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 1 of 57 · 1,124 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic MultipurposeDIMETHICONEL'Oreal USA Products Inc805cd262-2689-4818-8fed-ddefacbdde232026-09-10WarningsExact identifier
unii: 92RU3N3Y1O
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic MultipurposeDIMETHICONECosmetique Active Productiond19f482c-bec7-45aa-b22f-fe91a3dc717d2026-09-10WarningsExact identifier
unii: 92RU3N3Y1O
Pepto Gas plus BloatingSIMETHICONEThe Procter & Gamble Manufacturing Company3d80a5bb-0ed0-769a-e063-6394a90ac50c2026-09-10WarningsExact identifier
unii: 92RU3N3Y1O
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
MedlineDIMETHICONEMedline Industries, LP5afb3595-f014-153e-e063-6294a90ad34b2026-09-08WarningsExact identifier
unii: 92RU3N3Y1O
MedlineDIMETHICONEMedline Industries, LP5afb59b4-491c-45bb-e063-6294a90a0ae62026-09-08WarningsExact identifier
unii: 92RU3N3Y1O
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
unii: PDC6A3C0OX
Gas Relief Mint FlavorSIMETHICONERaritan Pharmaceuticals Inc329388cb-3ca1-4ecb-8b50-b1f9e00525592026-09-08WarningsExact identifier
unii: 92RU3N3Y1O
SimethiconeSIMETHICONESOFTGEL HEALTHCARE PRIVATE LIMITED3205339a-3914-4e25-e063-6394a90a07cd2026-09-04WarningsExact identifier
unii: 92RU3N3Y1O
Simethicone 125MG Gas ReliefSIMETHICONE 125 MGOne2Zee Limited Liability Company0df348bf-5a07-4f36-ae70-ca2961a9ce7e2026-09-04WarningsExact identifier
unii: 92RU3N3Y1O
anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONERite Aid Corporation8e954f86-bc15-45e2-9274-ca5d8a7c96872026-09-04WarningsExact identifier
unii: 92RU3N3Y1O
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
unii: PDC6A3C0OX
Infants Gas Relief DropsSIMETHICONEDOLGENCORP INC6b132ac0-e8eb-4199-85ad-5976558ee9c82026-09-03WarningsExact identifier
unii: 92RU3N3Y1O
DG HEALTH Liquid Antacid plus Anti GasCALCIUM CARBONATE, MAGNESIUM HYDROXIDE AND SIMETHICONEDOLGENCORP, LLC8ecb4418-e647-49b5-b418-1c63bb3e5a3c2026-09-03WarningsExact identifier
unii: 92RU3N3Y1O
Simethicone DropsSIMETHICONE DROPSEverpharm LLC5a6d2c1f-4067-969f-e063-6394a90aa83f2026-09-02WarningsExact identifier
unii: 92RU3N3Y1O
TEENY TUMMY Gas Relief DropsSIMETHICONEAkron Pharmadcdd0daf-5ef0-4cb2-872d-89ed6e9f6d602026-09-01WarningsExact identifier
unii: 92RU3N3Y1O
Aloetouch Protect Fragrance FreeDIMETHICONEMedline Industries, LP81f0071b-2bf3-455b-9e5d-8f3ca20adcdf2026-09-01WarningsExact identifier
unii: 92RU3N3Y1O
SILICONE SCARDIMETHICONEHaikou Flash Purchase Star Cross-Border Trade Co., Ltd.5a7727d1-09d1-3cb3-e063-6294a90a1bc52026-09-01WarningsExact identifier
unii: 92RU3N3Y1O
Kroger Extra StrengthSIMETHICONE ANTIGASKROGER COMPANY67ddce93-4d68-4280-bf8b-337b91ab8c8f2026-09-01WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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