NDC Package 82765-0043-0 Denticalm

Topical Analgesic Emulsion Topical - View Billable Units, 11-Digit Format, RxNorm

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:
82765-0043-0
Package Description:
1 PACKAGE in 1 PACKAGE / .47 mL in 1 PACKAGE (82765-0043-1)
Product Code:
Proprietary Name:
Denticalm
Non-Proprietary Name:
Topical Analgesic
Substance Name:
Menthol
Usage Information:
Shake before use. Adults and children 12 years of age and older: apply over affected areas not more than four times daily; massage as necessary. Children under 12 years of age: Consult physician.
11-Digit NDC Billing Format:
82765004300
Product Type:
Human Otc Drug
Labeler Name:
Nfuse Llc
Dosage Form:
Emulsion - A dosage form consisting of a two-phase system comprised of at least two immiscible liquids1, one of which is dispersed as droplets (internal or dispersed phase) within the other liquid (external or continuous phase), generally stabilized with one or more emulsifying agents. (Note: Emulsion is used as a dosage form term unless a more specific term is applicable, e.g. cream, lotion, ointment.)
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):
    Sample Package:
    No
    FDA Application Number:
    M017
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    02-01-2024
    Listing Expiration Date:
    12-31-2025
    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 82765-0043-0?

    The NDC Packaged Code 82765-0043-0 is assigned to a package of 1 package in 1 package / .47 ml in 1 package (82765-0043-1) of Denticalm, a human over the counter drug labeled by Nfuse Llc. The product's dosage form is emulsion and is administered via topical form.

    Is NDC 82765-0043 included in the NDC Directory?

    Yes, Denticalm with product code 82765-0043 is active and included in the NDC Directory. The product was first marketed by Nfuse Llc on February 01, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 82765-0043-0?

    The 11-digit format is 82765004300. 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 5-4-1 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
    5-4-182765-0043-05-4-282765-0043-00