Premierpro Flushable Wipes With Dimethicone
NDC Package 61312-010-01

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.

Premierpro Flushable Wipes With Dimethicone is pull back label and remove wipes• Thoroughly cleanse soiled area, using one wipe at a time•Use as often as necessary•Dispose of cloths in a waste receptacle•Do not flush Heating Instructions:• Wipes may be used at room temperature but if heating is desired, wipes may be warmed in a wipes warmer. Marketed by Hangzhou Guoguang Touring Commodity Co., Ltd., this product is identified by NDC 61312-010 and is authorized under FDA application part347.

Identification & Billing

NDC Package Code
61312-010-01
Package Description
24 PACKAGE in 1 CASE / 216 g in 1 PACKAGE
Product Code
61312-010
11-Digit Billing Format
61312001001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Premierpro Flushable Wipes With Dimethicone
Dosage Form
-
Usage Information
Pull back label and remove wipes• Thoroughly cleanse soiled area, using one wipe at a time•Use as often as necessary•Dispose of cloths in a waste receptacle•Do not flush Heating Instructions:• Wipes may be used at room temperature but if heating is desired, wipes may be warmed in a wipes warmer. Wipes should be warmed:• in a single warming session at temperatures not exceeding 52°C (125°F) and • for a maximum of 4 days. Discard wipes that have been: • Exposed to warming temperatures exceeding 52C (125F); or• Stored longer than 4 days within the warmer; or• Been warmed, allowed to cool, and then re-warmed.

Regulatory & Marketing

Labeler Name
Hangzhou Guoguang Touring Commodity Co., Ltd.
FDA Application #
part347
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
07-13-2017
Listing Expiration
12-31-2019
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 61312-010-01 identifies a specific commercial package of 24 package in 1 case / 216 g in 1 package of Premierpro Flushable Wipes With Dimethicone, labeled by Hangzhou Guoguang Touring Commodity Co., Ltd.. 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 Hangzhou Guoguang Touring Commodity Co., Ltd. on July 13, 2017. The current certification is valid through December 31, 2019.

How is this Hangzhou Guoguang Touring Commodity Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61312001001. 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)
61312-010-01
11-Digit CMS (5-4-2)
61312-0010-01

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