FDA.reportPublic FDA data

NDC 53208-445-01 - Sooryehan Pure-Whitening Essential Starter

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
53208-445
Requested NDC
53208-445-01
Package NDCs from labels
53208-445-01, 53208-445-02
Manufacturer
LG Household and Healthcare, Inc.
Effective date
2010-05-13
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.2010-05-13HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53208-445-022019-10-21C16284748780-1956f9ecf-c885-621f-e053-dbdaa90a74adDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53208-445-01Sooryehan Pure-Whitening Essential Starter160 mL in 1 CONTAINERCREAM1601
53208-445-02Sooryehan Pure-Whitening Essential Starter1 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53208-445SOORYEHAN PURE-WHITENING ESSENTIAL STARTER (ARBUTIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1Legacy NDC, 2 package rows20100514_9d81c118-6c63-4a4b-995d-2dee6deba036.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARBUTINACTIVE INGREDIENTC5INA23HXFSOORYEHAN PURE-WHITENING ESSENTIAL STARTER (ARBUTIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
ARBUTINACTIVE MOIETYC5INA23HXFSOORYEHAN PURE-WHITENING ESSENTIAL STARTER (ARBUTIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SSOORYEHAN PURE-WHITENING ESSENTIAL STARTER (ARBUTIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C40SOORYEHAN PURE-WHITENING ESSENTIAL STARTER (ARBUTIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MSOORYEHAN PURE-WHITENING ESSENTIAL STARTER (ARBUTIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8SOORYEHAN PURE-WHITENING ESSENTIAL STARTER (ARBUTIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSOORYEHAN PURE-WHITENING ESSENTIAL STARTER (ARBUTIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKSOORYEHAN PURE-WHITENING ESSENTIAL STARTER (ARBUTIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSOORYEHAN PURE-WHITENING ESSENTIAL STARTER (ARBUTIN) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1

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 5 of 23 · 452 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermatool HemorrhoidalGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLPapalo Group LLC4bc06f41-7733-ebd0-e063-6294a90af7a82026-02-26WarningsExact identifier
unii: PDC6A3C0OX
WowDay Hemorrhoid and Fissure CreamHEMORRHOID AND FISSURE CREAMWowDay LLC47ba86ad-240a-e733-e063-6394a90a24e32026-02-12WarningsExact identifier
unii: PDC6A3C0OX
Viva Hydration BoostGLYCERINNomax Inc174193b2-65eb-b5fd-e063-6394a90a9cd02026-02-10WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Inc376e0289-28e9-e87f-e063-6294a90a3b042026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Inc10c3e31d-779d-8ff6-e063-6294a90acd392026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Inc9e96976b-2990-79e0-e053-2995a90a0f292026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Incd81c1a4f-87b0-ee8c-e053-2995a90af9e52026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Incf452a2c4-c869-7bf5-e053-2995a90ac1a02026-01-30WarningsExact identifier
unii: PDC6A3C0OX
Regener-Eyes Ophthalmic Solution LITE XLGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, L.L.C.47ab9609-4291-30b2-e063-6394a90a421e2026-01-29WarningsExact identifier
unii: PDC6A3C0OX
Regener-Eyes Ophthalmic Solution PROFESSIONAL STRENGTH XLGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, L.L.C.48d6dc98-66e8-b499-e063-6394a90ae9352026-01-29WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Inc86c14327-ffc7-806e-e053-2991aa0aaf922026-01-29WarningsExact identifier
unii: PDC6A3C0OX
Regener-Eyes Ophthalmic Solution PROFESSIONALGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC49771efa-6682-51d0-e063-6294a90a18a52026-01-28WarningsExact identifier
unii: PDC6A3C0OX
Regener-Eyes Ophthalmic Solution LITEGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC497763ee-dc70-bb48-e063-6294a90afb3d2026-01-28WarningsExact identifier
unii: PDC6A3C0OX
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Lemon GlycerinGLYCERINJianerkang Medical Co., Ltdedee14da-13d8-4bc2-9c37-cfc353763d112026-01-16WarningsExact identifier
unii: PDC6A3C0OX
Hemorrhoidal CreamHEMORRHOIDAL CREAMWalgreens1ac2b2ae-c090-483b-ad2c-1374552add4a2026-01-15WarningsExact identifier
unii: PDC6A3C0OX
Walgreens Adult Glycerin LaxativeGLYCERIN SUPPOSITORYWalgreensf19c6cca-e763-4c38-a546-855f027d20c52026-01-15WarningsExact identifier
unii: PDC6A3C0OX
Walgreens Adult Glycerin LaxativeGLYCERIN SUPPOSITORYWalgreens1a00ff43-ba79-4339-a547-f9757872958b2026-01-15WarningsExact identifier
unii: PDC6A3C0OX
Hemorrhoidal CreamHEMORRHOIDAL CREAMWalgreens4276ddad-2363-462a-bb97-574f946ec3f02026-01-15WarningsExact identifier
unii: PDC6A3C0OX
Hemorrhoid and FissureGLYCERIN 6%,LIDOCAINE 4%,ECTOIN 0.12%FlexiGo Inc48697377-61c0-1b0a-e063-6294a90a32932026-01-15WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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