Olp Hemorrhoidal Cooling
NDC Package 70648-009-01

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.

Olp Hemorrhoidal Cooling is adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Marketed by Ohio Lab Pharma, this product is identified by NDC 70648-009 and is authorized under FDA application part346.

Identification & Billing

NDC Package Code
70648-009-01
Package Description
1 TUBE in 1 CARTON / 20 g in 1 TUBE
Product Code
70648-009
11-Digit Billing Format
70648000901
RxNorm Crosswalk
  • RxCUI: 249465 - phenylephrine HCl 0.25 % / witch hazel 50 % Rectal Gel
  • RxCUI: 249465 - phenylephrine 0.0025 MG/MG / witch hazel 0.5 MG/MG Rectal Gel
  • RxCUI: 249465 - phenylephrine 0.25 % / witch hazel 50 % Rectal Gel

Clinical Specifications

Proprietary Name
Olp Hemorrhoidal Cooling
Dosage Form
-
Usage Information
Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying gel.when first opening the tube, puncture foil seal with top end of capapply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movementchildren under 12 years of age: ask a doctor

Regulatory & Marketing

Labeler Name
Ohio Lab Pharma
FDA Application #
part346
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
02-01-2017
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 70648-009-01 identifies a specific commercial package of 1 tube in 1 carton / 20 g in 1 tube of Olp Hemorrhoidal Cooling, labeled by Ohio Lab Pharma. 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 Ohio Lab Pharma on February 01, 2017. The current certification is valid through December 31, 2019.

How is this Ohio Lab Pharma product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70648000901. 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)
70648-009-01
11-Digit CMS (5-4-2)
70648-0009-01

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