ALOCRIL

Product NDC: 0023-8842
11-digit product format: 000238842
Labeler code: 0023
Product ID: 0023-8842_0aeb87da-f1d5-4a28-ad87-80fb3c31b3ea
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nedocromil sodium
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Allergan, Inc.
Application: NDA021009
Marketing category: NDA
Marketing start: 2000-02-03
Marketing end: 0000-00-00
Substance: NEDOCROMIL SODIUM
Active strength: 20 mg/mL
Pharmacologic classes: Decreased Histamine Release [PE], Mast Cell Stabilizer [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0023-8842		D	Discontinued by firm		2026-10-05
excluded package	package	0023-8842	0023-8842-05	D	Discontinued by firm		2026-10-05

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
N021009-001	ALOCRIL	NEDOCROMIL SODIUM	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1999-12-08

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 · 43 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
2026-09-14 22:38:34	2026-08	N021009-001	ALOCRIL	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1999-12-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021009-001	ALOCRIL	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1999-12-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021009-001	ALOCRIL	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1999-12-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021009-001	ALOCRIL	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1999-12-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021009-001	ALOCRIL	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1999-12-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021009-001	ALOCRIL	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1999-12-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021009-001	ALOCRIL	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1999-12-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021009-001	ALOCRIL	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1999-12-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021009-001	ALOCRIL	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1999-12-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021009-001	ALOCRIL	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1999-12-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021009-001	ALOCRIL	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1999-12-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021009-001	ALOCRIL	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1999-12-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021009-001	ALOCRIL	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1999-12-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021009-001	ALOCRIL	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1999-12-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021009-001	ALOCRIL	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1999-12-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021009-001	ALOCRIL	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD	1999-12-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021009-001	ALOCRIL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1999-12-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021009-001	ALOCRIL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1999-12-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021009-001	ALOCRIL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1999-12-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021009-001	ALOCRIL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1999-12-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021009-001	ALOCRIL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1999-12-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021009-001	ALOCRIL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1999-12-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021009-001	ALOCRIL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1999-12-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021009-001	ALOCRIL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1999-12-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021009-001	ALOCRIL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1999-12-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021009-001	ALOCRIL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1999-12-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021009-001	ALOCRIL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1999-12-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021009-001	ALOCRIL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1999-12-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021009-001	ALOCRIL	2%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1999-12-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021009-001	ALOCRIL	2%	SOLUTION/DROPS / OPHTHALMIC		RLD	1999-12-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021009-001	ALOCRIL	2%	SOLUTION/DROPS / OPHTHALMIC		RLD	1999-12-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021009-001	ALOCRIL	2%	SOLUTION/DROPS / OPHTHALMIC		RLD	1999-12-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021009-001	ALOCRIL	2%	SOLUTION/DROPS / OPHTHALMIC		RLD	1999-12-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021009-001	ALOCRIL	2%	SOLUTION/DROPS / OPHTHALMIC		RLD	1999-12-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021009-001	ALOCRIL	2%	SOLUTION/DROPS / OPHTHALMIC		RLD	1999-12-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021009-001	ALOCRIL	2%	SOLUTION/DROPS / OPHTHALMIC		RLD	1999-12-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021009-001	ALOCRIL	2%	SOLUTION/DROPS / OPHTHALMIC		RLD	1999-12-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021009-001	ALOCRIL	2%	SOLUTION/DROPS / OPHTHALMIC		RLD	1999-12-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021009-001	ALOCRIL	2%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1999-12-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021009-001	ALOCRIL	2%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1999-12-08	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021009-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021009-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021009-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021009-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021009-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021009-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021009-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021009-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021009-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021009-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021009-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021009-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021009-001	AT	1	`ea99ee380514…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021009-001	AT	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0023-8842-05	ML - Milliliter	0023-8842	dc21b2c7-93ab-4b5a-b8cc-7bf50cc020e0	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
nedocromil sodium	ACTIVE INGREDIENT	ET8IF4KS1T	ALOCRIL (NEDOCROMIL SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]	5
nedocromil	ACTIVE MOIETY	0B535E0BN0	ALOCRIL (NEDOCROMIL SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]	5
benzalkonium chloride	INACTIVE INGREDIENT	F5UM2KM3W7	ALOCRIL (NEDOCROMIL SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]	5
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	ALOCRIL (NEDOCROMIL SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]	5
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	ALOCRIL (NEDOCROMIL SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]	5
water	INACTIVE INGREDIENT	059QF0KO0R	ALOCRIL (NEDOCROMIL SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0023-8842	ALOCRIL (NEDOCROMIL SODIUM) SOLUTION/ DROPS [ALLERGAN, INC.]	11	Legacy NDC	20240913_2fe8d7ad-2158-4169-94b0-719ad20242b7.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ET8IF4KS1T	NEDOCROMIL SODIUM	69049-74-7	NEDOCROMIL SODIUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0023-8842-05	00023884205	1 BOTTLE, DROPPER in 1 CARTON (0023-8842-05) > 5 mL in 1 BOTTLE, DROPPER	2000-02-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ALOCRIL ® (nedocromil sodium ophthalmic solution) 2% sterile	Allergan, Inc.	2018-06-01	HUMAN PRESCRIPTION DRUG LABEL	11