FDA.reportPublic FDA data

EVERSOFT FOAMING HAND

Product NDC
83019-101
Requested package NDC
83019-101-11
11-digit product format
830190101
Labeler code
83019
Product ID
83019-101_23f91e01-f193-708c-e063-6294a90a28a1
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
2022-09-29
Substance
CHLOROXYLENOL
Active strength
.45 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
EVERSOFT FOAMING HAND
Brand name suffix
ANTI-BACTERIAL
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
e9d4767b-21f2-b68f-e053-2995a90a5abaAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83019-101-112024-10-08C16284748780-11030e365-3a70-111a-e063-dadaa90a10e2DRACO (as PLD) - EVERSOFT FOAMING HAND SOAP (83019-101)
83019-101-112024-01-30C16284748780-11030e365-3a70-111a-e063-dadaa90a10e2DRACO (as PLD) - EVERSOFT FOAMING HAND SOAP (83019-101)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83019-101-11EVERSOFT FOAMING HANDANTI-BACTERIAL1000 mL in 1 CONTAINERSOAP10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83019-101EVERSOFT FOAMING HAND ANTI-BACTERIAL (CHLOROXYLENOL) SOAP [DRACO HYGIENIC PRODUCTS INC.]2Current NDC, Legacy NDC, 1 package rows20241010_e9d4767b-21f2-b68f-e053-2995a90a5aba.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 52 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMORA Spray. Hand Sanitizer coconutALCOHOLLongway Technology(Guangzhou) Co., Ltd.44fcf3d3-439b-7869-e063-6294a90a19c32025-12-02WarningsExact identifier
application number: M003
MedPride Instant SanitizerALCOHOLSHIELD LINE LLCa1c87c06-d4d2-cd0f-e053-2995a90a4eaa2025-12-02WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Caramel HoneyALCOHOLShenzhen Lantern Scicence Co.,Ltd.450401c9-2098-9a23-e063-6394a90a20842025-12-02WarningsExact identifier
application number: M003
AMORA Spray. Hand Sanitizer CherryALCOHOLLongway Technology(Guangzhou) Co., Ltd.44e04959-a21e-ba62-e063-6394a90a71922025-12-01WarningsExact identifier
application number: M003
Hand SanitizerETHYL ALCOHOLL&R Distributors, Inc.263457cc-35ff-62fb-e063-6394a90a94da2025-12-01WarningsExact identifier
application number: M003
Hand SanitizerETHYL ALCOHOLL&R Distributors, Inc.2507df2c-9069-01c1-e063-6394a90a85962025-12-01WarningsExact identifier
application number: M003
T.N. Dickinsons Wound CleansingBENZALKONIUM CHLORIDE, PRAMOXINE HYDROCHLORIDEDickinson Brands Inc.c2a8b134-8bb3-4e00-9df4-3229cb372da02025-12-01WarningsExact identifier
application number: M003
safeHands Hand Sanitizer Clean LinenBENZALKONIUM CHLORIDESafehands Distribution Ne, LLC86cc04dc-b66d-4d97-b8da-f5e41f2d13d52025-11-29WarningsExact identifier
application number: M003
safeHands Hand Sanitizer Fragrance FreeBENZALKONIUM CHLORIDESafehands Distribution Ne, LLC0e7af9f7-80a1-4347-89c4-7d9c8b55d65d2025-11-29WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLC5376a031-b657-47d4-bf41-c393fdec040b2025-11-28WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLC2298e131-3b0c-4104-bf48-5c366d763d452025-11-28WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLCbe8b96a2-c4a2-41f8-959b-0fe349cff37e2025-11-28WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLCb35cb3d0-1a2d-4ffc-a32e-faa2ca1312ee2025-11-28WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLCcef2d3d4-bd5f-4f2a-bb2d-5292b78501c12025-11-28WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLC90d6fe21-7b41-4429-8c03-4d35e66a3b292025-11-28WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLC87aaabb6-d121-464f-993d-5182de13d49e2025-11-28WarningsExact identifier
application number: M003
FF SILICONE SPRY SANI PPKFF SILICONE SPRY SANI PPKZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD4493c534-187e-f680-e063-6294a90aacdb2025-11-27WarningsExact identifier
application number: M003
Walgreen Maximum strength pain relieving cleansingBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDEWALGREENS CO.9a0443a2-f1a9-482d-b5ee-abe983e4ae322025-11-26WarningsExact identifier
application number: M003
WalgreensFIRST AID ANTISEPTICWalgreensae731d28-8530-4dd0-aef7-b25f784b47772025-11-26WarningsExact identifier
application number: M003
Hand SanitizerETHYL ALCOHOLHAIAN KANGRUI TEXTILE CO., LTD.44677bab-41ea-3392-e063-6394a90a61872025-11-25WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2002728chloroxylenol 0.45 % Medicated Liquid SoapPSNe9d4767b-21f2-b68f-e053-2995a90a5aba2
2002728chloroxylenol 4.5 MG/ML Medicated Liquid SoapSCDe9d4767b-21f2-b68f-e053-2995a90a5aba2
2002728chloroxylenol 0.45 % Medicated Liquid SoapSYe9d4767b-21f2-b68f-e053-2995a90a5aba2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83019-101-11830190101111000 mL in 1 CONTAINER (83019-101-11) 1000 ml2022-09-290000-00-00NoNoCurrent