FDA.reportPublic FDA data

Equaline Multi-Symptom Eye Drops

Product NDC
83455-207
11-digit product format
834550207
Labeler code
83455
Product ID
83455-207_474a9e15-235b-5608-e063-6294a90a9632
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene glycol 400, Tetrahydrozoline HCl, Zinc sulfate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
United Natural Foods, Inc.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-20
Substance
POLYETHYLENE GLYCOL 400; TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE
Active strength
1; .05; .25 g/100mL; g/100mL; g/100mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC SULFATE1 g/100mL
POLYETHYLENE GLYCOL 400.05 g/100mL
TETRAHYDROZOLINE HYDROCHLORIDE.25 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89DS0H96TB, B697894SGQ, 0YZT43HS7D
Rxcui2360903

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
83455-207-01Equaline Multi-Symptom Eye Drops15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS153
83455-207-01Equaline Multi-Symptom Eye Drops1 in 1 BOXSOLUTION/ DROPS13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83455-207EQUALINE MULTI-SYMPTOM EYE DROPS (POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATE) SOLUTION/ DROPS [UNITED NATURAL FOODS, INC.]2Current NDC, 2 package rows20240209_fe467606-6d66-b695-e053-6294a90aab5d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2360903polyethylene glycol 400 1 % / tetrahydrozoline hydrochloride 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionPSNfe467606-6d66-b695-e053-6294a90aab5d3
2360903polyethylene glycol 400 10 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML / zinc sulfate 2.5 MG/ML Ophthalmic SolutionSCDfe467606-6d66-b695-e053-6294a90aab5d3
2360903polyethylene glycol 400 1 % / tetrahydrozoline hydrochloride 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionSYfe467606-6d66-b695-e053-6294a90aab5d3
2360903polyethylene glycol 400 10 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML / ZnSO4 2.5 MG/ML Ophthalmic SolutionSYfe467606-6d66-b695-e053-6294a90aab5d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83455-207-01834550207011 BOTTLE, DROPPER in 1 BOX (83455-207-01) / 15 mL in 1 BOTTLE, DROPPER2023-06-20NoNoHistorical