Labella Linimento Obrero
NDC Package 31774-8005-1

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Labella Linimento Obrero is use only as directed.Adults and children 2 years of age or older: apply to affected area not more than 3 to 4 times daily.Children under 2 years of age: consult a physician. Marketed by Golden Sun Inc Dba Newhall Laboratories, this product is identified by NDC 31774-8005 and is authorized under FDA application part346.

Identification & Billing

NDC Package Code
31774-8005-1
Package Description
236 mL in 1 BOTTLE, PLASTIC
Product Code
31774-8005
11-Digit Billing Format
31774800501
RxNorm Crosswalk
  • RxCUI: 1721014 - capsaicin 0.025 % / menthol 2 % / methyl salicylate 10 % Topical Cream
  • RxCUI: 1721014 - capsaicin 0.25 MG/ML / menthol 20 MG/ML / methyl salicylate 100 MG/ML Topical Cream

Clinical Specifications

Proprietary Name
Labella Linimento Obrero
Dosage Form
-
Usage Information
Use only as directed.Adults and children 2 years of age or older: apply to affected area not more than 3 to 4 times daily.Children under 2 years of age: consult a physician.

Regulatory & Marketing

Labeler Name
Golden Sun Inc Dba Newhall Laboratories
FDA Application #
part346
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
01-02-2013
Listing Expiration
12-31-2017
Exclude Flag
I
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 31774-8005-1 identifies a specific commercial package of 236 ml in 1 bottle, plastic of Labella Linimento Obrero, labeled by Golden Sun Inc Dba Newhall Laboratories. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Golden Sun Inc Dba Newhall Laboratories on January 02, 2013. The current certification is valid through December 31, 2017.

How is this Golden Sun Inc Dba Newhall Laboratories product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 31774800501. 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 (5-4-1)
31774-8005-1
11-Digit CMS (5-4-2)
31774-8005-01

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