Hemorrhoidalointment
NDC Package 68016-528-00

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

Package Information

Hemorrhoidalointment (mineral oil, petrolatum, phenylephrine hci) ointment is children under 12 years of age: ask a doctor before useAdults: when practical, clean the affected area by patting or blotting with an appropriate cleansing wipegently dry by patting or blotting with a tissue or soft cloth before applyingwhen first opening tube, remove foil sealfor intrarectal use: remove protective cover from applicator into the rectumlubricate applicator well, then gently insert applicator into the rectumthoroughly clean applicator and replace protective cover after each useapply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movementalso apply ointment to external area. This formulation utilizes a ointment delivery system. Marketed by Pharmacy Value Alliance, Llc, this product is identified by NDC 68016-528 and is authorized under FDA application M015.

Identification & Billing

NDC Package Code
68016-528-00
Package Description
1 TUBE in 1 BOX / 57 g in 1 TUBE
Product Code
68016-528
11-Digit Billing Format
68016052800
RxNorm Crosswalk
  • RxCUI: 1372298 - mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal Ointment
  • RxCUI: 1372298 - mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal Ointment
  • RxCUI: 1372298 - mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal Ointment

Clinical Specifications

Proprietary Name
Hemorrhoidalointment
Non-Proprietary Name
Mineral Oil, Petrolatum, Phenylephrine Hci
Substance Name
Mineral Oil; Petrolatum; Phenylephrine Hydrochloride
Dosage Form
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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)
Pharmacologic Class
Usage Information
Children under 12 years of age: ask a doctor before useAdults: when practical, clean the affected area by patting or blotting with an appropriate cleansing wipegently dry by patting or blotting with a tissue or soft cloth before applyingwhen first opening tube, remove foil sealfor intrarectal use: remove protective cover from applicator into the rectumlubricate applicator well, then gently insert applicator into the rectumthoroughly clean applicator and replace protective cover after each useapply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movementalso apply ointment to external area

Regulatory & Marketing

Labeler Name
Pharmacy Value Alliance, Llc
Product Type
Human Otc Drug
FDA Application #
M015
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-19-2016
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68016-528-00 identifies a specific commercial package of 1 tube in 1 box / 57 g in 1 tube of Hemorrhoidalointment, a human over the counter drug labeled by Pharmacy Value Alliance, Llc. This ointment is formulated for topical use and contains mineral oil; petrolatum; phenylephrine hydrochloride 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 Pharmacy Value Alliance, Llc on July 19, 2016. The current certification is valid through December 31, 2026.

How is this Pharmacy Value Alliance, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68016052800. 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)
68016-528-00
11-Digit CMS (5-4-2)
68016-0528-00

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