Soothe And Hydrate Starter Set
NDC Package 69378-009-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Soothe And Hydrate Starter Set is • apply liberally and evenly 15 minutes before sun exposure and as needed • children under 6 months of age: Ask a doctor • Sun Protection Measures.S pending time in the sun increases your risk of skin cancer and early skin ageing, To decrease this risk, regularly use a sunscreen with a Broad SpectrumS PF value of 15 or higher and other sun protection measures including· limit time in the sun, especially from 1 0a.m. Marketed by Acheson & Acheson Ltd., this product is identified by NDC 69378-009 and is authorized under FDA application part352.

Identification & Billing

NDC Package Code
69378-009-01
Package Description
1 BOX in 1 CONTAINER / 1 KIT in 1 BOX * 15 g in 1 TUBE (69378-001-16) * 2 GEL in 1 CONTAINER
Product Code
69378-009
11-Digit Billing Format
69378000901

Clinical Specifications

Proprietary Name
Soothe And Hydrate Starter Set
Dosage Form
-
Usage Information
• apply liberally and evenly 15 minutes before sun exposure and as needed • children under 6 months of age: Ask a doctor • Sun Protection Measures.S pending time in the sun increases your risk of skin cancer and early skin ageing, To decrease this risk, regularly use a sunscreen with a Broad SpectrumS PF value of 15 or higher and other sun protection measures including· limit time in the sun, especially from 1 0a.m. - 2 p.m. • wear long-sleeved shirts. pants. hats. and sunglasses• reapply at least every 2 hours• use a water resistant sunscreen if swimming or sweating

Regulatory & Marketing

Labeler Name
Acheson & Acheson Ltd.
FDA Application #
part352
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
10-01-2021
Listing Expiration
12-31-2023
Exclude Flag
I
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 69378-009-01 identifies a specific commercial package of 1 box in 1 container / 1 kit in 1 box * 15 g in 1 tube (69378-001-16) * 2 gel in 1 container of Soothe And Hydrate Starter Set, labeled by Acheson & Acheson Ltd.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Acheson & Acheson Ltd. on October 01, 2021. The current certification is valid through December 31, 2023.

How is this Acheson & Acheson Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69378000901. 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)
69378-009-01
11-Digit CMS (5-4-2)
69378-0009-01

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