Bunnies Bum Soothing Hemorrhoidal Cream
NDC Package 84308-161-02

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

Package Information

Bunnies Bum Soothing Hemorrhoidal (glycerin, lidocaine, petrolatum, phenylephrine hcl) cream is for the temporary relief of pain, soreness, and burningHelps relieve the local itching and discomfort associated with hemorrhoidsTemporarily shrinks hemorrhoidal tissueTemporarily provides a costing for the relief of anorectal discomfortsTemporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful. This formulation utilizes a cream delivery system. Marketed by Flocal Distributors Llc, this product is identified by NDC 84308-161 and is authorized under FDA application M015.

Identification & Billing

NDC Package Code
84308-161-02
Package Description
57 g in 1 TUBE
Product Code
84308-161
11-Digit Billing Format
84308016102
RxNorm Crosswalk
  • RxCUI: 2642220 - glycerin 14.4 % / lidocaine 5 % / phenylephrine HCl 0.25 % / white petrolatum 15 % Rectal Cream
  • RxCUI: 2642220 - glycerin 144 MG/ML / lidocaine 50 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal Cream

Clinical Specifications

Proprietary Name
Bunnies Bum Soothing Hemorrhoidal
Non-Proprietary Name
Glycerin, Lidocaine, Petrolatum, Phenylephrine Hcl
Substance Name
Glycerin; Lidocaine; Petrolatum; Phenylephrine Hydrochloride
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)
Pharmacologic Class
Usage Information
For the temporary relief of pain, soreness, and burningHelps relieve the local itching and discomfort associated with hemorrhoidsTemporarily shrinks hemorrhoidal tissueTemporarily provides a costing for the relief of anorectal discomfortsTemporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Regulatory & Marketing

Labeler Name
Flocal Distributors Llc
Product Type
Human Otc Drug
FDA Application #
M015
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-08-2024
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 84308-161-02 identifies a specific commercial package of 57 g in 1 tube of Bunnies Bum Soothing Hemorrhoidal, a human over the counter drug labeled by Flocal Distributors Llc. This cream is formulated for topical use and contains glycerin; lidocaine; 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 Flocal Distributors Llc on July 08, 2024. The current certification is valid through December 31, 2026.

How is this Flocal Distributors Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84308016102. 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)
84308-161-02
11-Digit CMS (5-4-2)
84308-0161-02

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