Good Sense Clear Lax Powder, For Solution
NDC Package 71205-447-38

11-digit billing NDC: 71205044738
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Good Sense Clear Lax (polyethylene glycol 3350) powders is •do not take more than directed unless advised by your doctor•the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line (white section in cap)•adults and children 17 years of age and older:•fill to top of white section in cap which is marked to indicate the correct dose (17 g)•stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink•use once a day•use no more than 7 days•children 16 years of age or under: ask a doctor. This formulation utilizes a powder, for solution delivery system. Marketed by Proficient Rx Lp, this product is identified by NDC 71205-447 and is authorized under FDA application ANDA090685.

Identification & Billing

NDC Package Code
71205-447-38
Package Description
238 g in 1 BOTTLE
Product Code
71205-447
11-Digit Billing Format
71205044738

Clinical Specifications

Proprietary Name
Good Sense Clear Lax
Non-Proprietary Name
Polyethylene Glycol 3350
Substance Name
Polyethylene Glycol 3350
Dosage Form
Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
POLYETHYLENE GLYCOL 3350 17 g/17g
Pharmacologic Class
Usage Information
•do not take more than directed unless advised by your doctor•the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line (white section in cap)•adults and children 17 years of age and older:•fill to top of white section in cap which is marked to indicate the correct dose (17 g)•stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink•use once a day•use no more than 7 days•children 16 years of age or under: ask a doctor

Regulatory & Marketing

Labeler Name
Proficient Rx Lp
Product Type
Human Otc Drug
FDA Application #
ANDA090685
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-07-2009
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 71205-447-38 identifies a specific commercial package of 238 g in 1 bottle of Good Sense Clear Lax, a human over the counter drug labeled by Proficient Rx Lp. This powder, for solution is formulated for oral use and contains polyethylene glycol 3350 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 Proficient Rx Lp on October 07, 2009. The current certification is valid through December 31, 2027.

How is this Proficient Rx Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71205044738. 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)
71205-447-38
11-Digit CMS (5-4-2)
71205-0447-38

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