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 60 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Luxury Hand Sanitizer Cashmere CharALCOHOLShenzhen Lantern Scicence Co.,Ltd.41938c11-391c-0a55-e063-6394a90ad4512025-10-20WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Tea and TimberALCOHOLShenzhen Lantern Scicence Co.,Ltd.4193d08a-bc54-ef3b-e063-6294a90a06082025-10-20WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Coastal CoconutETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.41940273-689d-0f44-e063-6294a90a957f2025-10-20WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Vanilla VerdantALCOHOLShenzhen Lantern Scicence Co.,Ltd.41942841-faa9-114e-e063-6294a90a0e582025-10-20WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Zen and ZestALCOHOLShenzhen Lantern Scicence Co.,Ltd.419441a8-a6df-e15d-e063-6294a90a02ae2025-10-20WarningsExact identifier
application number: M003
CVS Alcohol PrepISOPROPYL ALCOHOLCVS Pharmacy7abc66f2-faf6-421c-9c3c-b69f5a5872462025-10-20WarningsExact identifier
application number: M003
Gentian VioletGENTIAN VIOLETWorld Perfumes Inc419cc9a2-bfde-a516-e063-6294a90a065c2025-10-20WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Lavender DriftETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.41a2d051-4920-76ee-e063-6294a90a5d3c2025-10-20WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Peach NectarETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.41a36bb3-a648-3b5b-e063-6394a90aa4df2025-10-20WarningsExact identifier
application number: M003
PROHEAL ALCOHOL XXL PREP PADSISOPROPYL ALCOHOLClick Industries LLCec81be59-94a5-4675-9047-e3e82d7ad7612025-10-20WarningsExact identifier
application number: M003
ALCOHOL PREP PADISOPROPYL ALCOHOLGuangdong Comfort Medical Products Co., Ltd.3a2dea43-8123-3fb7-e063-6294a90a5e502025-10-19WarningsExact identifier
application number: M003
ANTISEPTIC WIPEBENZALKONIUM CHLORIDEGuangdong Comfort Medical Products Co., Ltd.3a40a31d-4032-71ba-e063-6294a90a48dc2025-10-19WarningsExact identifier
application number: M003
ANTIBACTERIAL BANDAGESBENZALKONIUM CHLORIDEGuangdong Comfort Medical Products Co., Ltd.6e43b8b3-2d49-8f76-e053-2a91aa0affb02025-10-19WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Soft BerryETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.418fed84-d4ab-7352-e063-6294a90a6dab2025-10-19WarningsExact identifier
application number: M003
BZK CLEANSERBENZALKONIUM CHLORIDEGeri-Gentle Corporation415eb5fb-5f88-d2dd-e063-6394a90abe5d2025-10-17WarningsExact identifier
application number: M003
Medline Alcohol Prep Sterile, LargeISOPROPYL ALCOHOLMedline Industries, LPc9fae7b6-2f4b-490b-9b17-a7297e7380692025-10-16WarningsExact identifier
application number: M003
Medline Alcohol Prep Sterile, MediumISOPROPYL ALCOHOLMedline Industries, LP9a8584e1-b422-4b77-8464-4e022d578fad2025-10-16WarningsExact identifier
application number: M003
Signature Select Pain RelievingLIDOCAINE HCL, BENZALKONIUM CHLORIDESafeway/Albartsons3cab1b0c-4ffd-9c01-e063-6294a90ad15d2025-10-16WarningsExact identifier
application number: M003
Medline Alcohol PrepISOPROPYL ALCOHOLMedline Industries, LPb43c0bff-82f8-c18d-e053-2995a90a87162025-10-16WarningsExact identifier
application number: M003
MedlineBENZALKONIUM CHLORIDE, LIDOCAIN HYDROCHLORIDEMedline Industries, LPb1059e68-b240-056c-e053-2995a90a61b22025-10-16WarningsExact 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