Sunmark Caldiphen Lotion
NDC Package 49348-337-36

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

Package Information

Sunmark Caldiphen (calamine and pramoxine hydrochloride) lotions is adults and children 2 yr. This formulation utilizes a lotion delivery system. Marketed by Strategic Sourcing Services, this product is identified by NDC 49348-337 and is authorized under FDA application M016.

Identification & Billing

NDC Package Code
49348-337-36
Package Description
177 mL in 1 BOTTLE, PLASTIC
Product Code
49348-337
11-Digit Billing Format
49348033736
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: 1234532 - calamine 8 % / pramoxine HCl 1 % Topical Lotion
  • RxCUI: 1234532 - calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion
  • RxCUI: 1234532 - calamine 8 % / pramoxine hydrochloride 1 % Topical Lotion

Clinical Specifications

Proprietary Name
Sunmark Caldiphen
Non-Proprietary Name
Calamine And Pramoxine Hydrochloride
Substance Name
Pramoxine Hydrochloride; Zinc Oxide
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
Adults and children 2 yr. of age and older. Shake well before using. Cleanse the skin with soap and water and let dry. Apply to the affected area using cotton or soft cloth, not more than 3 to 4 times daily as needed for comfort.Children under 2 yrs. of age. Consult a doctor before use.

Regulatory & Marketing

Labeler Name
Strategic Sourcing Services
Product Type
Human Otc Drug
FDA Application #
M016
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-25-1998
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 49348-337-36 identifies a specific commercial package of 177 ml in 1 bottle, plastic of Sunmark Caldiphen, a human over the counter drug labeled by Strategic Sourcing Services. This lotion is formulated for topical use and contains pramoxine hydrochloride; 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 Strategic Sourcing Services on March 25, 1998. The current certification is valid through December 31, 2026.

How is this Strategic Sourcing Services product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49348033736. 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 (5-3-2)
49348-337-36
11-Digit CMS (5-4-2)
49348-0337-36

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