FDA.reportPublic FDA data

FOAMING HAND

Product NDC
83019-103
11-digit product format
830190103
Labeler code
83019
Product ID
83019-103_23f9338f-4538-64ed-e063-6394a90ada99
Type
HUMAN OTC DRUG
Nonproprietary name
CHLOROXYLENOL
Dosage form
SOAP
Route
TOPICAL
Labeler
Draco Hygienic Products Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-25
Substance
CHLOROXYLENOL
Active strength
.45 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
FOAMING HAND
Brand name suffix
ANTIBACTERIAL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLOROXYLENOL.45 g/100mL

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
2002728Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
15256355-29ef-9b24-e063-6294a90a907dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83019-103-11FOAMING HANDANTIBACTERIAL1000 mL in 1 CONTAINERSOAP10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83019-103FOAMING HAND ANTIBACTERIAL (CHLOROXYLENOL) SOAP [DRACO HYGIENIC PRODUCTS INC.]2Current NDC, 1 package rows20241010_15256355-29ef-9b24-e063-6294a90a907d.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 77 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AshleyBelle Moisturizing Hand Sanitizer RainfallETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.36a68ecb-3216-eeb2-e063-6294a90a5bba2025-06-03WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer RainfallETHYL ALCOHOL 70%MY IMPORTS USA LLC36a7b358-131c-88fc-e063-6394a90a007f2025-06-03WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Citrus GroveETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.36a7bbf0-166b-54dc-e063-6294a90a1c162025-06-03WarningsExact identifier
application number: M003
Scent Theory Hand Sanitizer Sprays (Blissful Cherry, Candy Cane Cocoa, Molten Marshmallows)ALCOHOLScent Theory Products LLC36b0eec0-33b2-2055-e063-6394a90af7302025-06-03WarningsExact identifier
application number: M003
Scent Theory Hand Sanitizer Sprays (Pink Champagne, Harvest Berry, Cozy Coconut)ALCOHOLScent Theory Products LLC36b105ef-82a5-7f95-e063-6394a90a8c1b2025-06-03WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Citrus GroveETHYL ALCOHOL 70%MY IMPORTS USA LLC36b4fb1c-9b19-63c3-e063-6394a90a5e352025-06-03WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Spearmint EucalyptusETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.36b55178-6f31-85a9-e063-6394a90a56bc2025-06-03WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sunflower HazeETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.36b5ebda-1448-bc40-e063-6294a90af6d42025-06-03WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla CashmereETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.36b63138-8ec9-e84a-e063-6394a90a68e32025-06-03WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Spearmint EucalyptusETHYL ALCOHOL 70%MY IMPORTS USA LLC36b6d0e4-8d9f-9df5-e063-6294a90af3262025-06-03WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sunflower HazeETHYL ALCOHOL 70%MY IMPORTS USA LLC36b71ebe-0638-73e8-e063-6394a90a9f4e2025-06-03WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla CashmereETHYL ALCOHOL 70%MY IMPORTS USA LLC36b73e99-293a-865b-e063-6394a90a39c42025-06-03WarningsExact identifier
application number: M003
Biopure 3 Hydrogen PeroxideHYDROGEN PEROXIDEQuest USA Corp1e34d066-f82c-484c-87bf-aa54fb1fac072025-06-02WarningsExact identifier
application number: M003
Simply Saline Wound CareBENZETHONIUM CHLORIDE 0.13%Church & Dwight Co., Inc.6c802e91-b69e-cdd0-e053-2991aa0aa7812025-06-01WarningsExact identifier
application number: M003
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd39a5a4a2-983e-a4e7-e063-6394a90aa27c2025-06-01WarningsExact identifier
application number: M003
BerbereX Wound CleanserBENZETHONIUM CHLORIDECosco International, Inc.08b28f52-21fc-4694-a163-91c8193b40082025-05-30WarningsExact identifier
application number: M003
Op-First Aid Series Povidone Iodine Prep PadPOVIDONE-IODINEYiwu Ori-Power Medtech Co.,Ltd.32dc994b-6636-72d8-e063-6294a90a98f62025-05-29WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Apple Pear CloveETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.363e549a-c432-9f2e-e063-6394a90ae8862025-05-28WarningsExact identifier
application number: M003
Quality Choice Hydrogen Peroxide WipesHYDROGEN PEROXIDEChain Drug Marketing Association, Incc2822eb6-8a2a-4337-acce-6f7fc84961752025-05-26WarningsExact identifier
application number: M003
VLITEPRO First Aid WipesISOPROPYL ALCOHOL CLOTHYiwu Ori-Power Medtech Co., Ltd.35a7873a-e340-aae3-e063-6294a90a767f2025-05-26WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2002728chloroxylenol 0.45 % Medicated Liquid SoapPSN15256355-29ef-9b24-e063-6294a90a907d2
2002728chloroxylenol 4.5 MG/ML Medicated Liquid SoapSCD15256355-29ef-9b24-e063-6294a90a907d2
2002728chloroxylenol 0.45 % Medicated Liquid SoapSY15256355-29ef-9b24-e063-6294a90a907d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83019-103-11830190103111000 mL in 1 CONTAINER (83019-103-11) 1000 ml2024-03-25NoNoCurrent