Summit 368 Foaming Antimicrobial Hand

Product NDC
23590-225
11-digit product format
235900225
Labeler code
23590
Product ID
23590-225_5450c41f-6381-4d7f-e063-6294a90af55a
Type
HUMAN OTC DRUG
Nonproprietary name
Chloroxylenol
Dosage form
SOLUTION
Route
TOPICAL
Labeler
R.L. Williams Company
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-06-15
Substance
CHLOROXYLENOL
Active strength
7.5 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
Summit 368 Foaming Antimicrobial Hand
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLOROXYLENOL7.5 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
1045003Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5450def0-8bba-48af-e063-6294a90a46b0Available on FDA.report

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
Summit 368 Foaming Antimicrobial HandCHLOROXYLENOLR.L. Williams Company5450def0-8bba-48af-e063-6294a90a46b02026-06-15WarningsExact identifier
ndc (product): 23590-225

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
23590-225-8523590022585850 mL in 1 BOTTLE, PUMP (23590-225-85) 850 ml2026-06-15NoNoCurrent