Calamine Clear Lotion
NDC Package 70000-0397-1

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

Package Information

Calamine Clear (pramoxine hydrochloride and zinc acetate lotion) lotions is temporarily Relieves Pain and Itching Associated with:rashes due to poison ivy, poison oak, or poison sumac insect bites minor skin irritation minor cuts dries the oozing and weeping of poison ivy, poison oak and poison sumac. This formulation utilizes a lotion delivery system. Marketed by Cardinal Health, 110 Dba Leader, this product is identified by NDC 70000-0397 and is authorized under FDA application M016.

Identification & Billing

NDC Package Code
70000-0397-1
Package Description
177 mL in 1 BOTTLE, PLASTIC
Product Code
70000-0397
11-Digit Billing Format
70000039701
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
177 ML
RxNorm Crosswalk
  • RxCUI: 1234546 - pramoxine HCl 1 % / zinc acetate 0.1 % Topical Lotion
  • RxCUI: 1234546 - pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical Lotion

Clinical Specifications

Proprietary Name
Calamine Clear
Non-Proprietary Name
Pramoxine Hydrochloride And Zinc Acetate Lotion
Substance Name
Pramoxine Hydrochloride; Zinc Acetate
Dosage Form
Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
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
Temporarily Relieves Pain and Itching Associated with:rashes due to poison ivy, poison oak, or poison sumac insect bites minor skin irritation minor cuts dries the oozing and weeping of poison ivy, poison oak and poison sumac

Regulatory & Marketing

Labeler Name
Cardinal Health, 110 Dba Leader
Product Type
Human Otc Drug
FDA Application #
M016
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-15-2019
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 70000-0397-1 identifies a specific commercial package of 177 ml in 1 bottle, plastic of Calamine Clear, a human over the counter drug labeled by Cardinal Health, 110 Dba Leader. This lotion is formulated for topical use and contains pramoxine hydrochloride; zinc acetate 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 Cardinal Health, 110 Dba Leader on January 15, 2019. The current certification is valid through December 31, 2026.

How is this Cardinal Health, 110 Dba Leader product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70000039701. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 177 total billable units per package. 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 (5-4-1)
70000-0397-1
11-Digit CMS (5-4-2)
70000-0397-01

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