Cerave Developed With Dermatologists Itch Relief Moisturizing Lotion
NDC Package 49967-970-01

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

Package Information

Cerave Developed With Dermatologists Itch Relief Moisturizing (pramoxine hydrochloride) lotions is adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times dailyChildren under 2 years of age: consult a doctor. This formulation utilizes a lotion delivery system. Marketed by L'oreal Usa Products Inc, this product is identified by NDC 49967-970 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
49967-970-01
Package Description
237 mL in 1 BOTTLE, PUMP
Product Code
49967-970
11-Digit Billing Format
49967097001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
237 ML

Clinical Specifications

Proprietary Name
Cerave Developed With Dermatologists Itch Relief Moisturizing
Non-Proprietary Name
Pramoxine Hydrochloride
Substance Name
Pramoxine Hydrochloride
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)
PRAMOXINE HYDROCHLORIDE 1 mg/mL
Usage Information
Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times dailyChildren under 2 years of age: consult a doctor.

Regulatory & Marketing

Labeler Name
L'oreal Usa Products Inc
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-17-2017
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (49967-970). Click a package code to view its specific billing and regulatory data.

49967-970-02
15 BOTTLE in 1 TRAY / 29.6 mL in 1 BOTTLE
49967-970-03
473 mL in 1 BOTTLE
49967-970-04
562 mL in 1 BOTTLE

* 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 49967-970-01 identifies a specific commercial package of 237 ml in 1 bottle, pump of Cerave Developed With Dermatologists Itch Relief Moisturizing, a human over the counter drug labeled by L'oreal Usa Products Inc. This product is billed per "ML" milliliter and contains an estimated amount of 237 billable units per package. This lotion is formulated for topical use and contains pramoxine hydrochloride 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 L'oreal Usa Products Inc on August 17, 2017. The current certification is valid through December 31, 2027.

How is this L'oreal Usa Products Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49967097001. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 237 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 (5-3-2)
49967-970-01
11-Digit CMS (5-4-2)
49967-0970-01

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