Thera Plus Vitamin A And D Cream
NDC Package 80684-135-01

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

Package Information

Thera Plus Vitamin A And D Cream (dimethicone, zinc oxide) cream is adults and children 2 years of age and older: apply generously and massage until absorbed. This formulation utilizes a cream delivery system. Marketed by Fourstar Group Usa, Inc., this product is identified by NDC 80684-135 and is authorized under FDA application M016.

Identification & Billing

NDC Package Code
80684-135-01
Package Description
42.5 g in 1 TUBE
Product Code
80684-135
11-Digit Billing Format
80684013501
RxNorm Crosswalk
  • RxCUI: 686403 - dimethicone 1 % / zinc oxide 10 % Topical Cream
  • RxCUI: 686403 - dimethicone 10 MG/ML / zinc oxide 100 MG/ML Topical Cream
  • RxCUI: 686403 - dimethicone 10 MG/ML / ZNO 100 MG/ML Topical Cream

Clinical Specifications

Proprietary Name
Thera Plus Vitamin A And D Cream
Non-Proprietary Name
Dimethicone, Zinc Oxide
Substance Name
Dimethicone; Zinc Oxide
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
Adults and children 2 years of age and older: apply generously and massage until absorbed. Repeat as necessary children under 2 years of age: ask a doctor before use

Regulatory & Marketing

Labeler Name
Fourstar Group Usa, Inc.
Product Type
Human Otc Drug
FDA Application #
M016
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-30-2025
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 80684-135-01 identifies a specific commercial package of 42.5 g in 1 tube of Thera Plus Vitamin A And D Cream, a human over the counter drug labeled by Fourstar Group Usa, Inc.. This cream is formulated for topical use and contains dimethicone; zinc oxide 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 Fourstar Group Usa, Inc. on April 30, 2025. The current certification is valid through December 31, 2027.

How is this Fourstar Group Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80684013501. 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)
80684-135-01
11-Digit CMS (5-4-2)
80684-0135-01

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