Acne Pellet
NDC Package 55714-2385-1

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

Package Information

Acne (antimon. crud., arsenicum alb., aur. met., berber. aqui., bovista, carbo veg., causticum, chelidonium majus, dulcamara, graphites, hepar sulph. calc., hydrocotyle, kali brom., kali iod., ledum, lycopodium, nux vom., silicea, sulphur iod., zinc. met., echinacea, juglans regia, lappa, taraxacum) pellets is formulated for symptoms associated with acne and other skin conditions such as boils, pimples, pustules and sebaceous cysts. This formulation utilizes a pellet delivery system. Marketed by Newton Laboratories, Inc., this product is identified by NDC 55714-2385.

Identification & Billing

NDC Package Code
55714-2385-1
Package Description
28 g in 1 BOTTLE, GLASS
Product Code
55714-2385
11-Digit Billing Format
55714238501

Clinical Specifications

Proprietary Name
Acne
Non-Proprietary Name
Antimon. Crud., Arsenicum Alb., Aur. Met., Berber. Aqui., Bovista, Carbo Veg., Causticum, Chelidonium Majus, Dulcamara, Graphites, Hepar Sulph. Calc., Hydrocotyle, Kali Brom., Kali Iod., Ledum, Lycopodium, Nux Vom., Silicea, Sulphur Iod., Zinc. Met., Echinacea, Juglans Regia, Lappa, Taraxacum
Substance Name
Activated Charcoal; Antimony Trisulfide; Arctium Lappa Root; Arsenic Cation (3+); Calcium Sulfide; Causticum; Centella Asiatica; Chelidonium Majus; Echinacea, Unspecified; English Walnut; Giant Puffball; Gold; Graphite; Ledum Palustre Twig; Lycopodium Clavatum Spore; Mahonia Aquifolium Root Bark; Potassium Bromide; Potassium Iodide; Silicon Dioxide; Solanum Dulcamara Top; Strychnos Nux-vomica Seed; Sulfur Iodide; Taraxacum Officinale; Zinc
Dosage Form
Pellet - A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Formulated for symptoms associated with acne and other skin conditions such as boils, pimples, pustules and sebaceous cysts.

Regulatory & Marketing

Labeler Name
Newton Laboratories, Inc.
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date
10-31-2018
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 55714-2385-1 identifies a specific commercial package of 28 g in 1 bottle, glass of Acne, a human over the counter drug labeled by Newton Laboratories, Inc.. This pellet is formulated for oral use and contains activated charcoal; antimony trisulfide; arctium lappa root; arsenic cation (3+); calcium sulfide; causticum; centella asiatica; chelidonium majus; echinacea, unspecified; english walnut; giant puffball; gold; graphite; ledum palustre twig; lycopodium clavatum spore; mahonia aquifolium root bark; potassium bromide; potassium iodide; silicon dioxide; solanum dulcamara top; strychnos nux-vomica seed; sulfur iodide; taraxacum officinale; zinc 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 Newton Laboratories, Inc. on October 31, 2018. The current certification is valid through December 31, 2026.

How is this Newton Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55714238501. 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 (5-4-1)
55714-2385-1
11-Digit CMS (5-4-2)
55714-2385-01

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