Home NDC 50865-025-09 Soft and Silky Antiseptic
Product NDC 50865-025
Requested package NDC 50865-025-09
11-digit product format 508650025
Labeler code 50865
Product ID 50865-025_298df384-7077-6a74-e063-6394a90aecb5
Type HUMAN OTC DRUG
Nonproprietary name Antiseptic Lotion Soap
Dosage form SOLUTION
Route TOPICAL
Labeler Kutol Products Company, Inc.
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-11-04
Substance CHLOROXYLENOL
Active strength 3.82 g/100mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 50865-025 50865-025-09 I Inactivated by FDA excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 50865-025 50865-025-09 I Inactivated by FDA excluded / ndc_excluded.zip 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 50865-025 50865-025-09 I Inactivated by FDA excluded / ndc_excluded.zip bd6a592717d7…303034d00443…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Soft and Silky Antiseptic
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLOROXYLENOL 3.82 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0F32U78V2Q Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50865-025-03 Soft and Silky Antiseptic 208175 mL in 1 DRUM SOLUTION 208175 6 50865-025-07 Soft and Silky Antiseptic 3785 mL in 1 BOTTLE, PLASTIC SOLUTION 3785 6 50865-025-09 Soft and Silky Antiseptic 3785 mL in 1 BOTTLE, PLASTIC SOLUTION 3785 6 50865-025-12 Soft and Silky Antiseptic 1200 mL in 1 BAG SOLUTION 1200 6 50865-025-18 Soft and Silky Antiseptic 500 mL in 1 BAG SOLUTION 500 6 50865-025-65 Soft and Silky Antiseptic 800 mL in 1 BAG SOLUTION 800 6 50865-025-80 Soft and Silky Antiseptic 800 mL in 1 BOTTLE, PLASTIC SOLUTION 800 6 50865-025-82 Soft and Silky Antiseptic 800 mL in 1 BOTTLE, PLASTIC SOLUTION 800 6 50865-025-93 Soft and Silky Antiseptic 1200 mL in 1 BOTTLE, PLASTIC SOLUTION 1200 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CHLOROXYLENOL ACTIVE INGREDIENT 0F32U78V2Q SOFT AND SILKY ANTISEPTIC (ANTISEPTIC LOTION SOAP) SOLUTION [KUTOL PRODUCTS COMPANY, INC.] 1 CHLOROXYLENOL ACTIVE MOIETY 0F32U78V2Q SOFT AND SILKY ANTISEPTIC (ANTISEPTIC LOTION SOAP) SOLUTION [KUTOL PRODUCTS COMPANY, INC.] 1 COCO DIISOPROPANOLAMIDE INACTIVE INGREDIENT S485AM948Q SOFT AND SILKY ANTISEPTIC (ANTISEPTIC LOTION SOAP) SOLUTION [KUTOL PRODUCTS COMPANY, INC.] 1 COCONUT ACID INACTIVE INGREDIENT 40U37V505D SOFT AND SILKY ANTISEPTIC (ANTISEPTIC LOTION SOAP) SOLUTION [KUTOL PRODUCTS COMPANY, INC.] 1 EDETATE SODIUM INACTIVE INGREDIENT MP1J8420LU SOFT AND SILKY ANTISEPTIC (ANTISEPTIC LOTION SOAP) SOLUTION [KUTOL PRODUCTS COMPANY, INC.] 1 IODOPROPYNYL BUTYLCARBAMATE INACTIVE INGREDIENT 603P14DHEB SOFT AND SILKY ANTISEPTIC (ANTISEPTIC LOTION SOAP) SOLUTION [KUTOL PRODUCTS COMPANY, INC.] 1 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T SOFT AND SILKY ANTISEPTIC (ANTISEPTIC LOTION SOAP) SOLUTION [KUTOL PRODUCTS COMPANY, INC.] 1 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T SOFT AND SILKY ANTISEPTIC (ANTISEPTIC LOTION SOAP) SOLUTION [KUTOL PRODUCTS COMPANY, INC.] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X SOFT AND SILKY ANTISEPTIC (ANTISEPTIC LOTION SOAP) SOLUTION [KUTOL PRODUCTS COMPANY, INC.] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J SOFT AND SILKY ANTISEPTIC (ANTISEPTIC LOTION SOAP) SOLUTION [KUTOL PRODUCTS COMPANY, INC.] 1 TALL OIL INACTIVE INGREDIENT 1GX6Z36A79 SOFT AND SILKY ANTISEPTIC (ANTISEPTIC LOTION SOAP) SOLUTION [KUTOL PRODUCTS COMPANY, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R SOFT AND SILKY ANTISEPTIC (ANTISEPTIC LOTION SOAP) SOLUTION [KUTOL PRODUCTS COMPANY, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50865-025 SOFT AND SILKY ANTISEPTIC (ANTISEPTIC LOTION SOAP) SOLUTION [KUTOL PRODUCTS COMPANY, INC.] 6 Current NDC, Legacy NDC, 9 package rows 20241220_09d96b8d-be13-4295-8110-98dd82a454fa.zip
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 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50865-025-09 50865002509 3785 mL in 1 BOTTLE, PLASTIC (50865-025-09) 3785 ml 2013-11-04 0000-00-00 No No Current