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  5. NDC Package Code: 68016-631-00 Diphenhydramine Hcl And Zinc Acetate

NDC Package 68016-631-00 Diphenhydramine Hcl And Zinc Acetate

Allergy Relief Spray Aerosol, Spray 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:
68016-631-00
Package Description:
76 g in 1 CAN
Product Code:
68016-631
Proprietary Name:
Diphenhydramine Hcl And Zinc Acetate
Non-Proprietary Name:
Allergy Relief Spray
Substance Name:
Diphenhydramine Hydrochloride; Zinc Acetate
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: ask a doctor
11-Digit NDC Billing Format:
68016063100
NDC to RxNorm Crosswalk:
  • RxCUI: 1053138 - diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical Spray
  • RxCUI: 1053138 - diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical Spray
  • RxCUI: 1053138 - diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical Spray
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Chain Drug Consortium, Llc
    Dosage Form:
    Aerosol, Spray - An aerosol product which utilizes a compressed gas as the propellant to provide the force necessary to expel the product as a wet spray; it is applicable to solutions of medicinal agents in aqueous solvents.
    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):
  • DIPHENHYDRAMINE HYDROCHLORIDE 1.52 g/76g
  • ZINC ACETATE .076 g/76g
    • 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:
    12-10-2010
    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 68016-631-00?

    The NDC Packaged Code 68016-631-00 is assigned to a package of 76 g in 1 can of Diphenhydramine Hcl And Zinc Acetate, a human over the counter drug labeled by Chain Drug Consortium, Llc. The product's dosage form is aerosol, spray and is administered via topical form.

    Is NDC 68016-631 included in the NDC Directory?

    Yes, Diphenhydramine Hcl And Zinc Acetate with product code 68016-631 is active and included in the NDC Directory. The product was first marketed by Chain Drug Consortium, Llc on December 10, 2010 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 68016-631-00?

    The 11-digit format is 68016063100. 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
    5-3-268016-631-005-4-268016-0631-00