Home NDC 58345-103 Gel Antiseptico Dermowipe
Product NDC 58345-103
11-digit product format 583450103
Labeler code 58345
Product ID 58345-103_2b26aa61-8365-58d9-e063-6294a90ae76b
Type HUMAN OTC DRUG
Nonproprietary name Gel antiseptico a base de alcohol etilico
Dosage form GEL
Route TOPICAL
Labeler Key Qu�mica S.A. de C.V.
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-04-05
Substance ALCOHOL
Active strength 70 mL/70mL
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 Gel Antiseptico Dermowipe
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALCOHOL 70 mL/70mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3K9958V90M Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58345-103-01 Gel Antiseptico Dermowipe 12 in 1 BOX GEL 12 2 58345-103-01 Gel Antiseptico Dermowipe 300 mL in 1 BOTTLE, PUMP GEL 300 2 58345-103-02 Gel Antiseptico Dermowipe 960 mL in 1 BOTTLE, PUMP GEL 960 2 58345-103-02 Gel Antiseptico Dermowipe 6 in 1 BOX GEL 6 2 58345-103-03 Gel Antiseptico Dermowipe 6 in 1 BOX GEL 6 2 58345-103-03 Gel Antiseptico Dermowipe 800 mL in 1 BAG GEL 800 2 58345-103-04 Gel Antiseptico Dermowipe 3 in 1 BOX GEL 3 2 58345-103-04 Gel Antiseptico Dermowipe 1000 mL in 1 BOTTLE GEL 1000 2 58345-103-05 Gel Antiseptico Dermowipe 4 in 1 BOX GEL 4 2 58345-103-05 Gel Antiseptico Dermowipe 4000 mL in 1 BOTTLE GEL 4000 2 58345-103-06 Gel Antiseptico Dermowipe 20000 mL in 1 BOTTLE GEL 20000 2 58345-103-07 Gel Antiseptico Dermowipe 1000 mL in 1 BOTTLE, PUMP GEL 1000 2 58345-103-07 Gel Antiseptico Dermowipe 3 in 1 BOX GEL 3 2 58345-103-08 Gel Antiseptico Dermowipe 4000 mL in 1 BOTTLE, PUMP GEL 4000 2 58345-103-08 Gel Antiseptico Dermowipe 2 in 1 BOX GEL 2 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58345-103 GEL ANTISEPTICO DERMOWIPE (GEL ANTISEPTICO A BASE DE ALCOHOL ETILICO) GEL [KEY QUÍMICA S.A. DE C.V.] 2 Current NDC, 15 package rows 20250109_15620afc-d6ae-0f34-e063-6294a90a8ad2.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 58345-103-01 58345010301 12 BOTTLE, PUMP in 1 BOX (58345-103-01) / 300 mL in 1 BOTTLE, PUMP 2024-04-05 No No Current 58345-103-02 58345010302 6 BOTTLE, PUMP in 1 BOX (58345-103-02) / 960 mL in 1 BOTTLE, PUMP 2024-04-05 No No Current 58345-103-03 58345010303 6 BAG in 1 BOX (58345-103-03) / 800 mL in 1 BAG 6 bag 2024-04-05 No No Current 58345-103-04 58345010304 3 BOTTLE in 1 BOX (58345-103-04) / 1000 mL in 1 BOTTLE 3 bottle 2024-04-05 No No Current 58345-103-05 58345010305 4 BOTTLE in 1 BOX (58345-103-05) / 4000 mL in 1 BOTTLE 4 bottle 2024-04-05 No No Current 58345-103-06 58345010306 20000 mL in 1 BOTTLE (58345-103-06) 20000 ml 2024-04-05 No No Current 58345-103-07 58345010307 3 BOTTLE, PUMP in 1 BOX (58345-103-07) / 1000 mL in 1 BOTTLE, PUMP 2024-04-05 No No Current 58345-103-08 58345010308 2 BOTTLE, PUMP in 1 BOX (58345-103-08) / 4000 mL in 1 BOTTLE, PUMP 2024-04-05 No No Current