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 37 of 55 · 1,091 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mentholatum Medicated Lip Balm OriginalDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Companyf84cc3a4-cc9f-4a38-8b7d-cf8d6cd39df12024-12-17WarningsExact identifier
unii: 92RU3N3Y1O
Mentholatum Natural Ice Sport SPF 30AVOBENZONE, DIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company57c35631-42d3-4c6c-bcbb-e2de92b45b132024-12-17WarningsExact identifier
unii: 92RU3N3Y1O
RECTICARELIDOCAINE AND GLYCERINFerndale Laboratories, Inc.2b94136a-4975-2925-e054-00144ff88e882024-12-17WarningsExact identifier
unii: PDC6A3C0OX
Softlips Cherry Cordial, Maple Butter, Frosted BerryDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Companybab8447b-58b8-4160-a91e-05f9fd09ed1d2024-12-17WarningsExact identifier
unii: 92RU3N3Y1O
Leader Gas reliefSIMETHICONECARDINAL HEALTH 110, LLC. DBA LEADER0163d372-222e-4a8d-a5cb-5a7af9a7068c2024-12-17WarningsExact identifier
unii: 92RU3N3Y1O
Secura Dimethicone ProtectantDIMETHICONESmith & Nephew Medical Ltd83f92ac9-4114-4192-926d-be2854a841062024-12-16WarningsExact identifier
unii: 92RU3N3Y1O
Maximum Strength Gas Relief Softgel-60ctSIMETHICONEHEBf65e362a-2f90-428a-b885-eefdad8cae1e2024-12-16WarningsExact identifier
unii: 92RU3N3Y1O
Maximum Strength Gas ReliefSIMETHICONEChain Drug Marketing Association, Inc.e8b2c528-121d-519a-e053-2a95a90a41192024-12-16WarningsExact identifier
unii: 92RU3N3Y1O
Copperlife FootDIMETHICONE 1%Tommie Copper, Inc.cb825d2c-6333-3c1f-e053-2995a90a78f32024-12-15WarningsExact identifier
unii: 92RU3N3Y1O
Tommie Copper FootDIMETHICONE 1%Tommie Copper, Inc.ca3d3374-a3d4-69e5-e053-2995a90a3ece2024-12-15WarningsExact identifier
unii: 92RU3N3Y1O
Gas Relief Ultra StrengthDIMETHICONETOPCO ASSOCIATES LLCb9a4c876-722b-4d6c-807f-005ccf5df3202024-12-14WarningsExact identifier
unii: 92RU3N3Y1O
Gas Relief Extra StrengthDIMETHICONETOPCO ASSOCIATES LLCbb1c54d4-3a36-4b77-8659-2e92845d2f0e2024-12-14WarningsExact identifier
unii: 92RU3N3Y1O
Mentholatum Natural Ice CherryDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company33f43f14-8e0b-41b1-8ad0-5723d2a7bf192024-12-13WarningsExact identifier
unii: 92RU3N3Y1O
Household DetoxALLIUM SATIVUM, ALUMINA, ANTIPYRINUM, BENZINUM, BISPHENOL A, CARBOLICUM ACIDUM, CARBONEUM SULPHURATUM, DIETHYLSTILBESTROL, DIOXIN, FOLLICULINUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PARAFFINUM, PETROLEUM, PHENACETINUM, PTELEA TRIFOLIATA, SODIUM CARBOXYMETHYL CELLULOSE, TEFLONDeseret Biologicals, Inc.7f79058a-c35a-429a-be3c-4cff1d6570872024-12-13WarningsExact identifier
unii: A2I8C7HI9T
Foster and Thrive Extra Strength Gas Relief CherrySIMETHICONEStrategic Sourcing Services LLCe47374c8-05c1-4874-871b-e83d9b305bd32024-12-13WarningsExact identifier
unii: 92RU3N3Y1O
Foster and Thrive infants Gas reliefSIMETHICONEStrategic Sourcing Services LLC824c9dff-0a26-4710-a25b-39df631d6fa62024-12-13WarningsExact identifier
unii: 92RU3N3Y1O
Gas-X Extra StrengthSIMETHICONEHaleon US Holdings LLC7ce312ca-542b-4bc0-97b5-f65279e1e84c2024-12-13WarningsExact identifier
unii: 92RU3N3Y1O
Mylanta Maximum Strength Classic FlavorANTACID AND ANTI GAS ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.56853b20-a2aa-4b19-a428-3dde232114c62024-12-11WarningsExact identifier
unii: 92RU3N3Y1O
Mylanta New Tonight Soothing Honey ChamomileCALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.123f3005-a0a0-4970-94f1-f6d04741078b2024-12-11WarningsExact identifier
unii: 92RU3N3Y1O
GERI-LANTA MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONENuCare Pharmaceuticals, Inc.fd160cfd-9ad4-81c7-e053-6394a90a33f62024-12-11WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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