1. Home
  2. Labeler Index
  3. Humanwell Puracap Pharmaceutical (wuhan) Co., Ltd
  4. 53345-045
  5. NDC Package Code: 53345-045-01 Cough And Cold Plus

NDC Package 53345-045-01 Cough And Cold Plus

Acetaminophen,Phenylephrine Hcl,Chlorpheniramine Maleate,Dextromethorphan Hbr Capsule, - 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:
53345-045-01
Package Description:
1 BAG in 1 BOX / 4000 CAPSULE, LIQUID FILLED in 1 BAG
Product Code:
53345-045
Proprietary Name:
Cough And Cold Plus
Non-Proprietary Name:
Acetaminophen, Phenylephrine Hcl, Chlorpheniramine Maleate, Dextromethorphan Hbr
Substance Name:
Acetaminophen; Chlorpheniramine Maleate; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride
Usage Information:
Do not take more than the recommended doseadults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.children under 12 years: do not use
11-Digit NDC Billing Format:
53345004501
NDC to RxNorm Crosswalk:
  • RxCUI: 1042688 - acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule
  • RxCUI: 1042688 - acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule
  • RxCUI: 1042688 - APAP 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Humanwell Puracap Pharmaceutical (wuhan) Co., 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
  • CHLORPHENIRAMINE MALEATE 2 mg/1
  • DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1
  • PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
    • Pharmacologic Class(es):
  • Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
  • Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • 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:
    03-24-2017
    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 53345-045-01?

    The NDC Packaged Code 53345-045-01 is assigned to a package of 1 bag in 1 box / 4000 capsule, liquid filled in 1 bag of Cough And Cold Plus, a human over the counter drug labeled by Humanwell Puracap Pharmaceutical (wuhan) Co., Ltd. The product's dosage form is capsule, liquid filled and is administered via oral form.

    Is NDC 53345-045 included in the NDC Directory?

    Yes, Cough And Cold Plus with product code 53345-045 is active and included in the NDC Directory. The product was first marketed by Humanwell Puracap Pharmaceutical (wuhan) Co., Ltd on March 24, 2017 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 53345-045-01?

    The 11-digit format is 53345004501. 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
    5-3-253345-045-015-4-253345-0045-01