Sanlonghemorrhoidradicalantilnflammatoryointment Cream
NDC Package 85189-001-01

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

Package Information

Sanlonghemorrhoidradicalantilnflammatoryointment cream is a medication used as Treating hemorrhoids. This formulation utilizes a cream delivery system. Marketed by Heyuan Sanlong Trading Co., Ltd, this product is identified by NDC 85189-001 and is authorized under FDA application M015.

Identification & Billing

NDC Package Code
85189-001-01
Package Description
1 g in 1 BOX
Product Code
85189-001
11-Digit Billing Format
85189000101

Clinical Specifications

Proprietary Name
Sanlonghemorrhoidradicalantilnflammatoryointment
Non-Proprietary Name
Sanlonghemorrhoidradicalantilnflammatoryointment
Substance Name
Styphnolobium Japonicum Flower
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 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)
STYPHNOLOBIUM JAPONICUM FLOWER 1 g/100g
Usage Information
This product is used as Treating hemorrhoids. Clean the affected area. When the affectedarea is located in the perianal area, usedisposable gloves to apply the gel to theaffected area. When the affected area is in theinternal anal position, use a disposable bolusto inject the gel into the anus slowly into theanus, push an appropriate amount of gel intothe rectum and withdraw the bolus. One timein the morning and evening, three days for acourse of treatment.

Regulatory & Marketing

Labeler Name
Heyuan Sanlong Trading Co., Ltd
Product Type
Human Otc Drug
FDA Application #
M015
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-24-2025
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 85189-001-01 identifies a specific commercial package of 1 g in 1 box of Sanlonghemorrhoidradicalantilnflammatoryointment, a human over the counter drug labeled by Heyuan Sanlong Trading Co., Ltd. This cream is formulated for topical use and contains styphnolobium japonicum flower 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 Heyuan Sanlong Trading Co., Ltd on January 24, 2025. The current certification is valid through December 31, 2026.

How is this Heyuan Sanlong Trading Co., Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85189000101. 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)
85189-001-01
11-Digit CMS (5-4-2)
85189-0001-01

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