC All 134 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
209290
Application type
ANDA · Abbreviated New Drug Application
Approval date
October 2, 2024
Sponsor
ALEMBIC
Products on application
1
Submissions recorded
1
Products approved under application 209290.
Product Trade name Form Strength Ingredient Status TE Flags
209290-001 ALCAFTADINE SOLUTION/DROPS ALCAFTADINE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 209290.
Type No. Action Status Date Review
Original application 1 Approved October 2, 2024 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20240305). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20240305 HUMAN OTC DRUG · 20230623

Indications and Usage

openFDA Drug Labeling

Use temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander

Purpose

openFDA Drug Labeling

Purpose Antihistamine

Dosage and Administration

openFDA Drug Labeling

Directions 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

Warnings

openFDA Drug Labeling

Warnings For external use only

Do Not Use

openFDA Drug Labeling

Do not use ■ if solution changes color or becomes cloudy ■ if you are sensitive to any ingredient in this product ■ to treat contact lens related irritation

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if 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

Active Ingredient

openFDA Drug Labeling

Drug Facts Active ingredient Alcaftadine 0.25%

Adverse event reports

Source: openFDA FAERS
902
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: ALCAFTADINE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
62332-147-03 62332-147 Alembic Pharmaceuticals Inc. 1 BOTTLE in 1 CARTON (62332-147-03) / 3 mL in 1 BOTTLE October 2, 2024
58602-605-40 58602-605 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-605-40) / 5 mL in 1 BOTTLE June 23, 2023
58602-605-42 58602-605 Aurohealth LLC 2 BOTTLE in 1 CARTON (58602-605-42) / 5 mL in 1 BOTTLE June 23, 2023
68083-649-01 68083-649 Gland Pharma Limited 1 BOTTLE in 1 CARTON (68083-649-01) / 3 mL in 1 BOTTLE March 1, 2024
68083-649-02 68083-649 Gland Pharma Limited 2 BOTTLE in 1 CARTON (68083-649-02) / 3 mL in 1 BOTTLE March 1, 2024
62332-147 62332-147 Alembic Pharmaceuticals Inc. — October 2, 2024
58602-605 58602-605 Aurohealth LLC — June 23, 2023
68083-649 68083-649 Gland Pharma Limited — March 1, 2024

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.