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  5. NDC Package Code: 53942-515-25 Cold And Sinus Maxium Strength

NDC Package 53942-515-25 Cold And Sinus Maxium Strength

Acetaminophen,Guaifenesin,Phenylephrine Hydrochloride Liquid 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:
53942-515-25
Package Description:
177 mL in 1 BOTTLE
Product Code:
53942-515
Proprietary Name:
Cold And Sinus Maxium Strength
Non-Proprietary Name:
Acetaminophen, Guaifenesin, Phenylephrine Hydrochloride
Substance Name:
Acetaminophen; Guaifenesin; Phenylephrine Hydrochloride
Usage Information:
Take only as recommended (see Overdose warning)use dosage cupmL = milliliterdo not take more han 6 doses in any 24-hour periodAge                                                  DoseAdults & children                               20 mL every 4 hours12 years and olderChildren under 12                             Do not useyears of age
11-Digit NDC Billing Format:
53942051525
NDC to RxNorm Crosswalk:
  • RxCUI: 1116568 - acetaminophen 650 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution
  • RxCUI: 1116568 - acetaminophen 32.5 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution
  • RxCUI: 1116568 - acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution
  • RxCUI: 1116568 - acetaminophen 650 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution
  • RxCUI: 1116568 - APAP 32.5 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Demoulas Market Basket
    Dosage Form:
    Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ACETAMINOPHEN 650 mg/20mL
  • GUAIFENESIN 400 mg/20mL
  • PHENYLEPHRINE HYDROCHLORIDE 10 mg/20mL
    • 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)
  • alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    M012
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    09-19-2013
    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.

    Frequently Asked Questions

    What is NDC 53942-515-25?

    The NDC Packaged Code 53942-515-25 is assigned to a package of 177 ml in 1 bottle of Cold And Sinus Maxium Strength, a human over the counter drug labeled by Demoulas Market Basket. The product's dosage form is liquid and is administered via oral form.

    Is NDC 53942-515 included in the NDC Directory?

    Yes, Cold And Sinus Maxium Strength with product code 53942-515 is active and included in the NDC Directory. The product was first marketed by Demoulas Market Basket on September 19, 2013 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 53942-515-25?

    The 11-digit format is 53942051525. 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
    5-3-253942-515-255-4-253942-0515-25