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 25 of 55 · 1,091 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlycerinGLYCERINDSC Laboratories Inc.a381838b-d1ae-11c5-e053-2a95a90a7bcb2025-10-24WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINAmerisource Bergen/Good Neighbor Pharmacy90a4d385-d548-420b-91d2-54d5e819fcce2025-10-24WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINCVS Pharmacy3a59c4a9-5f86-406a-e054-00144ff8d46c2025-10-24WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINCardinal Health7e7e9366-af1e-e0ff-e053-2a91aa0a94872025-10-24WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINCardinal Healthc2b02afc-5a8a-2a25-e053-2a95a90ae45c2025-10-24WarningsExact identifier
unii: PDC6A3C0OX
Signature Care Hemorrhoidal Cream (with applicator)PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, GLYCERIN, PETROLATUMBETTER LIVING BRANDS, LLCb026a386-5e38-52ed-e053-2a95a90a6b0e2025-10-24WarningsExact identifier
unii: PDC6A3C0OX
Lemon Glycerine SwabsticksGLYCERINEPHOENIX HEALTHCARE SOLUTIONS, LLC436919f7-14cd-4318-9388-b3e1cbec176b2025-10-23WarningsExact identifier
unii: PDC6A3C0OX
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEIMO-GEN LABS LLC41d6dba5-e411-c8d2-e063-6294a90ae8fa2025-10-23WarningsExact identifier
unii: 92RU3N3Y1O
Advanced Eye Relief Dry Eye RejuvenationGLYCERIN PROPYLENE GLYCOLBausch & Lomb Incorporated027969ee-64e4-4b08-bab7-c4cc8ed22f5f2025-10-23WarningsExact identifier
unii: PDC6A3C0OX
PHAZYMESIMETHICONEC.B. Fleet Company, Inc.ea04f5a5-cf56-4176-a234-5a73e01ff2182025-10-23WarningsExact identifier
unii: 92RU3N3Y1O
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Refresh Relieva Preservative FreeCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.3481f9b3-5a90-40d3-80f8-81f51cc864be2025-10-22WarningsExact identifier
unii: PDC6A3C0OX
JAFRA Fruteria Coco Fresco Lip BalmDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.9895a320-8a74-4b27-9bf1-4b492f89888c2025-10-21WarningsExact identifier
unii: 92RU3N3Y1O
JAFRA Fruteria So CitricoDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.a68d6cda-2268-440a-9ca6-677c4e3ea0e72025-10-21WarningsExact identifier
unii: 92RU3N3Y1O
JAFRA Fruteria Very Verde Lip BalmDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.4f0de70b-7ebe-4381-9b46-d5b334f426e02025-10-21WarningsExact identifier
unii: 92RU3N3Y1O
GlycerinGLYCERINChain Drug Consortium LLC4694f05b-d927-4e15-9630-a0a1cddb3cbb2025-10-16WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINAmerisource Bergen/Good Neighbor Pharmacye6a8914f-cfd9-4c72-abaa-22189bf0faef2025-10-16WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINChain Drug Marketing Association Inc.3386fada-6b7f-46fd-e063-6294a90abffc2025-10-16WarningsExact identifier
unii: PDC6A3C0OX
Cardinal Health Infants Gas ReliefSIMETHICONECARDINAL HEALTHe0dec270-dabb-4289-b5e0-bf37f9ddcbcd2025-10-14WarningsExact identifier
unii: 92RU3N3Y1O
FinaftaBENZOCAINE, GLYCERINEfficient Laboratories Inc.03368603-3e11-c2fa-e063-6294a90a04ea2025-10-14WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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