FDA.reportPublic FDA data

Visine A

Manufacturer
REMEDYREPACK INC.
Effective date
2017-11-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:10:38

Label at a glance#

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

Dosage and administration

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

Storage and handling

some users may experience a brief tingling sensation 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

Use

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 due to an enlarged prostate gland

When using this product

OTC - WHEN USING SECTION

  • pupils may become enlarged temporarily
  • 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

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 four times a day
  • children under 6 years of age: consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • some users may experience a brief tingling sensation
  • 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)

Caution

SPL UNCLASSIFIED SECTION

Do not use if VISINE ® imprinted neckband on bottle is broken or missing.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Visine AMulti-Action Eye Allergy Relief Multi-Action Eye Allergy Relief

GENERIC: Naphazoline Hydrochloride and Pheniramine Maleate

DOSAGE: SOLUTION/ DROPS

ADMINSTRATION: OPHTHALMIC

NDC: 70518-0817-0

PACKAGING: 15 mL in 1 BOTTLE, DROPPER

ACTIVE INGREDIENT(S):

  • Naphazoline Hydrochloride 0.25mg in 1mL
  • Pheniramine Maleate 3mg in 1mL

INACTIVE INGREDIENT(S):

  • Boric Acid
  • Hydrochloric Acid
  • Sodium Hydroxide
  • Edetate Disodium
  • Benzalkonium Chloride
  • Sodium Borate
  • Water

Remedy_LabelRemedy_Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-0817-02020-05-06C16284748780-19d75b9d0-8ce0-f424-e053-dadaa90a57ceVisine®-A® MULTI-ACTION EYE ALLERGY Relief
70518-0817-02020-01-31C16284748780-19d75b9d0-8ce0-f424-e053-dadaa90a57ceVisine®-A® MULTI-ACTION EYE ALLERGY Relief

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42002-200-05ML - Milliliter42002-200a2034c97-1169-4d60-8761-b6bb536be54b12017-07-07

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
70518-081770518-0817-0
42002-200

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
BORIC ACIDR57ZHV85D4IACT
SODIUM BORATE91MBZ8H3QOIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM HYDROXIDE55X04QC32IIACT
HYDROCHLORIC ACIDQTT17582CBIACT
WATER059QF0KO0RIACT
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
a4fad237-66ba-279a-e053-2995a90a6ed49c52c855-adcc-4b72-9d7d-a5fb8cf061542020-05-06WarningsExact identifier
spl set id: 9c52c855-adcc-4b72-9d7d-a5fb8cf06154

Reported adverse events (FAERS/openFDA)#

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