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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage62257-01262257-012-06DDiscontinued by firm2026-10-16
excluded packagepackage62257-01262257-012-10DDiscontinued by firm2026-10-16
excluded packagepackage62257-01262257-012-11DDiscontinued by firm2026-10-16
excluded packagepackage62257-01262257-012-17DDiscontinued by firm2026-10-16
excluded packagepackage62257-01262257-012-55DDiscontinued by firm2026-10-16

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 · 5 matching rows.

View current auxiliary records. · View the auxiliary file history.

Package NDC table
Package NDC
62257-012-10
62257-012-17
62257-012-11
62257-012-06
62257-012-55

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
1012 Antimicrobial
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLOROXYLENOL3 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0F32U78V2QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
413261Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4dc6367c-5347-4a5c-b0d0-e93a4277a849Available on FDA.report

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

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 4 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gentian VioletGENTIAN VIOLETVitamex USA, Corp21742061-fc0b-f750-e063-6394a90a75082026-08-26WarningsExact identifier
application number: M003
MercurochromeBENZALKONIUM CHLORIDEVitamex USA, Corp21652b11-715d-0c54-e063-6294a90a88552026-08-26WarningsExact identifier
application number: M003
Scentsational Square Hand SanitizerHAND SANITIZERRaining Rose, Inc.59f9bacf-80dc-3468-e063-6294a90a0ae12026-08-26WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59fa27b4-dfd4-720b-e063-6394a90af6592026-08-26WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59fb22d6-f6a4-42cd-e063-6394a90a859a2026-08-26WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59fbb054-461e-aa6e-e063-6394a90a470c2026-08-26WarningsExact identifier
application number: M003
Curad Alcohol Sterile, ThickISOPROPYL ALCOHOLMedline Industries, LPb769898e-a73f-4323-af15-bee8dbe455b62026-08-25WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEYour Military Exchangesa71734c6-6b92-4d3d-84d1-a07f592fa8282026-08-25Warnings, Adverse reactionsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59e742a6-61f9-59f7-e063-6394a90a87382026-08-25WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59e7dfb1-49b5-d2be-e063-6394a90a04d82026-08-25WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59d3c369-86aa-8ebd-e063-6394a90aa8062026-08-24WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59d7fc3c-3a93-153d-e063-6394a90ac6472026-08-24WarningsExact identifier
application number: M003
Be Smart Get Prepared Hand SanitizerALCOHOLTotal Resources International, Inc23d0dc62-28d6-4d1f-a7d5-4b14f5c9fb1e2026-08-24WarningsExact identifier
application number: M003
ClaravieBENZALKONIUM CHLORIDEGentell LLC59887af3-9b22-9664-e063-6294a90a57c62026-08-21WarningsExact identifier
application number: M003
hand sanitizer- light blue 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598a96f0-33fe-40aa-e063-6394a90aeacb2026-08-21WarningsExact identifier
application number: M003
hand sanitizer- light green 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598a165a-90ff-e00c-e063-6394a90a33512026-08-21WarningsExact identifier
application number: M003
Family Beauty Antibacterial Hand WipesBENZALKONIUM CHLORIDEZhejiang Bright Care Co., Ltd.6ff604f7-4011-4f0e-aa2d-a46e1a973d132026-08-21WarningsExact identifier
application number: M003
hand sanitizer- light purple 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598b7bb8-0d2e-a66f-e063-6294a90a45b82026-08-21WarningsExact identifier
application number: M003
hand sanitizer- light yellow 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598bf8cd-2a79-8b56-e063-6394a90a42a82026-08-21WarningsExact identifier
application number: M003
hand sanitizer- light pink 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598c41f0-908d-df52-e063-6394a90a3c8d2026-08-21WarningsExact identifier
application number: M003

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