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 28 of 55 · 1,091 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold Sore Fast-Acting Pain ReliefGLYCERIN AND LIDOCAINEBlistex Inc.c7511322-dd6c-441c-bf7d-ad4f0c14956a2025-07-22WarningsExact identifier
unii: PDC6A3C0OX
Cureforte Breath ResetMOUTH SPRAYSTEEL CITY HEALTH PRIVATE LIMITED38ddf1a7-29ab-cb8d-e063-6294a90ad34c2025-07-21WarningsExact identifier
unii: PDC6A3C0OX
GoodSense Hemorrhoidal Pain ReliefGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLPerrigo Direct, Inc2e5f699d-45e8-6451-e063-6394a90a8ad82025-07-20WarningsExact identifier
unii: PDC6A3C0OX
Medicated Peppermint Lip BalmDIMETHICONE, UNSPECIFIED, OCTINOXATE, AND OCTISALATEBlistex Inc5d48a6fa-ddce-47c3-9b09-1f3abb6950172025-07-18WarningsExact identifier
unii: 92RU3N3Y1O
Gas Relief Ultra StrengthSIMETHICONERugby Laboratories, Inc.24731f4b-ca2b-483f-beed-dfc8104f81332025-07-18WarningsExact identifier
unii: 92RU3N3Y1O
Aveeno DAILY MOISTURIZINGDIMETHICONEKenvue Brands LLC54a13b85-32b5-439d-a27a-8fba2cf442512025-07-16WarningsExact identifier
unii: 92RU3N3Y1O
SilkTearsGLYCERIN OPHTHALMIC SOLUTIONSilkTears3866e2c1-051b-0b01-e063-6394a90af5cf2025-07-16WarningsExact identifier
unii: PDC6A3C0OX
Aluminum Hydroxide, Magnesium Hydroxide, and DimethiconeALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND DIMETHICONEAmerican Health Packaging23539e7e-a723-460f-892f-dac5bbbb9b162025-07-15WarningsExact identifier
unii: 92RU3N3Y1O
Gas-X Total Relief Maximum StrengthCALCIUM CARBONATE, SIMETHICONEHaleon US Holdings LLCedb0f11a-bdb7-484d-9257-09ff47b0fca42025-07-15WarningsExact identifier
unii: 92RU3N3Y1O
ProCure Moisture Barrier1% DIMETHICONE, 12% ZINC OXIDETwin Med LLC3988c83b-d4eb-1f09-e063-6394a90a45ad2025-07-14WarningsExact identifier
unii: 92RU3N3Y1O
Nikzon HemorrhoidalGLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDEGenomma Lab USA8f9a9939-2c99-489f-b597-9a51ec2684f92025-07-14WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
REGULAR STRENGTH ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEWALGREEN COMPANY7cd9234e-d1cc-4cce-e053-2991aa0a457e2025-07-09WarningsExact identifier
unii: 92RU3N3Y1O
Maximum Strength Hemorrhoidal Cream with AloeGLYCERIN, PHENYLEPHINE HCI, PRAMOXINE HCI, PETROLATUMChain Drug Marketing Association396ea654-8be1-591a-e063-6294a90a11e22025-07-08WarningsExact identifier
unii: PDC6A3C0OX
Aluminum Hydroxide, Magnesium Hydroxide, and SimethiconeALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONEMajor Pharmaceuticals1bc90fa7-fcce-4a9b-862f-f30ab602ecab2025-07-07WarningsExact identifier
unii: 92RU3N3Y1O
Curist Gas ReliefSIMETHICONELittle Pharma. Inc.3948c0e5-4ee7-5443-e063-6294a90ad6ae2025-07-06WarningsExact identifier
unii: 92RU3N3Y1O
Hemorrhoidal CreamGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc38cf4e43-280b-eb96-e063-6294a90a59492025-07-02WarningsExact identifier
unii: PDC6A3C0OX
SEFUDUN FUNGAL NAIL PATCHESGLYCERINShenzhen Shandian Jingling Technology Co., Ltd.38db97d6-27c8-da99-e063-6294a90aac662025-07-01WarningsExact identifier
unii: PDC6A3C0OX
Exemax CreamDIMETHICONE, ALLANTOINPureTek Corporation38e79055-df84-d314-e063-6394a90ac95f2025-07-01WarningsExact identifier
unii: 92RU3N3Y1O
Aluminum Hydroxide, Magnesium Hydroxide and SimethiconeALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONERising Pharma Holdings, Inc.982129d4-3cbf-4793-a861-d6c8f34bedc32025-07-01WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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