FDA.reportPublic FDA data

CAREALL Eyedrops Original

Product NDC
51824-039
11-digit product format
518240039
Labeler code
51824
Product ID
51824-039_4baa2919-7f22-49c2-a48d-d6be85f74d23
Type
HUMAN OTC DRUG
Nonproprietary name
Tetrahydrozoline HCI
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
New World Imports, Inc
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-06-01
Marketing end
0000-00-00
Substance
TETRAHYDROZOLINE HYDROCHLORIDE
Active strength
1 mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51824-039DDiscontinued by firm2026-10-12
excluded packagepackage51824-03951824-039-05DDiscontinued by firm2026-10-12

Reported adverse events (FAERS/openFDA)#

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

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
51824-039-05CAREALL Eyedrops Original15 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS157

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TETRAHYDROZOLINE HYDROCHLORIDEACTIVE INGREDIENT0YZT43HS7DCAREALL EYEDROPS ORIGINAL (TETRAHYDROZOLINE HCI) SOLUTION/ DROPS [NEW WORLD IMPORTS, INC]1
TETRAHYDROZOLINEACTIVE MOIETYS9U025Y077CAREALL EYEDROPS ORIGINAL (TETRAHYDROZOLINE HCI) SOLUTION/ DROPS [NEW WORLD IMPORTS, INC]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7CAREALL EYEDROPS ORIGINAL (TETRAHYDROZOLINE HCI) SOLUTION/ DROPS [NEW WORLD IMPORTS, INC]1
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4CAREALL EYEDROPS ORIGINAL (TETRAHYDROZOLINE HCI) SOLUTION/ DROPS [NEW WORLD IMPORTS, INC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCAREALL EYEDROPS ORIGINAL (TETRAHYDROZOLINE HCI) SOLUTION/ DROPS [NEW WORLD IMPORTS, INC]1
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QOCAREALL EYEDROPS ORIGINAL (TETRAHYDROZOLINE HCI) SOLUTION/ DROPS [NEW WORLD IMPORTS, INC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCAREALL EYEDROPS ORIGINAL (TETRAHYDROZOLINE HCI) SOLUTION/ DROPS [NEW WORLD IMPORTS, INC]1
WATERINACTIVE INGREDIENT059QF0KO0RCAREALL EYEDROPS ORIGINAL (TETRAHYDROZOLINE HCI) SOLUTION/ DROPS [NEW WORLD IMPORTS, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51824-039CAREALL EYEDROPS ORIGINAL (TETRAHYDROZOLINE HCI) SOLUTION/ DROPS [NEW WORLD IMPORTS, INC]7Legacy NDC, 1 package rows20241009_8aad89f9-d29c-4668-b58d-8dc0d266bc01.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1052943tetrahydrozoline HCl 0.05 % Ophthalmic SolutionPSN8aad89f9-d29c-4668-b58d-8dc0d266bc017
1052943tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCD8aad89f9-d29c-4668-b58d-8dc0d266bc017
1052943tetrahydrozoline hydrochloride 0.05 % Eye DropsSY8aad89f9-d29c-4668-b58d-8dc0d266bc017
1052943tetrahydrozoline hydrochloride 0.05 % Ophthalmic SolutionSY8aad89f9-d29c-4668-b58d-8dc0d266bc017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51824-039-055182400390515 mL in 1 BOTTLE, PLASTIC (51824-039-05) 15 ml2014-06-010000-00-00NoNoCurrent