Eye Allergy Relief

Product NDC: 49035-430
11-digit product format: 490350430
Labeler code: 49035
Product ID: 49035-430_e3cef1db-322d-45e0-b39f-442af74ee5b7
Type: HUMAN OTC DRUG
Nonproprietary name: Pheniramine Maleate and Naphazoline Hydrochloride
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Wal-Mart Stores Inc
Application: NDA020065
Marketing category: NDA
Marketing start: 2010-08-31
Substance: NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE
Active strength: .2675; 3.15 mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	49035-430	49035-430-30	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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.

Additional Listing Data#

Finished product: Yes
Brand name base: Eye Allergy Relief
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NAPHAZOLINE HYDROCHLORIDE	.2675 mg/mL
PHENIRAMINE MALEATE	3.15 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
MZ1131787D	Internal UNII lookup
NYW905655B	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1043704	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
873a072f-159b-44b8-aad8-33963d961afb	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49035-430-15	Eye Allergy Relief	15 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	15	7
49035-430-15	Eye Allergy Relief	1 in 1 CARTON	SOLUTION/ DROPS	1	7
49035-430-30	Eye Allergy Relief	2 in 1 CARTON	SOLUTION/ DROPS	2	7
49035-430-30	Eye Allergy Relief	15 mL in 1 BOTTLE	SOLUTION/ DROPS	15	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49035-430-15	ML - Milliliter	49035-430	c1c9375e-0080-46cb-9c56-65202ea7f091	1	2013-05-02

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 [WAL-MART STORES INC]	3
PHENIRAMINE MALEATE	ACTIVE INGREDIENT	NYW905655B	EYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [WAL-MART STORES INC]	3
NAPHAZOLINE	ACTIVE MOIETY	H231GF11BV	EYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [WAL-MART STORES INC]	3
PHENIRAMINE	ACTIVE MOIETY	134FM9ZZ6M	EYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [WAL-MART STORES INC]	3
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	EYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [WAL-MART STORES INC]	3
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	EYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [WAL-MART STORES INC]	3
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	EYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [WAL-MART STORES INC]	3
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	EYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [WAL-MART STORES INC]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	EYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [WAL-MART STORES INC]	3
SODIUM BORATE	INACTIVE INGREDIENT	91MBZ8H3QO	EYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [WAL-MART STORES INC]	3
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	EYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [WAL-MART STORES INC]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	EYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [WAL-MART STORES INC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49035-430	EYE ALLERGY RELIEF (PHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [WAL-MART STORES INC]	7	Current NDC, Legacy NDC, 4 package rows	20210406_873a072f-159b-44b8-aad8-33963d961afb.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
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 ndc (product): 49035-430
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	873a072f-159b-44b8-aad8-33963d961afb	7
1043704	naphazoline hydrochloride 0.27 MG/ML / pheniramine maleate 3.15 MG/ML Ophthalmic Solution	SCD	873a072f-159b-44b8-aad8-33963d961afb	7
1043704	naphazoline HCl 0.02675 % / pheniramine maleate 0.315 % Ophthalmic Solution	SY	873a072f-159b-44b8-aad8-33963d961afb	7
1043704	naphazoline HCl 0.027 % / pheniramine maleate 0.315 % Ophthalmic Solution	SY	873a072f-159b-44b8-aad8-33963d961afb	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
49035-430-15	49035043015	1 BOTTLE, DROPPER in 1 CARTON (49035-430-15) / 15 mL in 1 BOTTLE, DROPPER	2010-08-31	0000-00-00	No	No	Current
49035-430-30	49035043030	2 in 1 CARTON					Historical