FDA.reportPublic FDA data

Golden Medicated

Product NDC
50865-060
11-digit product format
508650060
Labeler code
50865
Product ID
50865-060_298f23a0-1c3b-6946-e063-6394a90aed9a
Type
HUMAN OTC DRUG
Nonproprietary name
Medicated Lotion Soap
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Kutol Products Company
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-03-11
Substance
CHLOROXYLENOL
Active strength
.3 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Golden Medicated
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLOROXYLENOL.3 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0F32U78V2Q
Rxcui413261

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50865-060-092023-08-28C16284748780-1ba0f9c33-0e29-a910-e053-dadaa90a0b85Kutol F060
50865-060-272023-08-28C16284748780-1ba0f9c33-0e29-a910-e053-dadaa90a0b85Kutol F060
50865-060-092021-01-29C16284748780-1ba0f9c33-0e29-a910-e053-dadaa90a0b85Kutol F060
50865-060-272021-01-29C16284748780-1ba0f9c33-0e29-a910-e053-dadaa90a0b85Kutol F060

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50865-060-09Golden Medicated3785 mL in 1 BOTTLE, PLASTICSOLUTION37854
50865-060-27Golden Medicated1000 mL in 1 BAGSOLUTION10004

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLOROXYLENOLACTIVE INGREDIENT0F32U78V2QGOLDEN MEDICATED (MEDICATED LOTION SOAP) SOLUTION [KUTOL PRODUCTS COMPANY, INC.]1
CHLOROXYLENOLACTIVE MOIETY0F32U78V2QGOLDEN MEDICATED (MEDICATED LOTION SOAP) SOLUTION [KUTOL PRODUCTS COMPANY, INC.]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0GOLDEN MEDICATED (MEDICATED LOTION SOAP) SOLUTION [KUTOL PRODUCTS COMPANY, INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XGOLDEN MEDICATED (MEDICATED LOTION SOAP) SOLUTION [KUTOL PRODUCTS COMPANY, INC.]1
COCO DIISOPROPANOLAMIDEINACTIVE INGREDIENTS485AM948QGOLDEN MEDICATED (MEDICATED LOTION SOAP) SOLUTION [KUTOL PRODUCTS COMPANY, INC.]1
COCONUT ACIDINACTIVE INGREDIENT40U37V505DGOLDEN MEDICATED (MEDICATED LOTION SOAP) SOLUTION [KUTOL PRODUCTS COMPANY, INC.]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LGOLDEN MEDICATED (MEDICATED LOTION SOAP) SOLUTION [KUTOL PRODUCTS COMPANY, INC.]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUGOLDEN MEDICATED (MEDICATED LOTION SOAP) SOLUTION [KUTOL PRODUCTS COMPANY, INC.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MGOLDEN MEDICATED (MEDICATED LOTION SOAP) SOLUTION [KUTOL PRODUCTS COMPANY, INC.]1
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEBGOLDEN MEDICATED (MEDICATED LOTION SOAP) SOLUTION [KUTOL PRODUCTS COMPANY, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TGOLDEN MEDICATED (MEDICATED LOTION SOAP) SOLUTION [KUTOL PRODUCTS COMPANY, INC.]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TGOLDEN MEDICATED (MEDICATED LOTION SOAP) SOLUTION [KUTOL PRODUCTS COMPANY, INC.]1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0GOLDEN MEDICATED (MEDICATED LOTION SOAP) SOLUTION [KUTOL PRODUCTS COMPANY, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JGOLDEN MEDICATED (MEDICATED LOTION SOAP) SOLUTION [KUTOL PRODUCTS COMPANY, INC.]1
SODIUM SULFATEINACTIVE INGREDIENT0YPR65R21JGOLDEN MEDICATED (MEDICATED LOTION SOAP) SOLUTION [KUTOL PRODUCTS COMPANY, INC.]1
TALL OIL ACIDINACTIVE INGREDIENTH9HR63474MGOLDEN MEDICATED (MEDICATED LOTION SOAP) SOLUTION [KUTOL PRODUCTS COMPANY, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RGOLDEN MEDICATED (MEDICATED LOTION SOAP) SOLUTION [KUTOL PRODUCTS COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50865-060GOLDEN MEDICATED (MEDICATED LOTION SOAP) SOLUTION [KUTOL PRODUCTS COMPANY]4Current NDC, Legacy NDC, 2 package rows20241220_e6b1f1e4-edf7-4ae9-a16a-5b5a81c94d6d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
413261chloroxylenol 0.3 % Medicated Liquid SoapPSNe6b1f1e4-edf7-4ae9-a16a-5b5a81c94d6d4
413261chloroxylenol 3 MG/ML Medicated Liquid SoapSCDe6b1f1e4-edf7-4ae9-a16a-5b5a81c94d6d4
413261chloroxylenol 0.3 % Medicated Liquid SoapSYe6b1f1e4-edf7-4ae9-a16a-5b5a81c94d6d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50865-060-09508650060093785 mL in 1 BOTTLE, PLASTIC (50865-060-09) 3785 ml2014-03-11NoNoCurrent
50865-060-27508650060271000 mL in 1 BAG (50865-060-27) 1000 ml2014-03-11NoNoCurrent