FDA.reportPublic FDA data

NDC 53208-444-01 - Sooryehan Pure Whitening Spot Treatment

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
53208-444
Requested NDC
53208-444-01
Package NDCs from labels
53208-444-01, 53208-444-02
Manufacturer
LG Household and Healthcare, Inc.
Effective date
2010-05-03
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.2010-05-03HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53208-444-022019-10-21C16284748780-1956f9ecf-c19e-621f-e053-dbdaa90a74adDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53208-444-01Sooryehan Pure Whitening Spot Treatment25 mL in 1 CONTAINERCREAM252
53208-444-02Sooryehan Pure Whitening Spot Treatment1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53208-444SOORYEHAN PURE WHITENING SPOT TREATMENT (POLYDATIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]2Legacy NDC, 2 package rows20100504_d878325d-65c6-4c87-99d4-2dab806b205e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POLYDATINACTIVE INGREDIENTXM261C37CQSOORYEHAN PURE WHITENING SPOT TREATMENT (POLYDATIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]2
POLYDATINACTIVE MOIETYXM261C37CQSOORYEHAN PURE WHITENING SPOT TREATMENT (POLYDATIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]2
CAPRYLIC/CAPRIC MONO/DIGLYCERIDESINACTIVE INGREDIENTU72Q2I8C85SOORYEHAN PURE WHITENING SPOT TREATMENT (POLYDATIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SSOORYEHAN PURE WHITENING SPOT TREATMENT (POLYDATIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]2
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RSOORYEHAN PURE WHITENING SPOT TREATMENT (POLYDATIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OSOORYEHAN PURE WHITENING SPOT TREATMENT (POLYDATIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]2
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C40SOORYEHAN PURE WHITENING SPOT TREATMENT (POLYDATIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]2
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MSOORYEHAN PURE WHITENING SPOT TREATMENT (POLYDATIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8SOORYEHAN PURE WHITENING SPOT TREATMENT (POLYDATIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSOORYEHAN PURE WHITENING SPOT TREATMENT (POLYDATIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4SOORYEHAN PURE WHITENING SPOT TREATMENT (POLYDATIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]2
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZSOORYEHAN PURE WHITENING SPOT TREATMENT (POLYDATIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSOORYEHAN PURE WHITENING SPOT TREATMENT (POLYDATIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKSOORYEHAN PURE WHITENING SPOT TREATMENT (POLYDATIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RSOORYEHAN PURE WHITENING SPOT TREATMENT (POLYDATIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]2

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 4 of 155 · 3,095 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mylanta Fall Harvest Collection Pumpkin SpiceCALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.5a60a221-5b37-806e-e063-6394a90a5ccc2026-08-15WarningsExact identifier
unii: 92RU3N3Y1O
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
BM BM164 DROPSARUM TRYPH, CAUSTICUM, BALSAMUM PERU, HELONIAS DIO, ACID PHOS, GLYCERINUM, EQUISETUMBM Private Limited5902770f-eb01-d099-e063-6394a90ad3eb2026-08-14WarningsExact identifier
unii: PDC6A3C0OX
CVS PHARMACY Extra Strength Gas ReliefSIMETHICONE ANTIGASCVSb0fc2f24-cd63-4bb2-b9bb-a73449bcc1692026-08-13WarningsExact identifier
unii: 92RU3N3Y1O
CVS PHARMACY Extra StrengthSIMETHICONECVS98db6216-897c-4cf6-a4b7-b913ae3a24962026-08-13WarningsExact identifier
unii: 92RU3N3Y1O
CVS PHARMACY Gas reliefSIMETHICONECVSc2a3a978-c957-4453-88b3-53f4e80a24652026-08-13WarningsExact identifier
unii: 92RU3N3Y1O
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
unii: 15FIX9V2JP
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
unii: 15FIX9V2JP
WinCo FOODS Extra Strength Gas ReliefSIMETHICONEWINCO FOODS, LLCe2caf17a-a807-47f6-ab85-8e15a4679db42026-08-07WarningsExact identifier
unii: 92RU3N3Y1O
Extra Strength Gas ReliefSIMETHICONEShield Pharmaceuticals Corp55952af9-c3c1-452f-82c8-06f01dc4f0af2026-08-07WarningsExact identifier
unii: 92RU3N3Y1O
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AMAZON EXTRA STRENGTHSIMETHICONEAMAZON.COM SERVICES LLC705489ce-ac7c-44a8-8298-ead19824582e2026-08-06WarningsExact identifier
unii: 92RU3N3Y1O
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
Gencare-Gas ReliefSIMETHICONE 180 MGPIONEER LIFE SCIENCES, LLCb7f2d5db-c1b7-4c01-8ee6-017e4b9f14252026-08-04WarningsExact identifier
unii: 92RU3N3Y1O
CVS GlycerinGLYCERIN SUPPOISITORYCVS Pharmacy, Incca6d13db-60e8-4fcc-b7b3-3eb280b8c4352026-08-04WarningsExact identifier
unii: PDC6A3C0OX
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
SimethiconeSIMETHICONEAphena Pharma Solutions - Tennessee, LLCda0cc98e-1692-405a-ab81-420d6f9df6de2026-07-31WarningsExact identifier
unii: 92RU3N3Y1O
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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