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  5. NDC Package Code: 49314-4358-0 Unishield Cough And Cold

NDC Package 49314-4358-0 Unishield Cough And Cold

Acetaminophen,Dextromethorphan Hbr,Phenylephrine Hcl ,Guaifenesin Tablet, Film Coated Oral - 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:
49314-4358-0
Package Description:
40 PACKET in 1 BOX / 2 TABLET, FILM COATED in 1 PACKET
Product Code:
49314-4358
Proprietary Name:
Unishield Cough And Cold
Non-Proprietary Name:
Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl , Guaifenesin
Substance Name:
Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride
Usage Information:
Uses Temporarily relieves these symptoms due to the common cold: ■ headache ■ nasal congestion ■ cough ■ minor aches and pains ■ sore throat ■ sinus congestion and pressure ■ helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive Temporarily reduces fever.
11-Digit NDC Billing Format:
49314435800
NDC to RxNorm Crosswalk:
  • RxCUI: 1098435 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 100 MG / phenylephrine HCl 5 MG Oral Tablet
  • RxCUI: 1098435 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG / phenylephrine hydrochloride 5 MG Oral Tablet
  • RxCUI: 1098435 - APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 100 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Unishield
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ACETAMINOPHEN 325 mg/1
  • DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1
  • GUAIFENESIN 100 mg/1
  • PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
    • Pharmacologic Class(es):
  • Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
  • Decreased Respiratory Secretion Viscosity - [PE] (Physiologic Effect)
  • Expectorant - [EPC] (Established Pharmacologic Class)
  • Increased Respiratory Secretions - [PE] (Physiologic Effect)
  • Sigma-1 Agonist - [EPC] (Established Pharmacologic Class)
  • Sigma-1 Receptor Agonists - [MoA] (Mechanism of Action)
  • Uncompetitive N-methyl-D-aspartate Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Uncompetitive NMDA Receptor Antagonists - [MoA] (Mechanism of Action)
  • alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    M012
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    09-26-2022
    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 49314-4358-0?

    The NDC Packaged Code 49314-4358-0 is assigned to a package of 40 packet in 1 box / 2 tablet, film coated in 1 packet of Unishield Cough And Cold, a human over the counter drug labeled by Unishield. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 49314-4358 included in the NDC Directory?

    Yes, Unishield Cough And Cold with product code 49314-4358 is active and included in the NDC Directory. The product was first marketed by Unishield on September 26, 2022 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 49314-4358-0?

    The 11-digit format is 49314435800. 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
    5-4-149314-4358-05-4-249314-4358-00