Witch Hazel Liquid
NDC Package 36800-039-16

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

Package Information

Witch Hazel liquids is apply to the affected area as often as necessary. This formulation utilizes a liquid delivery system. Marketed by Top Care (topco Associates Llc), this product is identified by NDC 36800-039 and is authorized under FDA application M016.

Identification & Billing

NDC Package Code
36800-039-16
Package Description
473 mL in 1 BOTTLE, PLASTIC
Product Code
36800-039
11-Digit Billing Format
36800003916

Clinical Specifications

Proprietary Name
Witch Hazel
Non-Proprietary Name
Witch Hazel
Substance Name
Witch Hazel
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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)
WITCH HAZEL 842 mg/mL
Usage Information
Apply to the affected area as often as necessary.

Regulatory & Marketing

Labeler Name
Top Care (topco Associates Llc)
Product Type
Human Otc Drug
FDA Application #
M016
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-31-2014
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 36800-039-16 identifies a specific commercial package of 473 ml in 1 bottle, plastic of Witch Hazel, a human over the counter drug labeled by Top Care (topco Associates Llc). This liquid is formulated for topical use and contains witch hazel 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 Top Care (topco Associates Llc) on October 31, 2014. The current certification is valid through December 31, 2026.

How is this Top Care (topco Associates Llc) product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36800003916. 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)
36800-039-16
11-Digit CMS (5-4-2)
36800-0039-16

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