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
ALCOHOL; CHLORHEXIDINE GLUCONATE
Active strength
70; .97 mL/100mL; g/100mL
Pharmacologic classes
Decreased Cell Wall Integrity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Solucion Antiseptica Dermoxine
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M, MOR84MUD8E

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

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