Hydrocortisone Cream 0.5% Cream
NDC Package 46122-830-36

11-digit billing NDC: 46122083036
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Hydrocortisone Cream 0.5% (hydrocortisone cream 0.5% with aloe) cream is • for itching of skin irritation, inflammation, and rashes: • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily • children under 2 years of age: ask a doctor • for external anal and genital itching, adults: • when practical, clean the affected area with mild soap and warm water and rinse thoroughly • gently dry by patting or blotting with toilet tissue or a soft cloth before applying • apply to affected area not more than 3 to 4 times daily • children under 12 years of age: ask a doctor. This formulation utilizes a cream delivery system. Marketed by Amerisourcebergen, this product is identified by NDC 46122-830 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
46122-830-36
Package Description
1 TUBE in 1 CARTON / 28.4 g in 1 TUBE
Product Code
46122-830
11-Digit Billing Format
46122083036

Clinical Specifications

Proprietary Name
Hydrocortisone Cream 0.5% With Aloe
Non-Proprietary Name
Hydrocortisone Cream 0.5% With Aloe
Substance Name
Hydrocortisone
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)
HYDROCORTISONE .5 g/100g
Pharmacologic Class
Usage Information
• for itching of skin irritation, inflammation, and rashes: • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily • children under 2 years of age: ask a doctor • for external anal and genital itching, adults: • when practical, clean the affected area with mild soap and warm water and rinse thoroughly • gently dry by patting or blotting with toilet tissue or a soft cloth before applying • apply to affected area not more than 3 to 4 times daily • children under 12 years of age: ask a doctor

Regulatory & Marketing

Labeler Name
Amerisourcebergen
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-02-2026
Listing Expiration
12-31-2027
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 46122-830-36 identifies a specific commercial package of 1 tube in 1 carton / 28.4 g in 1 tube of Hydrocortisone Cream 0.5% With Aloe, a human over the counter drug labeled by Amerisourcebergen. This cream is formulated for topical use and contains hydrocortisone 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 Amerisourcebergen on November 02, 2026. The current certification is valid through December 31, 2027.

How is this Amerisourcebergen product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46122083036. 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)
46122-830-36
11-Digit CMS (5-4-2)
46122-0830-36

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