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  5. NDC Package Code: 53345-025-01 Daytime Cold And Flu

NDC Package 53345-025-01 Daytime Cold And Flu

Acetaminophen,Dextromethorphan Hydrobromide,Phenylephrine Hydrochloride Capsule, Liquid - 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:
53345-025-01
Package Description:
1 BAG in 1 BOX / 4000 CAPSULE, LIQUID FILLED in 1 BAG
Product Code:
53345-025
Proprietary Name:
Daytime Cold And Flu
Non-Proprietary Name:
Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Substance Name:
Acetaminophen; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride
Usage Information:
Take only as directed - see Overdose warningdo not exceed 4 doses per 24 hoursadults and children 12 years of age and older take 2 softgels with water every 4 hourschildren 4 to under 12 years of age ask a doctorchildren under 4 years of age do not useWhen using other Nighttime or Daytime products, carefully read each label to ensure correct dosing.
11-Digit NDC Billing Format:
53345002501
NDC to RxNorm Crosswalk:
  • RxCUI: 1086997 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule
  • RxCUI: 1086997 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule
  • RxCUI: 1086997 - APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Humanwell Puracap Pharmaceutical (wuhan), Ltd.
    Dosage Form:
    Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ACETAMINOPHEN 325 mg/1
  • DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1
  • PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
    • Pharmacologic Class(es):
  • Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
  • 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:
    08-11-2014
    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 53345-025-01?

    The NDC Packaged Code 53345-025-01 is assigned to a package of 1 bag in 1 box / 4000 capsule, liquid filled in 1 bag of Daytime Cold And Flu, a human over the counter drug labeled by Humanwell Puracap Pharmaceutical (wuhan), Ltd.. The product's dosage form is capsule, liquid filled and is administered via oral form.

    Is NDC 53345-025 included in the NDC Directory?

    Yes, Daytime Cold And Flu with product code 53345-025 is active and included in the NDC Directory. The product was first marketed by Humanwell Puracap Pharmaceutical (wuhan), Ltd. on August 11, 2014 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 53345-025-01?

    The 11-digit format is 53345002501. 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
    5-3-253345-025-015-4-253345-0025-01