Eye Allergy Relief

Product NDC: 11822-0552
Requested package NDC: 11822-0552-1
11-digit product format: 118220552
Labeler code: 11822
Product ID: 11822-0552_40ee79dc-d62a-4926-aa60-26130a694c30
Type: HUMAN OTC DRUG
Nonproprietary name: Pheniramine Maleate and Naphazoline Hydrochloride
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Rite Aid Corporation
Application: NDA020065
Marketing category: NDA
Marketing start: 2015-07-01
Marketing end: 0000-00-00
Substance: NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE
Active strength: 0 mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	11822-0552	11822-0552-1	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
N020065-001	OPCON-A	NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1994-06-08

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020065-001	OPCON-A	0.02675%;0.315%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1994-06-08	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e18001c8-33ae-5f66-9cdc-a39724bd4573	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
11822-0552-1	2021-06-09	Drug Facts
11822-0552-2	2021-06-09	Drug Facts
11822-0552-1	2021-01-29	Drug Facts
11822-0552-2	2021-01-29	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11822-0552-1	Eye Allergy Relief	1 in 1 CARTON	SOLUTION/ DROPS	1	5
11822-0552-1	Eye Allergy Relief	15 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	15	5
11822-0552-2	Eye Allergy Relief	15 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	15	5
11822-0552-2	Eye Allergy Relief	2 in 1 CARTON	SOLUTION/ DROPS	2	5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NAPHAZOLINE HYDROCHLORIDE	ACTIVE INGREDIENT	MZ1131787D	EYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [RITE AID CORPORATION]	1
PHENIRAMINE MALEATE	ACTIVE INGREDIENT	NYW905655B	EYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [RITE AID CORPORATION]	1
NAPHAZOLINE	ACTIVE MOIETY	H231GF11BV	EYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [RITE AID CORPORATION]	1
PHENIRAMINE	ACTIVE MOIETY	134FM9ZZ6M	EYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [RITE AID CORPORATION]	1
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	EYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [RITE AID CORPORATION]	1
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	EYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [RITE AID CORPORATION]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	EYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [RITE AID CORPORATION]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	EYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [RITE AID CORPORATION]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	EYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [RITE AID CORPORATION]	1
SODIUM BORATE	INACTIVE INGREDIENT	91MBZ8H3QO	EYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [RITE AID CORPORATION]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	EYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [RITE AID CORPORATION]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	EYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [RITE AID CORPORATION]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11822-0552	EYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [RITE AID CORPORATION]	5	Legacy NDC, 4 package rows	20240724_6043040e-3206-40dd-aa87-940b1a84a496.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Opcon-A	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	Bausch & Lomb Incorporated	2d7cfae7-8af4-4fee-93e1-e5cfe455c5a5	2026-03-20	Warnings	Exact identifier application applno (NDA): 020065 application number: NDA020065
EYE ALLERGY RELIEF	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	CVS PHARMACY	253130b4-a23b-43a0-b125-0fa5bd01b2b6	2026-01-15	Warnings	Exact identifier application applno (NDA): 020065 application number: NDA020065
Eye Allergy Relief	PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE	Walgreen Company	ddd892af-56d0-4755-af87-807ea8f8e9ca	2026-01-14	Warnings	Exact identifier application applno (NDA): 020065 application number: NDA020065
Eye Allergy Relief	PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE	Target Corporation	806ad1b6-0de7-4e9a-be86-475c0ef2c340	2025-03-28	Warnings	Exact identifier application applno (NDA): 020065 application number: NDA020065
Eye Allergy Relief	PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE	Rite Aid Corporation	6043040e-3206-40dd-aa87-940b1a84a496	2024-07-22	Warnings	Exact identifier application applno (NDA): 020065 application number: NDA020065 ndc (package): 11822-0552-1 ndc (product): 11822-0552 ndc11 (package): 11822055201
Opcon-A	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	Bausch & Lomb Incorporated	90a05c13-5b87-415b-9892-10d2edbc1943	2023-12-14	Warnings	Exact identifier application applno (NDA): 020065 application number: NDA020065
Eye Allergy Relief	PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE	Wal-Mart Stores Inc	873a072f-159b-44b8-aad8-33963d961afb	2021-04-05	Warnings	Exact identifier application applno (NDA): 020065 application number: NDA020065
Eye Allergy Relief	PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE	DOLGENCORP, LLC	82a99ff3-4f57-42e6-82f4-769d6418be7c	2020-01-27	Warnings	Exact identifier application applno (NDA): 020065 application number: NDA020065

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MZ1131787D	NAPHAZOLINE HYDROCHLORIDE	550-99-2	NAPHAZOLINE HYDROCHLORIDE
NYW905655B	PHENIRAMINE MALEATE	132-20-7	PHENIRAMINE MALEATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1043704	naphazoline HCl 0.02675 % / pheniramine maleate 0.315 % Ophthalmic Solution	PSN	6043040e-3206-40dd-aa87-940b1a84a496	5
1043704	naphazoline hydrochloride 0.27 MG/ML / pheniramine maleate 3.15 MG/ML Ophthalmic Solution	SCD	6043040e-3206-40dd-aa87-940b1a84a496	5
1043704	naphazoline HCl 0.02675 % / pheniramine maleate 0.315 % Ophthalmic Solution	SY	6043040e-3206-40dd-aa87-940b1a84a496	5
1043704	naphazoline HCl 0.027 % / pheniramine maleate 0.315 % Ophthalmic Solution	SY	6043040e-3206-40dd-aa87-940b1a84a496	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
11822-0552-1	11822055201	1 BOTTLE, DROPPER in 1 CARTON (11822-0552-1) > 15 mL in 1 BOTTLE, DROPPER	2015-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Rite Aid Corporation \| Bausch & Lomb Incorporated \| Loba Feinchemie AG	2024-07-22	HUMAN OTC DRUG LABEL	5