FDA.reportPublic FDA data

Fluorescein Sodium and Benoxinate Hydrochloride

Product NDC
82260-734
11-digit product format
822600734
Labeler code
82260
Product ID
82260-734_34f4e654-be4a-0c13-e063-6394a90a629d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluorescein Sodium and Benoxinate Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Bausch & Lomb Americas Inc.
Application
NDA211039
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-03-20
Substance
BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM
Active strength
4.4; 2.6 mg/mL; mg/mL
Pharmacologic classes
Diagnostic Dye [EPC], Dyes [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluorescein Sodium and Benoxinate Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUORESCEIN SODIUM4.4 mg/mL
BENOXINATE HYDROCHLORIDE2.6 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii93X55PE38X, 0VE4U49K15
Rxcui2287005

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8f43a274-9585-47cb-b427-0eb3e578384dProduct name120250623
4a998fa9-995e-4ea5-97ef-93a559305758Product name120200706
c94ccba7-2a03-4a3e-a891-d62a57340fb2Product name120180215

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82260-734-05Fluorescein Sodium and Benoxinate Hydrochloride1 in 1 CARTONSOLUTION/ DROPS14
82260-734-05Fluorescein Sodium and Benoxinate Hydrochloride5 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82260-734-05ML - Milliliter82260-7342c981e16-0bd4-40e7-a889-f27a408812bf12025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82260-734FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB AMERICAS INC.]4Current NDC, 2 package rows20250514_f935b5f8-dc6e-4425-a668-968ee3855f51.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2287005benoxinate HCl 0.4 % / fluorescein sodium 0.3 % Ophthalmic SolutionPSNf935b5f8-dc6e-4425-a668-968ee3855f514
2287005benoxinate hydrochloride 4 MG/ML / fluorescein sodium 3 MG/ML Ophthalmic SolutionSCDf935b5f8-dc6e-4425-a668-968ee3855f514
2287005benoxinate hydrochloride 0.4 % / fluorescein sodium 0.3 % Ophthalmic DropsSYf935b5f8-dc6e-4425-a668-968ee3855f514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82260-734-05822600734051 BOTTLE, GLASS in 1 CARTON (82260-734-05) / 5 mL in 1 BOTTLE, GLASS2020-03-20NoNoCurrent