FDA.reportPublic FDA data

Visine Allergy Eye Relief Multi-Action

Manufacturer
Kenvue Brands LLC
Effective date
2024-11-13
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:36:57

Label at a glance#

ProductVisine Allergy Eye Relief Multi-Action
Active ingredientNAPHAZOLINE HYDROCHLORIDE, PHENIRAMINE MALEATE
Label structure10 sections

Indications and uses

Temporarily relieves itchy, red eyes due to: pollen ragweed grass animal hair and dander

Dosage and administration

adults and children 6 years of age and over: put 1 or 2 drops in the affected eye(s) up to 4 times a day children under 6 years of age: consult a doctor

Storage and handling

Store at 15° to 25°C (59° to 77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Naphazoline HCl 0.025%Redness reliever
Pheniramine maleate 0.3%Antihistamine

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves itchy, red eyes due to:

  • pollen
  • ragweed
  • grass
  • animal hair and dander

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use if you are sensitive to any ingredient in this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • heart disease
  • high blood pressure
  • narrow angle glaucoma
  • trouble urinating

When using this product

OTC - WHEN USING SECTION

  • pupils may become enlarged temporarily causing light sensitivity
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use
  • remove contact lenses before using
  • do not use if this solution changes color or becomes cloudy
  • overuse may cause more eye redness
  • some users may experience a brief tingling sensation

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye lasts
  • condition worsens or lasts more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. Accidental swallowing by infants and children may lead to coma and marked reduction in body temperature.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 6 years of age and over: put 1 or 2 drops in the affected eye(s) up to 4 times a day
  • children under 6 years of age: consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • Store at 15° to 25°C (59° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium hydroxide and/or hydrochloric acid

Questions?

OTC - QUESTIONS SECTION

call toll-free 888-734-7648 or 215-273-8755 (collect)

SPL UNCLASSIFIED SECTION

Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VISINE ®

NAPHAZOLINE HCl 0.025%

AND PHENIRAMINE MALEATE 0.3%

OPHTHALMIC SOLUTION

ANTIHISTAMINE AND REDNESS RELIEVER

ALLERGY EYE RELIEF

MULTI-ACTION

ORIGINAL

PRESCRIPTION STRENGTH

Clinically Proven to

Relieve Red,

Itchy Eyes

STERILE

EYE DROPS

1/2 FL OZ (15mL)

03670367

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043658naphazoline HCl 0.025 % / pheniramine maleate 0.3 % Ophthalmic SolutionPSN8
1043658naphazoline hydrochloride 0.25 MG/ML / pheniramine maleate 3 MG/ML Ophthalmic SolutionSCD8
1043658naphazoline hydrochloride 0.025 % / pheniramine maleate 0.3 % Ophthalmic SolutionSY8

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e18001c8-33ae-5f66-9cdc-a39724bd4573Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0367-1Visine Allergy Eye Relief Multi-Action15 mL in 1 BOTTLESOLUTION/ DROPS158
69968-0367-1Visine Allergy Eye Relief Multi-Action1 in 1 CARTONSOLUTION/ DROPS18
69968-0367-2Visine Allergy Eye Relief Multi-Action15 mL in 1 BOTTLESOLUTION/ DROPS158
69968-0367-2Visine Allergy Eye Relief Multi-Action2 in 1 CARTONSOLUTION/ DROPS28

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0367VISINE ALLERGY EYE RELIEF MULTI-ACTION (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [KENVUE BRANDS LLC]8Current NDC, Legacy NDC, 4 package rows20241115_125fbc97-5bc8-436e-9ee9-e5a44384e260.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69968-0367-1ML - Milliliter69968-0367d8880fe0-626f-4119-a96f-0dc0a9b52daf12020-01-03
69968-0367-2ML - Milliliter69968-0367ce126ce6-a578-4f93-a3b3-c2f3ef023cdb12022-06-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-036769968-0367-1, 69968-0367-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
BORIC ACIDR57ZHV85D4IACT
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT
SODIUM BORATE91MBZ8H3QOIACT
SODIUM HYDROXIDE55X04QC32IIACT
HYDROCHLORIC ACIDQTT17582CBIACT
NAPHAZOLINE HYDROCHLORIDEMZ1131787DACTIB
PHENIRAMINE MALEATENYW905655BACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020485-001VISINENAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-31

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-3184e616aacf4f…
2026-08-18 06:07:402026-07N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-3187673890dc5c…
2021-03-12 10:30 UTC2021-03N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-313f01610625f2…
2019-09-15 20:21 UTC2019-09N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-31b00525d2431f…
2019-07-19 19:46 UTC2019-07N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-313f0d92c62455…
2023-05-13 08:27 UTC2023-05N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-31053a50430f4f…
2023-01-26 05:58 UTC2023-01N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-31f41ea6bd6efb…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Visine Allergy Eye Relief Multi-ActionNAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATEKenvue Brands LLC125fbc97-5bc8-436e-9ee9-e5a44384e2602024-11-13WarningsExact identifier
ndc (package): 69968-0367-2
ndc (package): 69968-0367-1
ndc (product): 69968-0367
ndc11 (package): 69968036701
ndc11 (package): 69968036702
spl id: 21eaa17e-eb96-aa1d-e063-6394a90a9870
spl set id: 125fbc97-5bc8-436e-9ee9-e5a44384e260

Reported adverse events (FAERS/openFDA)#

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