Equaline Sterile Eye Drops

Product NDC
83455-210
11-digit product format
834550210
Labeler code
83455
Product ID
83455-210_31a25f09-2524-067d-e063-6294a90a24d8
Type
HUMAN OTC DRUG
Nonproprietary name
Tetrahydrozoline HCl
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
United Natural Foods, Inc.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-01
Substance
TETRAHYDROZOLINE HYDROCHLORIDE
Active strength
.05 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Equaline Sterile Eye Drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TETRAHYDROZOLINE HYDROCHLORIDE.05 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0YZT43HS7D
Rxcui1052943

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83455-210-01Equaline Sterile Eye Drops1 in 1 BOXSOLUTION/ DROPS11
83455-210-01Equaline Sterile Eye Drops15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83455-210EQUALINE STERILE EYE DROPS (TETRAHYDROZOLINE HCL) SOLUTION/ DROPS [UNITED NATURAL FOODS, INC.]1Current NDC, 2 package rows20250402_31a25efb-a627-1a13-e063-6394a90a2ca3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1052943tetrahydrozoline HCl 0.05 % Ophthalmic SolutionPSN31a25efb-a627-1a13-e063-6394a90a2ca31
1052943tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCD31a25efb-a627-1a13-e063-6394a90a2ca31
1052943tetrahydrozoline hydrochloride 0.05 % Eye DropsSY31a25efb-a627-1a13-e063-6394a90a2ca31
1052943tetrahydrozoline hydrochloride 0.05 % Ophthalmic SolutionSY31a25efb-a627-1a13-e063-6394a90a2ca31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83455-210-01834550210011 BOTTLE, DROPPER in 1 BOX (83455-210-01) / 15 mL in 1 BOTTLE, DROPPER2024-01-01NoNoCurrent