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  5. NDC Package Code: 71355-819-03 Pure Haven Essentials

NDC Package 71355-819-03 Pure Haven Essentials

Titanium Dioxide,Zinc Oxide Cream Topical - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
71355-819-03
Package Description:
90 mL in 1 TUBE
Product Code:
71355-819
Proprietary Name:
Pure Haven Essentials
Non-Proprietary Name:
Titanium Dioxide, Zinc Oxide
Substance Name:
Titanium Dioxide; Zinc Oxide
Usage Information:
Apply liberally 15-minutes before sun exposure.Reapply:- At least every tow-hours.- Immediately after swimming, sweating or towel drying.Sun protection measures. Spending time in the sun increase your risk of skin cancer and early skin aging . To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: - Limit time in the sun, especially between 10am and 2pm.- Wear long sleeve shirts, pants, hats and sunglasses.- For childre under 6-months, consult with a physician.
11-Digit NDC Billing Format:
71355081903
Product Type:
Human Otc Drug
Labeler Name:
Pure Haven Llc
Dosage Form:
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route(s):
  • 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):
  • TITANIUM DIOXIDE 60 mg/mL
  • ZINC OXIDE 60 mg/mL
    • Pharmacologic Class(es):
  • Copper Absorption Inhibitor - [EPC] (Established Pharmacologic Class)
  • Decreased Copper Ion Absorption - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    M020
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    03-28-2017
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 71355-819-03?

    The NDC Packaged Code 71355-819-03 is assigned to a package of 90 ml in 1 tube of Pure Haven Essentials, a human over the counter drug labeled by Pure Haven Llc. The product's dosage form is cream and is administered via topical form.

    Is NDC 71355-819 included in the NDC Directory?

    Yes, Pure Haven Essentials with product code 71355-819 is active and included in the NDC Directory. The product was first marketed by Pure Haven Llc on March 28, 2017 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 71355-819-03?

    The 11-digit format is 71355081903. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-271355-819-035-4-271355-0819-03