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  5. NDC Package Code: 63868-670-16 Mucus Relief Severe Congestion And Sinus

NDC Package 63868-670-16 Mucus Relief Severe Congestion And Sinus

Acetaminophen,Dextromethorphan Hbr,Guaifenesin,Phenylephrine Hcl Capsule 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:
63868-670-16
Package Description:
16 BLISTER PACK in 1 CARTON / 1 CAPSULE in 1 BLISTER PACK
Product Code:
63868-670
Proprietary Name:
Mucus Relief Severe Congestion And Sinus
Non-Proprietary Name:
Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
Substance Name:
Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride
Usage Information:
Do not take more than directed (see Overdose warning)do not take more than 12 softgels in any 24-hour periodadults and children 12 years and older: take 2 softgels every 4 hourschildren under 12 years of age: do not use
11-Digit NDC Billing Format:
63868067016
NDC to RxNorm Crosswalk:
  • RxCUI: 1656815 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule
  • RxCUI: 1656815 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule
  • RxCUI: 1656815 - APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Quality Choice (chain Drug Marketing Association)
    Dosage Form:
    Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
    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 200 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:
    part341
    Marketing Category:
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date:
    06-30-2019
    End Marketing Date:
    06-30-2025
    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 63868-670-16?

    The NDC Packaged Code 63868-670-16 is assigned to a package of 16 blister pack in 1 carton / 1 capsule in 1 blister pack of Mucus Relief Severe Congestion And Sinus, a human over the counter drug labeled by Quality Choice (chain Drug Marketing Association). The product's dosage form is capsule and is administered via oral form.

    Is NDC 63868-670 included in the NDC Directory?

    Yes, Mucus Relief Severe Congestion And Sinus with product code 63868-670 is active and included in the NDC Directory. The product was first marketed by Quality Choice (chain Drug Marketing Association) on June 30, 2019.

    What is the 11-digit format for NDC 63868-670-16?

    The 11-digit format is 63868067016. 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
    5-3-263868-670-165-4-263868-0670-16