Night Cold Flu Cough And Allergy Capsule, Liquid Filled
NDC Package 53345-020-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Night Cold Flu Cough And Allergy (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride) capsules is do not take more than the recommended doseadults and children 12 years of age and over: take 2 softgels with water every 4 hours. This formulation utilizes a capsule, liquid filled delivery system. Marketed by Humanwell Puracap Pharmaceutical (wuhan), Ltd., this product is identified by NDC 53345-020 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
53345-020-01
Package Description
1 BAG in 1 BOX / 4000 CAPSULE, LIQUID FILLED in 1 BAG
Product Code
53345-020
11-Digit Billing Format
53345002001
RxNorm Crosswalk
  • RxCUI: 1297288 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule
  • RxCUI: 1297288 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule
  • RxCUI: 1297288 - APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule

Clinical Specifications

Proprietary Name
Night Cold Flu Cough And Allergy
Non-Proprietary Name
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
Substance Name
Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate; Phenylephrine Hydrochloride
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Do not take more than the recommended doseadults and children 12 years of age 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 of age: do not use

Regulatory & Marketing

Labeler Name
Humanwell Puracap Pharmaceutical (wuhan), Ltd.
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-29-2013
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 53345-020-01 identifies a specific commercial package of 1 bag in 1 box / 4000 capsule, liquid filled in 1 bag of Night Cold Flu Cough And Allergy, a human over the counter drug labeled by Humanwell Puracap Pharmaceutical (wuhan), Ltd.. This capsule, liquid filled is formulated for oral use and contains acetaminophen; dextromethorphan hydrobromide; doxylamine succinate; phenylephrine hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Humanwell Puracap Pharmaceutical (wuhan), Ltd. on May 29, 2013. The current certification is valid through December 31, 2026.

How is this Humanwell Puracap Pharmaceutical (wuhan), Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53345002001. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
53345-020-01
11-Digit CMS (5-4-2)
53345-0020-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.