Daytime Severe Cold And Flu Capsule, Liquid Filled
NDC Package 53345-021-01

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

Package Information

Daytime Severe Cold And Flu (acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride) capsules is take only as directed - see  Overdose warningdo not exceed 4 doses per 24 hoursadults & children 12 years of age and over2 softgels with water every 4 hourschildren 4 to under 12 years of ageask a doctorchildren under 4 years of agedo not usewhen using other Nighttime or Daytime products, carefully read each label to ensure correct dosing. This formulation utilizes a capsule, liquid filled delivery system. Marketed by Humanwell Puracap Pharmaceutical (wuhan), Ltd., this product is identified by NDC 53345-021 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
53345-021-01
Package Description
1 BAG in 1 BOX / 3000 CAPSULE, LIQUID FILLED in 1 BAG
Product Code
53345-021
11-Digit Billing Format
53345002101
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

Clinical Specifications

Proprietary Name
Daytime Severe Cold And Flu
Non-Proprietary Name
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
Substance Name
Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; 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
Take only as directed - see  Overdose warningdo not exceed 4 doses per 24 hoursadults & children 12 years of age and over2 softgels with water every 4 hourschildren 4 to under 12 years of ageask a doctorchildren under 4 years of agedo not usewhen using other Nighttime or Daytime products, carefully read each label to ensure correct dosing

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
07-11-2014
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 53345-021-01 identifies a specific commercial package of 1 bag in 1 box / 3000 capsule, liquid filled in 1 bag of Daytime Severe Cold And Flu, 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; guaifenesin; 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 July 11, 2014. 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: 53345002101. 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)
53345-021-01
11-Digit CMS (5-4-2)
53345-0021-01

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