FDA.reportPublic FDA data

Redness reliever

Product NDC
51134-0062
11-digit product format
511340062
Labeler code
51134
Product ID
51134-0062_e5610d61-6b49-48c3-8e0d-127a499e0d79
Type
HUMAN OTC DRUG
Nonproprietary name
tetrahydrozoline HCl
Dosage form
LIQUID
Route
OPHTHALMIC
Labeler
Samchundang Pharm. Co., Ltd.
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-08-29
Marketing end
0000-00-00
Substance
TETRAHYDROZOLINE HYDROCHLORIDE
Active strength
1 mg/mL
NDC exclude flag
E
Listing certified through
2017-12-31
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
51134-0062-52019-10-29C16284748780-1960f7f55-c6b0-8e05-e053-dbdaa90a074aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51134-0062-5Redness reliever15 mL in 1 BOTTLELIQUID151
51134-0062-5Redness reliever1 in 1 BOXLIQUID11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TETRAHYDROZOLINE HYDROCHLORIDEACTIVE INGREDIENT0YZT43HS7DREDNESS RELIEVER (TETRAHYDROZOLINE HCL) LIQUID [SAMCHUNDANG PHARM. CO., LTD.]1
TETRAHYDROZOLINEACTIVE MOIETYS9U025Y077REDNESS RELIEVER (TETRAHYDROZOLINE HCL) LIQUID [SAMCHUNDANG PHARM. CO., LTD.]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7REDNESS RELIEVER (TETRAHYDROZOLINE HCL) LIQUID [SAMCHUNDANG PHARM. CO., LTD.]1
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4REDNESS RELIEVER (TETRAHYDROZOLINE HCL) LIQUID [SAMCHUNDANG PHARM. CO., LTD.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KREDNESS RELIEVER (TETRAHYDROZOLINE HCL) LIQUID [SAMCHUNDANG PHARM. CO., LTD.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBREDNESS RELIEVER (TETRAHYDROZOLINE HCL) LIQUID [SAMCHUNDANG PHARM. CO., LTD.]1
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QOREDNESS RELIEVER (TETRAHYDROZOLINE HCL) LIQUID [SAMCHUNDANG PHARM. CO., LTD.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XREDNESS RELIEVER (TETRAHYDROZOLINE HCL) LIQUID [SAMCHUNDANG PHARM. CO., LTD.]1
WATERINACTIVE INGREDIENT059QF0KO0RREDNESS RELIEVER (TETRAHYDROZOLINE HCL) LIQUID [SAMCHUNDANG PHARM. CO., LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51134-0062REDNESS RELIEVER (TETRAHYDROZOLINE HCL) LIQUID [SAMCHUNDANG PHARM. CO., LTD.]1Legacy NDC, 2 package rows20101026_bdd5ce35-dedf-4a52-9252-669d98bbabe5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1052943tetrahydrozoline HCl 0.05 % Ophthalmic SolutionPSNbdd5ce35-dedf-4a52-9252-669d98bbabe51
1052943tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCDbdd5ce35-dedf-4a52-9252-669d98bbabe51
1052943tetrahydrozoline hydrochloride 0.05 % Eye DropsSYbdd5ce35-dedf-4a52-9252-669d98bbabe51
1052943tetrahydrozoline hydrochloride 0.05 % Ophthalmic SolutionSYbdd5ce35-dedf-4a52-9252-669d98bbabe51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
51134-0062-55113400620515 mL in 1 BOTTLE15 mlHistorical