FDA.reportPublic FDA data

Chemseptic

Product NDC
59503-0544
Requested package NDC
59503-0544-2
11-digit product format
595030544
Labeler code
59503
Product ID
59503-0544_518cda00-2343-eb46-e063-6294a90afc52
Type
HUMAN OTC DRUG
Nonproprietary name
CHLOROXYLENOL
Dosage form
SOAP
Route
TOPICAL
Labeler
Rochester Midland Corporation
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2004-03-30
Substance
CHLOROXYLENOL
Active strength
3 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
Chemseptic
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
f3109c8d-c684-47a7-b26a-32e3ba64b838Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59503-0544-1Chemseptic532 mL in 1 BOTTLE, PLASTICSOAP5325
59503-0544-2Chemseptic3785 mL in 1 BOTTLE, PLASTICSOAP37855
59503-0544-3Chemseptic18900 mL in 1 PAILSOAP189005
59503-0544-4Chemseptic208200 mL in 1 DRUMSOAP2082005
59503-0544-5Chemseptic946 mL in 1 BOTTLE, PLASTICSOAP9465
59503-0544-6Chemseptic2500 mL in 1 BOTTLE, PLASTICSOAP25005
59503-0544-7Chemseptic75600 mL in 1 DRUMSOAP756005
59503-0544-8Chemseptic132500 mL in 1 DRUMSOAP1325005
59503-0544-9Chemseptic650 mL in 1 BAGSOAP6505

