FDA.reportPublic FDA data

Solucion Antiseptica Dermoxine

Product NDC
58345-106
11-digit product format
583450106
Labeler code
58345
Product ID
58345-106_226b154a-8e17-365a-e063-6394a90ae163
Type
HUMAN OTC DRUG
Nonproprietary name
Solucion antiseptica topica a base de alcohol etilico
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
2024-09-18
Substance
CHLORHEXIDINE GLUCONATE; ALCOHOL
Active strength
.97; 70 g/100mL; mL/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
Solucion Antiseptica Dermoxine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORHEXIDINE GLUCONATE.97 g/100mL
ALCOHOL70 mL/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MOR84MUD8EInternal UNII lookup
3K9958V90MInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
226b154a-8e16-365a-e063-6394a90ae163Available 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
58345-106-01Solucion Antiseptica Dermoxine500 mL in 1 BOTTLE, PUMPLIQUID5001
58345-106-01Solucion Antiseptica Dermoxine12 in 1 BOXLIQUID121
58345-106-02Solucion Antiseptica Dermoxine3 in 1 BOXLIQUID31
58345-106-02Solucion Antiseptica Dermoxine1000 mL in 1 BOTTLELIQUID10001
58345-106-03Solucion Antiseptica Dermoxine1000 mL in 1 BOTTLE, PUMPLIQUID10001
58345-106-03Solucion Antiseptica Dermoxine3 in 1 BOXLIQUID31
58345-106-04Solucion Antiseptica Dermoxine4 in 1 BOXLIQUID41
58345-106-04Solucion Antiseptica Dermoxine4000 mL in 1 BOTTLELIQUID40001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58345-106SOLUCION ANTISEPTICA DERMOXINE (SOLUCION ANTISEPTICA TOPICA A BASE DE ALCOHOL ETILICO) LIQUID [KEY QUÍMICA S.A. DE C.V.]1Current NDC, 8 package rows20240920_226b154a-8e16-365a-e063-6394a90ae163.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
Solucion Antiseptica DermoxineSOLUCION ANTISEPTICA TOPICA A BASE DE ALCOHOL ETILICOKey Qumica S.A. de C.V.226b154a-8e16-365a-e063-6394a90ae1632024-09-18WarningsExact identifier
ndc (product): 58345-106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58345-106-015834501060112 BOTTLE, PUMP in 1 BOX (58345-106-01) / 500 mL in 1 BOTTLE, PUMP2024-09-18NoNoCurrent
58345-106-02583450106023 BOTTLE in 1 BOX (58345-106-02) / 1000 mL in 1 BOTTLE3 bottle2024-09-18NoNoCurrent
58345-106-03583450106033 BOTTLE, PUMP in 1 BOX (58345-106-03) / 1000 mL in 1 BOTTLE, PUMP2024-09-18NoNoCurrent
58345-106-04583450106044 BOTTLE in 1 BOX (58345-106-04) / 4000 mL in 1 BOTTLE4 bottle2024-09-18NoNoCurrent