FDA.reportPublic FDA data

Key Dermoxine Jabon Espuma

Product NDC
58345-104
11-digit product format
583450104
Labeler code
58345
Product ID
58345-104_2b26a872-c29f-8486-e063-6294a90ab023
Type
HUMAN OTC DRUG
Nonproprietary name
Jabon Antiseptico en espuma
Dosage form
LIQUID
Route
TOPICAL
Labeler
Key Qu�mica S.A. de C.V.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-29
Substance
CHLORHEXIDINE GLUCONATE
Active strength
4.2 g/100mL
Pharmacologic classes
Decreased Cell Wall Integrity [PE]
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
Key Dermoxine Jabon Espuma
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORHEXIDINE GLUCONATE4.2 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MOR84MUD8EInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1743684f-647d-0949-e063-6294a90a7d37Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58345-104-01Key Dermoxine Jabon Espuma1000 mL in 1 BOTTLE, PUMPLIQUID10003
58345-104-01Key Dermoxine Jabon Espuma3 in 1 BOXLIQUID33
58345-104-02Key Dermoxine Jabon Espuma3 in 1 BOXLIQUID33
58345-104-02Key Dermoxine Jabon Espuma1000 mL in 1 BAGLIQUID10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58345-104KEY DERMOXINE JABON ESPUMA (JABON ANTISEPTICO EN ESPUMA) LIQUID [KEY QUÍMICA S.A. DE C.V.]3Current NDC, 4 package rows20250109_1743684f-647d-0949-e063-6294a90a7d37.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
Key Dermoxine Jabon EspumaJABON ANTISEPTICO EN ESPUMAKey Qumica S.A. de C.V.1743684f-647d-0949-e063-6294a90a7d372025-01-07WarningsExact identifier
ndc (product): 58345-104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58345-104-01583450104013 BOTTLE, PUMP in 1 BOX (58345-104-01) / 1000 mL in 1 BOTTLE, PUMP2024-04-29NoNoCurrent
58345-104-02583450104023 BAG in 1 BOX (58345-104-02) / 1000 mL in 1 BAG3 bag2024-04-29NoNoCurrent