FDA.reportPublic FDA data

1012 Antimicrobial

Product NDC
62257-012
11-digit product format
622570012
Labeler code
62257
Product ID
62257-012_518d0d57-180d-1f5c-e063-6394a90a19fa
Type
HUMAN OTC DRUG
Nonproprietary name
CHLOROXYLENOL
Dosage form
SOAP
Route
TOPICAL
Labeler
ABC Compounding Co., Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-05-01
Substance
CHLOROXYLENOL
Active strength
3 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
1012 Antimicrobial
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLOROXYLENOL3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0F32U78V2Q
Rxcui413261

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62257-012-061012 Antimicrobial800 mL in 1 BAGSOAP8007
62257-012-061012 Antimicrobial1 in 1 BOXSOAP17
62257-012-101012 Antimicrobial1000 mL in 1 CARTRIDGESOAP10007
62257-012-111012 Antimicrobial1000 mL in 1 BOTTLE, PLASTICSOAP10007
62257-012-141012 Antimicrobial3785 mL in 1 BOTTLE, PLASTICSOAP37857
62257-012-171012 Antimicrobial532 mL in 1 BOTTLE, PLASTICSOAP5327
62257-012-551012 Antimicrobial208200 mL in 1 DRUMSOAP2082007

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLOROXYLENOLACTIVE INGREDIENT0F32U78V2Q1012 ANTIMICROBIAL (CHLOROXYLENOL) SOAP [ABC COMPOUNDING CO., INC.]2
CHLOROXYLENOLACTIVE MOIETY0F32U78V2Q1012 ANTIMICROBIAL (CHLOROXYLENOL) SOAP [ABC COMPOUNDING CO., INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1012 ANTIMICROBIAL (CHLOROXYLENOL) SOAP [ABC COMPOUNDING CO., INC.]2
COCO MONOISOPROPANOLAMIDEINACTIVE INGREDIENT21X4Y0VTB11012 ANTIMICROBIAL (CHLOROXYLENOL) SOAP [ABC COMPOUNDING CO., INC.]2
DECYL GLUCOSIDEINACTIVE INGREDIENTZ17H97EA6Y1012 ANTIMICROBIAL (CHLOROXYLENOL) SOAP [ABC COMPOUNDING CO., INC.]2
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1M1012 ANTIMICROBIAL (CHLOROXYLENOL) SOAP [ABC COMPOUNDING CO., INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31012 ANTIMICROBIAL (CHLOROXYLENOL) SOAP [ABC COMPOUNDING CO., INC.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X1012 ANTIMICROBIAL (CHLOROXYLENOL) SOAP [ABC COMPOUNDING CO., INC.]2
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP01012 ANTIMICROBIAL (CHLOROXYLENOL) SOAP [ABC COMPOUNDING CO., INC.]2
WATERINACTIVE INGREDIENT059QF0KO0R1012 ANTIMICROBIAL (CHLOROXYLENOL) SOAP [ABC COMPOUNDING CO., INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62257-0121012 ANTIMICROBIAL (CHLOROXYLENOL) SOAP [ABC COMPOUNDING CO., INC.]5Current NDC, Legacy NDC, 7 package rows20250424_4dc6367c-5347-4a5c-b0d0-e93a4277a849.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
413261chloroxylenol 0.3 % Medicated Liquid SoapPSN4dc6367c-5347-4a5c-b0d0-e93a4277a8497
413261chloroxylenol 3 MG/ML Medicated Liquid SoapSCD4dc6367c-5347-4a5c-b0d0-e93a4277a8497
413261chloroxylenol 0.3 % Medicated Liquid SoapSY4dc6367c-5347-4a5c-b0d0-e93a4277a8497

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62257-012-06622570012061 BAG in 1 BOX (62257-012-06) > 800 mL in 1 BAG1 bag2013-05-010000-00-00NoNoCurrent
62257-012-10622570012101000 mL in 1 CARTRIDGE (62257-012-10) 1000 ml2013-05-010000-00-00NoNoCurrent
62257-012-11622570012111000 mL in 1 BOTTLE, PLASTIC (62257-012-11) 1000 ml2013-05-010000-00-00NoNoCurrent
62257-012-14622570012143785 mL in 1 BOTTLE, PLASTIC (62257-012-14) 3785 ml2013-05-010000-00-00NoNoCurrent
62257-012-1762257001217532 mL in 1 BOTTLE, PLASTIC (62257-012-17) 532 ml2013-05-010000-00-00NoNoCurrent
62257-012-5562257001255208200 mL in 1 DRUM (62257-012-55) 208200 ml2013-05-010000-00-00NoNoCurrent