FDA.reportPublic FDA data

Antimicrobial Hand SP

Product NDC
83919-600
11-digit product format
839190600
Labeler code
83919
Product ID
83919-600_2a971e38-af67-e069-e063-6294a90a8f77
Type
HUMAN OTC DRUG
Nonproprietary name
Chloroxylenol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Envoy Solutions, LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-04-26
Substance
CHLOROXYLENOL
Active strength
.3 mg/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
Antimicrobial Hand SP
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLOROXYLENOL.3 mg/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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f96a1be8-1b44-4d9c-8e75-ac686696069eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83919-600-42Antimicrobial Hand SP1250 mL in 1 PACKAGELIQUID12502
83919-600-67Antimicrobial Hand SP2000 mL in 1 PACKAGELIQUID20002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83919-600ANTIMICROBIAL HAND SP (CHLOROXYLENOL) LIQUID [ENVOY SOLUTIONS, LLC]2Current NDC, 2 package rows20250101_f96a1be8-1b44-4d9c-8e75-ac686696069e.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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antimicrobial Hand SPCHLOROXYLENOLEnvoy Solutions, LLCf96a1be8-1b44-4d9c-8e75-ac686696069e2024-12-31WarningsExact identifier
ndc (product): 83919-600

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83919-600-42839190600421250 mL in 1 PACKAGE (83919-600-42) 1250 ml2023-09-01NoNoCurrent
83919-600-67839190600672000 mL in 1 PACKAGE (83919-600-67) 2000 ml2022-04-26NoNoCurrent