FDA.reportPublic FDA data

Hand Guard High Foaming Antiseptic Hand and Body Wash

Product NDC
31507-876
11-digit product format
315070876
Labeler code
31507
Product ID
31507-876_518d8242-5dc2-c37c-e063-6394a90a806c
Type
HUMAN OTC DRUG
Nonproprietary name
CHLOROXYLENOL
Dosage form
SOAP
Route
TOPICAL
Labeler
Wechem, Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-01-04
Substance
CHLOROXYLENOL
Active strength
3 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 22 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage31507-87631507-876-01DDiscontinued by firm2026-10-21
excluded packagepackage31507-87631507-876-03DDiscontinued by firm2026-10-21
excluded packagepackage31507-87631507-876-05DDiscontinued by firm2026-10-21
excluded packagepackage31507-87631507-876-06DDiscontinued by firm2026-10-21
excluded packagepackage31507-87631507-876-07DDiscontinued by firm2026-10-21
excluded packagepackage31507-87631507-876-08DDiscontinued by firm2026-10-21
excluded packagepackage31507-87631507-876-09DDiscontinued by firm2026-10-21
excluded packagepackage31507-87631507-876-10DDiscontinued by firm2026-10-21
excluded packagepackage31507-87631507-876-11DDiscontinued by firm2026-10-21
excluded packagepackage31507-87631507-876-13DDiscontinued by firm2026-10-21
excluded packagepackage31507-87631507-876-14DDiscontinued by firm2026-10-21
excluded packagepackage31507-87631507-876-15DDiscontinued by firm2026-10-21
excluded packagepackage31507-87631507-876-16DDiscontinued by firm2026-10-21
excluded packagepackage31507-87631507-876-17DDiscontinued by firm2026-10-21
excluded packagepackage31507-87631507-876-18DDiscontinued by firm2026-10-21
excluded packagepackage31507-87631507-876-19DDiscontinued by firm2026-10-21
excluded packagepackage31507-87631507-876-20DDiscontinued by firm2026-10-21
excluded packagepackage31507-87631507-876-24DDiscontinued by firm2026-10-21
excluded packagepackage31507-87631507-876-27DDiscontinued by firm2026-10-21
excluded packagepackage31507-87631507-876-28DDiscontinued by firm2026-10-21
excluded packagepackage31507-87631507-876-35DDiscontinued by firm2026-10-21
excluded packagepackage31507-87631507-876-55DDiscontinued by firm2026-10-21

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 · 22 matching rows.

View current auxiliary records. · View the auxiliary file history.

Package NDC table
Package NDC
31507-876-13
31507-876-20
31507-876-05
31507-876-17
31507-876-16
31507-876-18
31507-876-27
31507-876-28
31507-876-03
31507-876-06
31507-876-14
31507-876-01
31507-876-35
31507-876-08
31507-876-19
31507-876-10
31507-876-11
31507-876-07
31507-876-09
31507-876-15
31507-876-55
31507-876-24

