CAREALL Eyedrops Original

Product NDC
51824-039
Requested package NDC
51824-039-05
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 · 1 matching rows.

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

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#

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CAREALL Eyedrops OriginalTETRAHYDROZOLINE HCINew World Imports, Inc8aad89f9-d29c-4668-b58d-8dc0d266bc012024-10-07WarningsExact identifier
ndc (package): 51824-039-05
ndc (product): 51824-039
ndc11 (package): 51824003905

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