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLOROXYLENOLACTIVE INGREDIENT0F32U78V2QCHEMSEPTIC (CHLOROXYLENOL) SOAP [ROCHESTER MIDLAND CORPORATION]1
CHLOROXYLENOLACTIVE MOIETY0F32U78V2QCHEMSEPTIC (CHLOROXYLENOL) SOAP [ROCHESTER MIDLAND CORPORATION]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCHEMSEPTIC (CHLOROXYLENOL) SOAP [ROCHESTER MIDLAND CORPORATION]1
COCO MONOISOPROPANOLAMIDEINACTIVE INGREDIENT21X4Y0VTB1CHEMSEPTIC (CHLOROXYLENOL) SOAP [ROCHESTER MIDLAND CORPORATION]1
DECYL GLUCOSIDEINACTIVE INGREDIENTZ17H97EA6YCHEMSEPTIC (CHLOROXYLENOL) SOAP [ROCHESTER MIDLAND CORPORATION]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MCHEMSEPTIC (CHLOROXYLENOL) SOAP [ROCHESTER MIDLAND CORPORATION]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHEMSEPTIC (CHLOROXYLENOL) SOAP [ROCHESTER MIDLAND CORPORATION]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCHEMSEPTIC (CHLOROXYLENOL) SOAP [ROCHESTER MIDLAND CORPORATION]1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0CHEMSEPTIC (CHLOROXYLENOL) SOAP [ROCHESTER MIDLAND CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RCHEMSEPTIC (CHLOROXYLENOL) SOAP [ROCHESTER MIDLAND CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59503-0544CHEMSEPTIC (CHLOROXYLENOL) SOAP [ROCHESTER MIDLAND CORPORATION]3Current NDC, Legacy NDC, 9 package rows20181227_f3109c8d-c684-47a7-b26a-32e3ba64b838.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 74 of 114 · 2,270 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Universal 70% Rubbing Alcohol with Wintergreen and GlycerinUNIVERSAL 70% RUBBING ALCOHOL WITH WINTERGREEN AND GLYCERIN - ISOPROPYL ALCOHOL LIQUIDTSM BRANDS LLC390c6afd-e2c2-414c-e063-6294a90ae1192025-07-03WarningsExact identifier
application number: M003
RUBBING ALCOHOL 50 PERCENT WINTERGREENISOPROPYL ALCOHOLViny Health and Beauty Products Inc4b83f562-7ec7-72f3-e063-6294a90aba4d2025-07-01WarningsExact identifier
application number: M003
RUBBING ALCOHOL 50 PERCENTISOPROPYL ALCOHOLViny Health and Beauty Products Inc4b83e678-b79f-6dd6-e063-6294a90ad09d2025-07-01WarningsExact identifier
application number: M003
RUBBING ALCOHOL 70 PERCENTISOPROPYL ALCOHOLViny Health and Beauty Products Inc4babe369-3a35-34b5-e063-6394a90a68322025-07-01WarningsExact identifier
application number: M003
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd38c323e2-9a9a-f898-e063-6394a90aa2262025-06-30WarningsExact identifier
application number: M003
UNIVERSAL ISOPROPYL RUBBING ALCOHOL 70% - isopropyl alcohol liquidUNIVERSAL ISOPROPYL RUBBING ALCOHOL 70% - ISOPROPYL ALCOHOL LIQUIDTSM BRANDS LLC38d03665-6e76-c76f-e063-6294a90a9e332025-06-30WarningsExact identifier
application number: M003
HAND SANITIZER FRESH LINENALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd322e492b-0690-a345-e063-6294a90aef2c2025-06-29WarningsExact identifier
application number: M003
HAND SANITIZER VANILLAALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd322e98dd-22ec-d4a3-e063-6394a90a80fa2025-06-29WarningsExact identifier
application number: M003
HAND SANITIZER STRAWBERRY FIZZALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd322e3045-14dc-ac2e-e063-6394a90a9b8a2025-06-29WarningsExact identifier
application number: M003
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd38b857ee-760c-e98b-e063-6294a90a7c592025-06-29WarningsExact identifier
application number: M003
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd38b857ee-760e-e98b-e063-6294a90a7c592025-06-29WarningsExact identifier
application number: M003
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd38b87b19-7663-d5c5-e063-6294a90a9e872025-06-29WarningsExact identifier
application number: M003
Smart Care Assorted Hand Sanitizer -Passion FruitALCOHOLShenzhen Lantern Scicence Co.,Ltd.38895b60-f5a8-880f-e063-6394a90aa7062025-06-27WarningsExact identifier
application number: M003
Smart Care Assorted Hand Sanitizer -HibiscusALCOHOLShenzhen Lantern Scicence Co.,Ltd.3889d467-b179-bac4-e063-6394a90a61562025-06-27WarningsExact identifier
application number: M003
Smart Care Assorted Hand Sanitize -Cucumber MelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.388a975c-b0b6-b80e-e063-6294a90a18142025-06-27WarningsExact identifier
application number: M003
Smart Care Assorted Hand Sanitizer -Sweet CitrusALCOHOLShenzhen Lantern Scicence Co.,Ltd.388abca3-12fb-449a-e063-6394a90aea982025-06-27WarningsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINERugby Laboratoriesb2bcb69e-8ffb-23ee-e053-2995a90aee212025-06-27WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer - Caramel HoneyALCOHOLShenzhen Lantern Scicence Co.,Ltd.3874c203-2c8b-79b3-e063-6294a90aedfb2025-06-26WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer - Sweet CitrusALCOHOLShenzhen Lantern Scicence Co.,Ltd.38863865-9361-fd1a-e063-6394a90a84f42025-06-26WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer - Squishmallows PattyALCOHOLShenzhen Lantern Scicence Co.,Ltd.38613f78-8480-637d-e063-6394a90a4ef32025-06-25WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
413261chloroxylenol 0.3 % Medicated Liquid SoapPSNf3109c8d-c684-47a7-b26a-32e3ba64b8385
413261chloroxylenol 3 MG/ML Medicated Liquid SoapSCDf3109c8d-c684-47a7-b26a-32e3ba64b8385
413261chloroxylenol 0.3 % Medicated Liquid SoapSYf3109c8d-c684-47a7-b26a-32e3ba64b8385

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59503-0544-2595030544023785 mL in 1 BOTTLE, PLASTIC (59503-0544-2) 3785 ml2004-03-300000-00-00NoNoCurrent