Visine A

Product NDC: 42002-200
11-digit product format: 420020200
Labeler code: 42002
Product ID: 42002-200_db1f7543-bc7b-4383-b2dc-a25db8b8a5a2
Type: HUMAN OTC DRUG
Nonproprietary name: Naphazoline Hydrochloride and Pheniramine Maleate
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Johnson & Johnson Consumer Inc.
Application: NDA020485
Marketing category: NDA
Marketing start: 2010-12-15
Marketing end: 0000-00-00
Substance: NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE
Active strength: 0 mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	42002-200		D	Discontinued by firm	2026-08-11
excluded package	package	42002-200	42002-200-05	D	Discontinued by firm	2026-08-11
excluded package	package	42002-200	42002-200-13	D	Discontinued by firm	2026-08-11

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42002-200-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42002-200-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42002-200-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42002-200-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42002-200-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42002-200-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42002-200-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42002-200-13	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42002-200-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42002-200-13	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42002-200-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42002-200-13	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42002-200-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42002-200-13	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42002-200-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42002-200-13	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42002-200-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42002-200-13	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42002-200-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42002-200-13	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42002-200-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42002-200-13	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42002-200-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42002-200-13	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N020485-001	VISINE	NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	1996-01-31

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020485-001	VISINE	0.025%;0.3%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	1996-01-31	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42002-200-05	ML - Milliliter	42002-200	a2034c97-1169-4d60-8761-b6bb536be54b	1	2017-07-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Naphazoline Hydrochloride	ACTIVE INGREDIENT	MZ1131787D	VISINE A MULTI-ACTION EYE ALLERGY RELIEF (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [JOHNSON & JOHNSON CONSUMER INC.]	5
Pheniramine Maleate	ACTIVE INGREDIENT	NYW905655B	VISINE A MULTI-ACTION EYE ALLERGY RELIEF (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [JOHNSON & JOHNSON CONSUMER INC.]	5
Naphazoline	ACTIVE MOIETY	H231GF11BV	VISINE A MULTI-ACTION EYE ALLERGY RELIEF (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [JOHNSON & JOHNSON CONSUMER INC.]	5
Pheniramine	ACTIVE MOIETY	134FM9ZZ6M	VISINE A MULTI-ACTION EYE ALLERGY RELIEF (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [JOHNSON & JOHNSON CONSUMER INC.]	5
Benzalkonium Chloride	INACTIVE INGREDIENT	F5UM2KM3W7	VISINE A MULTI-ACTION EYE ALLERGY RELIEF (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [JOHNSON & JOHNSON CONSUMER INC.]	5
Boric Acid	INACTIVE INGREDIENT	R57ZHV85D4	VISINE A MULTI-ACTION EYE ALLERGY RELIEF (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [JOHNSON & JOHNSON CONSUMER INC.]	5
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	VISINE A MULTI-ACTION EYE ALLERGY RELIEF (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [JOHNSON & JOHNSON CONSUMER INC.]	5
Hydrochloric Acid	INACTIVE INGREDIENT	QTT17582CB	VISINE A MULTI-ACTION EYE ALLERGY RELIEF (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [JOHNSON & JOHNSON CONSUMER INC.]	5
Sodium Borate	INACTIVE INGREDIENT	91MBZ8H3QO	VISINE A MULTI-ACTION EYE ALLERGY RELIEF (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [JOHNSON & JOHNSON CONSUMER INC.]	5
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	VISINE A MULTI-ACTION EYE ALLERGY RELIEF (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [JOHNSON & JOHNSON CONSUMER INC.]	5
Water	INACTIVE INGREDIENT	059QF0KO0R	VISINE A MULTI-ACTION EYE ALLERGY RELIEF (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [JOHNSON & JOHNSON CONSUMER INC.]	5

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Visine Allergy Eye Relief Multi-Action	NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	Kenvue Brands LLC	125fbc97-5bc8-436e-9ee9-e5a44384e260	2024-11-13	Warnings	Exact identifier application applno (NDA): 020485 application number: NDA020485

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Visine®-A® MULTI-ACTION EYE ALLERGY Relief	REMEDYREPACK INC.	2017-11-02	HUMAN OTC DRUG LABEL	1
Visine®-A® MULTI-ACTION EYE ALLERGY Relief	Johnson & Johnson Consumer Inc.	2016-03-24	HUMAN OTC DRUG LABEL	6