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
Hand Guard High Foaming Antiseptic Hand and Body Wash
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
00956253-e0e8-49b7-9015-671a14f8df73Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31507-876-01Hand Guard High Foaming Antiseptic Hand and Body Wash1200 mL in 1 CARTRIDGESOAP12005
31507-876-03Hand Guard High Foaming Antiseptic Hand and Body Wash350 mL in 1 CARTRIDGESOAP3505
31507-876-05Hand Guard High Foaming Antiseptic Hand and Body Wash540 mL in 1 BOTTLE, PLASTICSOAP5405
31507-876-06Hand Guard High Foaming Antiseptic Hand and Body Wash800 mL in 1 BAGSOAP8005
31507-876-06Hand Guard High Foaming Antiseptic Hand and Body Wash1 in 1 BOXSOAP15
31507-876-07Hand Guard High Foaming Antiseptic Hand and Body Wash700 mL in 1 BAGSOAP7005
31507-876-08Hand Guard High Foaming Antiseptic Hand and Body Wash1 in 1 BOXSOAP15
31507-876-08Hand Guard High Foaming Antiseptic Hand and Body Wash1000 mL in 1 BAGSOAP10005
31507-876-09Hand Guard High Foaming Antiseptic Hand and Body Wash2000 mL in 1 CARTRIDGESOAP20005
31507-876-10Hand Guard High Foaming Antiseptic Hand and Body Wash1000 mL in 1 CARTRIDGESOAP10005
31507-876-11Hand Guard High Foaming Antiseptic Hand and Body Wash1000 mL in 1 BOTTLE, PLASTICSOAP10005
31507-876-12Hand Guard High Foaming Antiseptic Hand and Body Wash1000 mL in 1 BAGSOAP10005
31507-876-13Hand Guard High Foaming Antiseptic Hand and Body Wash800 mL in 1 BAGSOAP8005
31507-876-14Hand Guard High Foaming Antiseptic Hand and Body Wash3785 mL in 1 BOTTLE, PLASTICSOAP37855
31507-876-15Hand Guard High Foaming Antiseptic Hand and Body Wash946 mL in 1 BOTTLE, PLASTICSOAP9465
31507-876-16Hand Guard High Foaming Antiseptic Hand and Body Wash236 mL in 1 BOTTLE, PLASTICSOAP2365
31507-876-17Hand Guard High Foaming Antiseptic Hand and Body Wash532 mL in 1 BOTTLE, PLASTICSOAP5325
31507-876-18Hand Guard High Foaming Antiseptic Hand and Body Wash50 mL in 1 BOTTLE, PLASTICSOAP505
31507-876-19Hand Guard High Foaming Antiseptic Hand and Body Wash18900 mL in 1 CONTAINERSOAP189005
31507-876-20Hand Guard High Foaming Antiseptic Hand and Body Wash75600 mL in 1 DRUMSOAP756005
31507-876-24Hand Guard High Foaming Antiseptic Hand and Body Wash118 mL in 1 BOTTLE, PLASTICSOAP1185
31507-876-27Hand Guard High Foaming Antiseptic Hand and Body Wash800 mL in 1 CARTRIDGESOAP8005
31507-876-28Hand Guard High Foaming Antiseptic Hand and Body Wash149 mL in 1 BOTTLE, PLASTICSOAP1495
31507-876-35Hand Guard High Foaming Antiseptic Hand and Body Wash132500 mL in 1 DRUMSOAP1325005
31507-876-55Hand Guard High Foaming Antiseptic Hand and Body Wash208200 mL in 1 DRUMSOAP2082005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31507-876HAND GUARD HIGH FOAMING ANTISEPTIC HAND AND BODY WASH (CHLOROXYLENOL) SOAP [WECHEM, INC.]2Current NDC, Legacy NDC, 25 package rows20181229_00956253-e0e8-49b7-9015-671a14f8df73.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 89 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antibiotic ApplicationBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATECMC Group, Inc.da436c35-a98f-4df7-9d23-885564734cef2025-01-13WarningsExact identifier
application number: M003
Burn TreatmentBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDECMC Group Inc.9dd56b66-48c0-4bcf-a9a8-ba2f1e11ce402025-01-13WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLCMC Group Inc.dcca50e6-0935-401d-a23e-be4d1231dde92025-01-13WarningsExact identifier
application number: M003
Refill 2BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATECMC Group, Inc.45dde3f0-546c-4ec5-beb0-c3d0432f49832025-01-13WarningsExact identifier
application number: M003
Refill 3BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDECMC Group Inc.e5cb395f-5037-4b0e-9c9d-2d78b5b01b252025-01-13WarningsExact identifier
application number: M003
Refill 4ISOPROPYL ALCOHOLCMC Group Inc.6f4a4538-7522-4bcf-b3cf-8dea60438a4d2025-01-13WarningsExact identifier
application number: M003
Refill 6ALCOHOL, WATERCMC Group, Inc.7849ae59-5484-4b86-a0b9-ec9b93d9afe02025-01-13WarningsExact identifier
application number: M003
EVR Povidone lodine WipePOVIDONE LODINEChangzhou Maokang Medical Products Co., Ltd.2b57e301-74e0-e1db-e063-6294a90a6c182025-01-10WarningsExact identifier
application number: M003
EVR Sting Relief WipeBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.2b584d09-916c-00f8-e063-6294a90adbcf2025-01-10WarningsExact identifier
application number: M003
Medzah Ditek Alcohol Prep PadsISOPROPYL ALCOHOLMedzah Industries4e6e5b6b-147c-4e7c-9b8c-6a3116c4bdac2025-01-10WarningsExact identifier
application number: M003
Alcohol Prep Pad-LargeISOPROPYL ALCOHOLGlobal Biomedical Technologies, LLC93d00515-e93f-48a3-b66b-7d933e734e542025-01-10WarningsExact identifier
application number: M003
DERMADIVE ULTRACARE - TETRAIDBENZALKONIUM CHLORIDEReleaf Technologies LLC025c0b33-73ca-334b-e063-6394a90ad6682025-01-09WarningsExact identifier
application number: M003
Drs. pharmacy triple antibioticBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE OINTMENTOL PHARMA TECH, LLCbb730976-0045-c0ae-e053-2a95a90af34e2025-01-09WarningsExact identifier
application number: M003
Drs. Antibiotic BacitracinBACITRACINOL PHARMA TECH, LLCc26493c4-0bc1-5fdc-e053-2995a90a81e62025-01-09WarningsExact identifier
application number: M003
Drs. Pharmacy Triple Antibiotic PlusBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINEOL PHARMA TECH, LLC Drs PHARMACYd037bfb8-0d8c-4eda-e053-2995a90ae1f22025-01-09WarningsExact identifier
application number: M003
BACTINE MAXBACTINE MAX WOUND WASHWellSpring Pharmaceutical Corporation39b26c28-93e0-41a9-8018-f73525ebc0152025-01-08WarningsExact identifier
application number: M003
sterilePOVIDONE-IODINEAsia Dynamics Inc., d/b/a ADI Medical0658a0c8-f5ec-b380-e063-6394a90afff52025-01-08WarningsExact identifier
application number: M003
Betadine Surgical ScrubPOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.1ad39e11-ea1e-44a4-8224-93f8135436c22025-01-06WarningsExact identifier
application number: M003
First Aid AntisepticBENZALKONIUM CHLORIDEWater-Jel Technologies2b3cb958-c0c4-47fd-8338-7c7821135f2b2025-01-06WarningsExact identifier
application number: M003
Instant Hand SanitizerALCOHOLWater-Jel Technologies54e62104-8076-41db-afe5-6dc5c3563acc2025-01-06WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
413261chloroxylenol 0.3 % Medicated Liquid SoapPSN00956253-e0e8-49b7-9015-671a14f8df735
413261chloroxylenol 3 MG/ML Medicated Liquid SoapSCD00956253-e0e8-49b7-9015-671a14f8df735
413261chloroxylenol 0.3 % Medicated Liquid SoapSY00956253-e0e8-49b7-9015-671a14f8df735

