3% Hydrogen Peroxide Solution
NDC Package 52000-433-16

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

Package Information

3% Hydrogen Peroxide (hydrogen peroxide) solution is first aid antiseptic:• clean the affected area • apply a small amount of product on the affected area 1 to 3 times a day • may be covered with a sterile bandage • if bandaged, let dry firstFor use as an oral debriding agent (oral rinse)• adults and children over 2 years of age:  • mix with an equal amount of water  • swish around in the mouth over affected area for at least 1 minute and then spit out. This formulation utilizes a solution delivery system. Marketed by Universal Distribution Center Llc, this product is identified by NDC 52000-433 and is authorized under FDA application M003.

Identification & Billing

NDC Package Code
52000-433-16
Package Description
473 mL in 1 BOTTLE, PLASTIC
Product Code
52000-433
11-Digit Billing Format
52000043316
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
3% Hydrogen Peroxide
Non-Proprietary Name
Hydrogen Peroxide
Substance Name
Hydrogen Peroxide
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
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)
HYDROGEN PEROXIDE 3 mL/100mL
Usage Information
First aid antiseptic:• clean the affected area • apply a small amount of product on the affected area 1 to 3 times a day • may be covered with a sterile bandage • if bandaged, let dry firstFor use as an oral debriding agent (oral rinse)• adults and children over 2 years of age:  • mix with an equal amount of water  • swish around in the mouth over affected area for at least 1 minute and then spit out. Do not swallow  • use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor• children under 12 years should be supervised in the use of this product• children under 2 years of age: consult a dentist or doctor

Regulatory & Marketing

Labeler Name
Universal Distribution Center Llc
Product Type
Human Otc Drug
FDA Application #
M003
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-08-2025
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (52000-433). Click a package code to view its specific billing and regulatory data.

52000-433-32
946 mL in 1 BOTTLE, PLASTIC

* 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 52000-433-16 identifies a specific commercial package of 473 ml in 1 bottle, plastic of 3% Hydrogen Peroxide, a human over the counter drug labeled by Universal Distribution Center Llc. This solution is formulated for topical use and contains hydrogen peroxide 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 Universal Distribution Center Llc on December 08, 2025. The current certification is valid through December 31, 2026.

How is this Universal Distribution Center Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52000043316. 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)
52000-433-16
11-Digit CMS (5-4-2)
52000-0433-16

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