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  5. NDC Package Code: 65753-400-14 Coretex Anti-itch Gel

NDC Package 65753-400-14 Coretex Anti-itch Gel

Camphor,Diphenhydramine,Zinc Acetate Gel Topical - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
65753-400-14
Package Description:
300 POUCH in 1 CONTAINER / 1 mL in 1 POUCH
Product Code:
65753-400
Proprietary Name:
Coretex Anti-itch Gel
Non-Proprietary Name:
Camphor, Diphenhydramine, Zinc Acetate
Substance Name:
Camphor (synthetic); Diphenhydramine Hydrochloride; Zinc Acetate
Usage Information:
Adults and children 12 years of age and older, apply to affected area not more than 3 to 4 times daily, or as directed bu a doctor.
11-Digit NDC Billing Format:
65753040014
NDC to RxNorm Crosswalk:
  • RxCUI: 2263170 - camphor 0.1 % / diphenhydrAMINE HCl 2 % / zinc acetate 1 % Topical Gel
  • RxCUI: 2263170 - camphor 0.001 MG/MG / diphenhydramine hydrochloride 0.02 MG/MG / zinc acetate 0.01 MG/MG Topical Gel
  • RxCUI: 2263170 - camphor 0.001 MG/MG / diphenhydramine HCl 0.02 MG/MG / zinc acetate 0.01 MG/MG Topical Gel
  • RxCUI: 2263170 - camphor 0.1 % / diphenhydramine HCl 2 % / zinc acetate 1 % Topical Gel
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Coretex Products Inc
    Dosage Form:
    Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
    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):
  • CAMPHOR (SYNTHETIC) .1 g/100mL
  • DIPHENHYDRAMINE HYDROCHLORIDE 2 g/100mL
  • ZINC ACETATE 1 g/100mL
    • Pharmacologic Class(es):
  • Copper Absorption Inhibitor - [EPC] (Established Pharmacologic Class)
  • Decreased Copper Ion Absorption - [PE] (Physiologic Effect)
  • Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    M017
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    11-25-2019
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    65753-400-0259 mL in 1 BOTTLE
    65753-400-04177 mL in 1 BOTTLE
    65753-400-1325 POUCH in 1 CONTAINER / 1 mL in 1 POUCH

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 65753-400-14?

    The NDC Packaged Code 65753-400-14 is assigned to a package of 300 pouch in 1 container / 1 ml in 1 pouch of Coretex Anti-itch Gel, a human over the counter drug labeled by Coretex Products Inc. The product's dosage form is gel and is administered via topical form.

    Is NDC 65753-400 included in the NDC Directory?

    Yes, Coretex Anti-itch Gel with product code 65753-400 is active and included in the NDC Directory. The product was first marketed by Coretex Products Inc on November 25, 2019 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 65753-400-14?

    The 11-digit format is 65753040014. 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
    5-3-265753-400-145-4-265753-0400-14