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31507-876-01315070876011200 mL in 1 CARTRIDGE (31507-876-01) 1200 ml2017-01-040000-00-00NoNoCurrent
31507-876-0331507087603350 mL in 1 CARTRIDGE (31507-876-03) 350 ml2017-01-040000-00-00NoNoCurrent
31507-876-0531507087605540 mL in 1 BOTTLE, PLASTIC (31507-876-05) 540 ml2017-01-040000-00-00NoNoCurrent
31507-876-06315070876061 BAG in 1 BOX (31507-876-06) > 800 mL in 1 BAG1 bag2017-01-040000-00-00NoNoCurrent
31507-876-0731507087607700 mL in 1 BAG (31507-876-07) 700 ml2017-01-040000-00-00NoNoCurrent
31507-876-08315070876081 BAG in 1 BOX (31507-876-08) > 1000 mL in 1 BAG1 bag2017-01-040000-00-00NoNoCurrent
31507-876-09315070876092000 mL in 1 CARTRIDGE (31507-876-09) 2000 ml2017-01-040000-00-00NoNoCurrent
31507-876-10315070876101000 mL in 1 CARTRIDGE (31507-876-10) 1000 ml2017-01-040000-00-00NoNoCurrent
31507-876-11315070876111000 mL in 1 BOTTLE, PLASTIC (31507-876-11) 1000 ml2017-01-040000-00-00NoNoCurrent
31507-876-12315070876121000 mL in 1 BAG (31507-876-12) 1000 ml2017-01-040000-00-00NoNoCurrent
31507-876-1331507087613800 mL in 1 BAG (31507-876-13) 800 ml2017-01-040000-00-00NoNoCurrent
31507-876-14315070876143785 mL in 1 BOTTLE, PLASTIC (31507-876-14) 3785 ml2017-01-040000-00-00NoNoCurrent
31507-876-1531507087615946 mL in 1 BOTTLE, PLASTIC (31507-876-15) 946 ml2017-01-040000-00-00NoNoCurrent
31507-876-1631507087616236 mL in 1 BOTTLE, PLASTIC (31507-876-16) 236 ml2017-01-040000-00-00NoNoCurrent
31507-876-1731507087617532 mL in 1 BOTTLE, PLASTIC (31507-876-17) 532 ml2017-01-040000-00-00NoNoCurrent
31507-876-183150708761850 mL in 1 BOTTLE, PLASTIC (31507-876-18) 50 ml2017-01-040000-00-00NoNoCurrent
31507-876-193150708761918900 mL in 1 CONTAINER (31507-876-19) 18900 ml2017-01-040000-00-00NoNoCurrent
31507-876-203150708762075600 mL in 1 DRUM (31507-876-20) 75600 ml2017-01-040000-00-00NoNoCurrent
31507-876-2431507087624118 mL in 1 BOTTLE, PLASTIC (31507-876-24) 118 ml2017-01-040000-00-00NoNoCurrent
31507-876-2731507087627800 mL in 1 CARTRIDGE (31507-876-27) 800 ml2017-01-040000-00-00NoNoCurrent
31507-876-2831507087628149 mL in 1 BOTTLE, PLASTIC (31507-876-28) 149 ml2017-01-040000-00-00NoNoCurrent
31507-876-3531507087635132500 mL in 1 DRUM (31507-876-35) 132500 ml2017-01-040000-00-00NoNoCurrent
31507-876-5531507087655208200 mL in 1 DRUM (31507-876-55) 208200 ml2017-01-040000-00-00NoNoCurrent