Home NDC 11822-5533 Eye Itch Releif
Product NDC 11822-5533
11-digit product format 118225533
Labeler code 11822
Product ID 11822-5533_1ddd5a87-3863-532b-e063-6394a90ab8bf
Type HUMAN OTC DRUG
Nonproprietary name Ketotifen Fumarate
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Rite Aid Corporation
Application NDA021996
Marketing category NDA
Marketing start 2022-04-01
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 2026-12-31
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.
Product history page 1 of 3 · 82 observed 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 2026-02-19 14:30 UTC 2026-02 N021996-001 ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2006-12-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021996-002 CHILDREN'S ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD 2015-02-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021996-001 ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2006-12-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021996-002 CHILDREN'S ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD 2015-02-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021996-001 ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2006-12-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021996-002 CHILDREN'S ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD 2015-02-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021996-001 ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2006-12-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021996-002 CHILDREN'S ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD 2015-02-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021996-001 ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2006-12-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021996-002 CHILDREN'S ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD 2015-02-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021996-001 ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2006-12-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021996-002 CHILDREN'S ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD 2015-02-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021996-001 ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2006-12-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021996-002 CHILDREN'S ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD 2015-02-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021996-001 ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2006-12-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021996-002 CHILDREN'S ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD 2015-02-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021996-001 ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2006-12-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021996-002 CHILDREN'S ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD 2015-02-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021996-001 ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2006-12-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021996-002 CHILDREN'S ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD 2015-02-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021996-001 ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2006-12-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021996-002 CHILDREN'S ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD 2015-02-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021996-001 ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2006-12-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021996-002 CHILDREN'S ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD 2015-02-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021996-001 ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2006-12-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021996-002 CHILDREN'S ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD 2015-02-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021996-001 ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2006-12-01 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021996-002 CHILDREN'S ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD 2015-02-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021996-001 ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2006-12-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021996-002 CHILDREN'S ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD 2015-02-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021996-001 ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2006-12-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021996-002 CHILDREN'S ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD 2015-02-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021996-001 ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2006-12-01 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021996-002 ALAWAY EQ 0.035% BASE SOLUTION/DROPS / OPHTHALMIC RLD 2015-02-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021996-001 ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2006-12-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021996-002 ALAWAY EQ 0.035% BASE SOLUTION/DROPS / OPHTHALMIC RLD 2015-02-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021996-001 ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2006-12-01 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021996-002 ALAWAY EQ 0.035% BASE SOLUTION/DROPS / OPHTHALMIC RLD 2015-02-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021996-001 ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2006-12-01 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021996-002 ALAWAY EQ 0.035% BASE SOLUTION/DROPS / OPHTHALMIC RLD 2015-02-11 782e0a99824c…
Additional Listing Data#
Finished product Yes
Brand name base Eye Itch Releif
Listing expiration 2026-12-31 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 11822-5533-1 Eye Itch Releif 10 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 10 3 11822-5533-1 Eye Itch Releif 1 in 1 CARTON SOLUTION/ DROPS 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11822-5533 EYE ITCH RELEIF (KETOTIFEN FUMARATE) SOLUTION/ DROPS [RITE AID CORPORATION] 3 Current NDC, Legacy NDC, 2 package rows 20240724_6a7be1e9-27ff-44d8-85ed-fc1b0017180e.zip
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 · 15 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 11822-5533-1 11822553301 1 BOTTLE, DROPPER in 1 CARTON (11822-5533-1) / 10 mL in 1 BOTTLE, DROPPER 2022-04-01 0000-00-00 No No Current