FDA.reportPublic FDA data

NDC 53208-442-01 - Sooryehan Pure-Whitening Essence

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
53208-442
Requested NDC
53208-442-01
Package NDCs from labels
53208-442-01, 53208-442-02
Manufacturer
LG Household and Healthcare, Inc.
Effective date
2010-05-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DRUG FACTSLG Household and Healthcare, Inc.2010-05-14HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53208-442-022019-10-21C16284748780-1956f9ecf-d563-621f-e053-dbdaa90a74adDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53208-442-01Sooryehan Pure-Whitening Essence45 mL in 1 CONTAINERCREAM453
53208-442-02Sooryehan Pure-Whitening Essence1 in 1 BOXCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53208-442SOORYEHAN PURE-WHITENING ESSENCE (POLYDATIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]3Legacy NDC, 2 package rows20100515_4d37af0d-b3d3-4392-95b9-d8e6a4b653ba.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POLYDATINACTIVE INGREDIENTXM261C37CQSOORYEHAN PURE-WHITENING ESSENCE (POLYDATIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]3
POLYDATINACTIVE MOIETYXM261C37CQSOORYEHAN PURE-WHITENING ESSENCE (POLYDATIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]3
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OSOORYEHAN PURE-WHITENING ESSENCE (POLYDATIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]3
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C40SOORYEHAN PURE-WHITENING ESSENCE (POLYDATIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]3
EDETATE TRISODIUMINACTIVE INGREDIENT420IP921MBSOORYEHAN PURE-WHITENING ESSENCE (POLYDATIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]3
ETHYLPARABENINACTIVE INGREDIENT14255EXE39SOORYEHAN PURE-WHITENING ESSENCE (POLYDATIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]3
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MSOORYEHAN PURE-WHITENING ESSENCE (POLYDATIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8SOORYEHAN PURE-WHITENING ESSENCE (POLYDATIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSOORYEHAN PURE-WHITENING ESSENCE (POLYDATIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSOORYEHAN PURE-WHITENING ESSENCE (POLYDATIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]3
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZSOORYEHAN PURE-WHITENING ESSENCE (POLYDATIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]3
POLYOXYL 40 HYDROGENATED CASTOR OILINACTIVE INGREDIENT7YC686GQ8FSOORYEHAN PURE-WHITENING ESSENCE (POLYDATIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]3
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKSOORYEHAN PURE-WHITENING ESSENCE (POLYDATIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RSOORYEHAN PURE-WHITENING ESSENCE (POLYDATIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]3

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 41 of 54 · 1,080 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMMeijer Distribution Incfb170371-2e5d-43ca-a259-538a973ee3b82024-10-15WarningsExact identifier
unii: PDC6A3C0OX
Target Up and Up Daily MoisturizingDIMETHICONETARGET CORPORATIONf118e0eb-1e66-50ab-e053-2995a90a2cb92024-10-14WarningsExact identifier
unii: 92RU3N3Y1O
topcare hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMTopco Associates LLC5e13da07-48cf-40bc-bb11-fd891886cbea2024-10-14WarningsExact identifier
unii: PDC6A3C0OX
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATERHubei Changjian Medical Products Co., Ltd.d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea2024-10-11WarningsExact identifier
unii: 059QF0KO0R
Bliss GVSGLYCERINBliss GVS Pharma Limited1a3982a1-9ce9-4a1a-ba73-ebe2d86471092024-10-10WarningsExact identifier
unii: PDC6A3C0OX
MeloxALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEBelmora LLCbfc78d44-dc90-4f69-85af-a23dd70c68d22024-10-04WarningsExact identifier
unii: 92RU3N3Y1O
DimopairDIMETHICONEPureTek Corporationdc16af56-b97d-c17f-e053-2995a90a55a02024-10-01WarningsExact identifier
unii: 92RU3N3Y1O
Skin Repair ComplexDIMETHICONEPureTek Corporation1c3059c5-5f7e-264e-e054-00144ff8d46c2024-10-01WarningsExact identifier
unii: 92RU3N3Y1O
Simethicone 80 mgSIMETHICONEProficient Rx LPa5e523b3-475e-4d28-a89c-c4325c59c9392024-10-01WarningsExact identifier
unii: 92RU3N3Y1O
good sense gas reliefSIMETHICONEL. Perrigo Company14caaf5a-6877-40f9-af8f-fb48de94ecfe2024-09-30WarningsExact identifier
unii: 92RU3N3Y1O
Household DetoxPTELEA TRIFOLIATA, ALLIUM SATIVUM, PETROLEUM, CARBONEUM SULPHURATUM, ALUMINA, BENZINUM, BISPHENOL A, CARBOLICUM ACIDUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PARAFFINUM, PHENACETINUM, SODIUM CARBOXYMETHYL CELLULOSE, FOLLICULINUM, ANTIPYRINUM, DIOXIN, DIETHYLSTILBESTROL, TEFLONDeseret Biologicals, Inc.7e32c1f4-c88e-43d0-9f6c-de736d358d462024-09-27WarningsExact identifier
unii: A2I8C7HI9T
hemorrhoidal maximum strength pain reliefGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMKroger Company3c8f90e2-fecf-4439-9faa-81a32ffe47532024-09-26WarningsExact identifier
unii: PDC6A3C0OX
equate hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMWal-Mart Stores Inc5ccefdbd-bbbe-4cbf-9fdb-3c568643e14d2024-09-26WarningsExact identifier
unii: PDC6A3C0OX
Walgreens Hemorrhoidal Pain ReliefGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Walgreense79ed7ae-0d06-2f88-e053-2995a90a1e352024-09-20WarningsExact identifier
unii: PDC6A3C0OX
SootheGLYCERIN AND PROPYLENE GLYCOLBausch & Lomb Incorporatedfef002ea-c4bd-4486-a42e-1bbd9d73d28d2024-09-20WarningsExact identifier
unii: PDC6A3C0OX
Aveeno Baby Daily MoistureDIMETHICONEKenvue Brands LLCb34c8e71-7fad-484c-b387-3c424f50b7432024-09-19WarningsExact identifier
unii: 92RU3N3Y1O
Care One Gas ReliefSIMETHICONEAmerican Sales Companyf42c8c2a-4ffd-465e-bb93-05ed65ba76f02024-09-15WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONEPublix Super Markets Incaafa7da9-53d7-478a-805e-e68cdf54ed2b2024-09-14WarningsExact identifier
unii: 92RU3N3Y1O
basic care gas reliefSIMETHICONEAmazon.com Services LLC6cd13797-207b-41fa-8dc1-5688f6b861492024-09-14WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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