FDA.reportPublic FDA data

Antiseptic Hand

Product NDC
16496-544
11-digit product format
164960544
Labeler code
16496
Product ID
16496-544_518c3d6c-f385-3c63-e063-6294a90ab136
Type
HUMAN OTC DRUG
Nonproprietary name
CHLOROXYLENOL
Dosage form
SOAP
Route
TOPICAL
Labeler
Image Supply, Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-09-30
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
Antiseptic Hand
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
7edd2630-bd0b-473f-85ab-34c74e8a3a0fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16496-544-14Antiseptic Hand3785 mL in 1 BOTTLE, PLASTICSOAP37854

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLOROXYLENOLACTIVE INGREDIENT0F32U78V2QANTISEPTIC HAND (CHLOROXYLENOL) SOAP [IMAGE SUPPLY, INC.]1
CHLOROXYLENOLACTIVE MOIETY0F32U78V2QANTISEPTIC HAND (CHLOROXYLENOL) SOAP [IMAGE SUPPLY, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPANTISEPTIC HAND (CHLOROXYLENOL) SOAP [IMAGE SUPPLY, INC.]1
COCO MONOISOPROPANOLAMIDEINACTIVE INGREDIENT21X4Y0VTB1ANTISEPTIC HAND (CHLOROXYLENOL) SOAP [IMAGE SUPPLY, INC.]1
DECYL GLUCOSIDEINACTIVE INGREDIENTZ17H97EA6YANTISEPTIC HAND (CHLOROXYLENOL) SOAP [IMAGE SUPPLY, INC.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MANTISEPTIC HAND (CHLOROXYLENOL) SOAP [IMAGE SUPPLY, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ANTISEPTIC HAND (CHLOROXYLENOL) SOAP [IMAGE SUPPLY, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XANTISEPTIC HAND (CHLOROXYLENOL) SOAP [IMAGE SUPPLY, INC.]1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0ANTISEPTIC HAND (CHLOROXYLENOL) SOAP [IMAGE SUPPLY, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RANTISEPTIC HAND (CHLOROXYLENOL) SOAP [IMAGE SUPPLY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16496-544ANTISEPTIC HAND (CHLOROXYLENOL) SOAP [IMAGE SUPPLY, INC.]2Current NDC, Legacy NDC, 1 package rows20181229_7edd2630-bd0b-473f-85ab-34c74e8a3a0f.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 116 · 2,320 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer with Glitter Silicone Case,2pk Vanilla Chai and EspressoALCOHOLShenzhen Lantern Scicence Co.,Ltd.59ef14d6-1a40-ea3c-e063-6394a90af4422026-08-26WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer,4pk with Silicone Case,Cherry Blossom /Gardenia /Lavender Vanilla/ Coconut HoneyALCOHOLShenzhen Lantern Scicence Co.,Ltd.59ef6f47-1c65-2ab7-e063-6394a90a86f22026-08-26WarningsExact 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
Henry Schein Povidone-Iodine Prep PadPOVIDONE-IODINEHenry Schein, Inc.313416b8-60b2-4a77-9b56-5c507aae90722026-08-25WarningsExact identifier
application number: M003
School HealthISOPROPYL ALCOHOLSchool Health Corporationdb5d0b22-f2d7-23e5-e053-2a95a90aeb512026-08-24WarningsExact identifier
application number: M003
Curad Alcohol Prep Pads MediumISOPROPYL ALCOHOLMedline Industries, LP1ce3872e-2307-4a38-bd7d-7eb2b226cf3c2026-08-24WarningsExact 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
Smart Care Hand Sanitizer with Glitter Silicone Case , 2pk Champagne Toast and Sparkling PomegranateALCOHOLShenzhen Lantern Scicence Co.,Ltd.597530cb-03f6-b72d-e063-6394a90a0d6c2026-08-20WarningsExact identifier
application number: M003
Olimpo AntibacterialBENZALKONIUM CHLORIDE 0.1%Industria La Popular, S.A.597e3b3e-51f0-5fcf-e063-6394a90ac2972026-08-20WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLMcKesson485e35b9-3aac-3cab-e063-6394a90ac1e72026-08-18WarningsExact identifier
application number: M003
inControl alcoholISOPROPYL ALCOHOLH-E-B45dfbd7a-0ae1-4146-9527-5483c884e6362026-08-18WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEThe Kroger Co.52f6258f-4b4c-49f4-9bc7-40dc3918869d2026-08-17Warnings, Adverse reactionsExact identifier
application number: M003
70% Isopropyl Rubbing AlcoholISOPROPYL RUBBING ALCOHOLThe Kroger Co.b127bba1-ce0b-4142-8b7d-f12f062b09382026-08-17Warnings, Adverse reactionsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
413261chloroxylenol 0.3 % Medicated Liquid SoapPSN7edd2630-bd0b-473f-85ab-34c74e8a3a0f4
413261chloroxylenol 3 MG/ML Medicated Liquid SoapSCD7edd2630-bd0b-473f-85ab-34c74e8a3a0f4
413261chloroxylenol 0.3 % Medicated Liquid SoapSY7edd2630-bd0b-473f-85ab-34c74e8a3a0f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16496-544-14164960544143785 mL in 1 BOTTLE, PLASTIC (16496-544-14) 3785 ml2005-09-300000-00-00NoNoCurrent