FDA.reportPublic FDA data

Visine Allergy Eye Relief Multi-Action

Product NDC
69968-0367
11-digit product format
699680367
Labeler code
69968
Product ID
69968-0367_21eaa17e-eb96-aa1d-e063-6394a90a9870
Type
HUMAN OTC DRUG
Nonproprietary name
Naphazoline Hydrochloride and Pheniramine Maleate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Kenvue Brands LLC
Application
NDA020485
Marketing category
NDA
Marketing start
2019-05-06
Substance
NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE
Active strength
.25; 3 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Visine Allergy Eye Relief Multi-Action
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPHAZOLINE HYDROCHLORIDE.25 mg/mL
PHENIRAMINE MALEATE3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMZ1131787D, NYW905655B
Rxcui1043658

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043658naphazoline HCl 0.025 % / pheniramine maleate 0.3 % Ophthalmic SolutionPSN125fbc97-5bc8-436e-9ee9-e5a44384e2608
1043658naphazoline hydrochloride 0.25 MG/ML / pheniramine maleate 3 MG/ML Ophthalmic SolutionSCD125fbc97-5bc8-436e-9ee9-e5a44384e2608
1043658naphazoline hydrochloride 0.025 % / pheniramine maleate 0.3 % Ophthalmic SolutionSY125fbc97-5bc8-436e-9ee9-e5a44384e2608

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69968-0367-1699680367011 BOTTLE in 1 CARTON (69968-0367-1) / 15 mL in 1 BOTTLE1 bottle2019-05-060000-00-00NoNoCurrent
69968-0367-2699680367022 BOTTLE in 1 CARTON (69968-0367-2) / 15 mL in 1 BOTTLE2 bottle2019-06-030000-00-00NoNoCurrent