Preparation H Kit
NDC Package 0573-2884-12

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

Package Information

Preparation H (cocoa butter, phenylephrine hydrochloride, and witch hazel) kits is adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. This formulation utilizes a kit delivery system. Marketed by Haleon Us Holdings Llc, this product is identified by NDC 0573-2884 and is authorized under FDA application M015.

Identification & Billing

NDC Package Code
0573-2884-12
Package Description
1 KIT in 1 CARTON * 12 SUPPOSITORY in 1 BLISTER PACK * 4 CLOTH in 1 APPLICATOR
Product Code
0573-2884
11-Digit Billing Format
00573288412
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Preparation H
Non-Proprietary Name
Cocoa Butter, Phenylephrine Hydrochloride, And Witch Hazel
Dosage Form
Kit - A packaged collection of related material.
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 insertion of this product.detach one suppository from the strip; remove the foil wrapper before inserting into the rectum as follows:hold suppository with rounded end upas shown, carefully separate foil tabs by inserting tip of fingernail at end marked "peel down"slowly and evenly peel apart (do not tear) foil by pulling tabs down both sides, to expose the suppositoryremove exposed suppository from wrapperinsert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movementchildren under 12 years of age: ask a doctor adults: unfold wipe and cleanse the area by gently wiping, patting or blotting. If necessary, repeat until all matter is removed from the area.use up to 6 times daily or after each bowel movement and before applying topical hemorrhoidal treatments, and then discardchildren under 12 years of age: consult a doctor

Regulatory & Marketing

Labeler Name
Haleon Us Holdings Llc
Product Type
Human Otc Drug
FDA Application #
M015
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-01-2015
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 0573-2884-12 identifies a specific commercial package of 1 kit in 1 carton * 12 suppository in 1 blister pack * 4 cloth in 1 applicator of Preparation H, a human over the counter drug labeled by Haleon Us Holdings Llc. This kit is formulated for use and contains 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 Haleon Us Holdings Llc on July 01, 2015. The current certification is valid through December 31, 2026.

How is this Haleon Us Holdings Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00573288412. 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 (4-4-2)
0573-2884-12
11-Digit CMS (5-4-2)
00573-2884-12

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