Home NDC 50804-601-05 Eye Itch Relief
Product NDC 50804-601
Requested package NDC 50804-601-05
11-digit product format 508040601
Labeler code 50804
Product ID 50804-601_48728697-b0d0-e765-e063-6294a90a6041
Type HUMAN OTC DRUG
Nonproprietary name Ketotifen Fumarate
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler PERRIGO DIRECT INC.
Application NDA021996
Marketing category NDA
Marketing start 2024-04-01
Substance KETOTIFEN FUMARATE
Active strength .25 mg/mL
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021996-001 ALAWAY KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2006-12-01 N021996-002 CHILDREN'S ALAWAY KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD 2015-02-11
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 Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N021996-001 ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2006-12-01 a50c72e98297…2026-08-01 22:54:32 2026-06 N021996-002 CHILDREN'S ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD 2015-02-11 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 15 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Eye Itch Relief
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength KETOTIFEN FUMARATE .25 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination HBD503WORO Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311237 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50804-601-05 Eye Itch Relief 1 in 1 CARTON SOLUTION/ DROPS 1 3 50804-601-05 Eye Itch Relief 5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 5 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50804-601 EYE ITCH RELIEF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [PERRIGO DIRECT INC.] 2 Current NDC, 2 package rows 20240410_d3049296-0d15-4523-883c-25f8817bc735.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 50804-601-05 50804060105 1 BOTTLE, DROPPER in 1 CARTON (50804-601-05) / 5 mL in 1 BOTTLE, DROPPER 2024-04-01 No No Current