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 1 of 157 · 3,130 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
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
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

Reported adverse events (FAERS/openFDA)#

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