Key Dermolac Liquid
NDC Package 58345-105-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Key Dermolac (jabon antiseptico a base de acido lactico) liquids is wet hands thoroughly with product ant rise at the end. This formulation utilizes a liquid delivery system. Marketed by Key Qu�mica S.a. De C.v., this product is identified by NDC 58345-105 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
58345-105-01
Package Description
3 BAG in 1 BOX / 800 mL in 1 BAG
Product Code
58345-105
11-Digit Billing Format
58345010501

Clinical Specifications

Proprietary Name
Key Dermolac
Non-Proprietary Name
Jabon Antiseptico A Base De Acido Lactico
Substance Name
Lactic Acid, L-
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
LACTIC ACID, L- 1.6 g/100mL
Usage Information
Wet hands thoroughly with product ant rise at the end.

Regulatory & Marketing

Labeler Name
Key Qu�mica S.a. De C.v.
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-02-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (58345-105). Click a package code to view its specific billing and regulatory data.

58345-105-02
4 BOTTLE in 1 BOX / 4000 mL in 1 BOTTLE
58345-105-03
4 BOTTLE, PUMP in 1 BOX / 4000 mL in 1 BOTTLE, PUMP

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 58345-105-01 identifies a specific commercial package of 3 bag in 1 box / 800 ml in 1 bag of Key Dermolac, a human over the counter drug labeled by Key Qu�mica S.a. De C.v.. This liquid is formulated for topical use and contains lactic acid, l- as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Key Qu�mica S.a. De C.v. on July 02, 2024. The current certification is valid through December 31, 2026.

How is this Key Qu�mica S.a. De C.v. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58345010501. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
58345-105-01
11-Digit CMS (5-4-2)
58345-0105-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.