Home NDC 58345-105 Key Dermolac
Product NDC 58345-105
11-digit product format 583450105
Labeler code 58345
Product ID 58345-105_2b26c2ec-601b-7dd5-e063-6294a90aaaa7
Type HUMAN OTC DRUG
Nonproprietary name Jabon antiseptico a base de acido lactico
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 2024-07-02
Substance LACTIC ACID, L-
Active strength 1.6 g/100mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Key Dermolac
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LACTIC ACID, L- 1.6 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F9S9FFU82N Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58345-105 KEY DERMOLAC (JABON ANTISEPTICO A BASE DE ACIDO LACTICO) LIQUID [KEY QUÍMICA S.A. DE C.V.] 2 Current NDC, 6 package rows 20250109_1c368292-4c33-8488-e063-6294a90a0fa9.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 58345-105-01 58345010501 3 BAG in 1 BOX (58345-105-01) / 800 mL in 1 BAG 3 bag 2024-07-02 No No Current 58345-105-02 58345010502 4 BOTTLE in 1 BOX (58345-105-02) / 4000 mL in 1 BOTTLE 4 bottle 2024-07-02 No No Current 58345-105-03 58345010503 4 BOTTLE, PUMP in 1 BOX (58345-105-03) / 4000 mL in 1 BOTTLE, PUMP 2024-07-02 No No Current