FDA.reportPublic FDA data

FREDS ORIGINAL EYE DROPS

Product NDC
11716-1187
11-digit product format
117161187
Labeler code
11716
Product ID
11716-1187_cb039152-7e0b-498a-9d68-aabd9a8e4c59
Type
HUMAN OTC DRUG
Nonproprietary name
TETRAHYDROZOLINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
HANLIM PHARM. CO., LTD.
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-05-14
Marketing end
0000-00-00
Substance
TETRAHYDROZOLINE HYDROCHLORIDE
Active strength
1 mg/mL
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11716-1187-82020-01-31C16284748780-19d75b9d1-0c5a-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11716-1187-8FREDS ORIGINAL EYE DROPS15 mL in 1 BOTTLESOLUTION152
11716-1187-8FREDS ORIGINAL EYE DROPS1 in 1 CARTONSOLUTION12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TETRAHYDROZOLINE HYDROCHLORIDEACTIVE INGREDIENT0YZT43HS7DFREDS ORIGINAL EYE DROPS (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [HANLIM PHARM. CO., LTD.]2
TETRAHYDROZOLINEACTIVE MOIETYS9U025Y077FREDS ORIGINAL EYE DROPS (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [HANLIM PHARM. CO., LTD.]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7FREDS ORIGINAL EYE DROPS (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [HANLIM PHARM. CO., LTD.]2
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4FREDS ORIGINAL EYE DROPS (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [HANLIM PHARM. CO., LTD.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KFREDS ORIGINAL EYE DROPS (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [HANLIM PHARM. CO., LTD.]2
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QOFREDS ORIGINAL EYE DROPS (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [HANLIM PHARM. CO., LTD.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XFREDS ORIGINAL EYE DROPS (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [HANLIM PHARM. CO., LTD.]2
WATERINACTIVE INGREDIENT059QF0KO0RFREDS ORIGINAL EYE DROPS (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [HANLIM PHARM. CO., LTD.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11716-1187FREDS ORIGINAL EYE DROPS (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [HANLIM PHARM. CO., LTD.]2Legacy NDC, 2 package rows20100517_b4115c28-4249-4869-80ab-c23c91d39acf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1052943tetrahydrozoline HCl 0.05 % Ophthalmic SolutionPSNb4115c28-4249-4869-80ab-c23c91d39acf2
1052943tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCDb4115c28-4249-4869-80ab-c23c91d39acf2
1052943tetrahydrozoline hydrochloride 0.05 % Eye DropsSYb4115c28-4249-4869-80ab-c23c91d39acf2
1052943tetrahydrozoline hydrochloride 0.05 % Ophthalmic SolutionSYb4115c28-4249-4869-80ab-c23c91d39acf2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
11716-1187-81171611870815 mL in 1 BOTTLE15 mlHistorical