Non-drowsy Daytime Severe Cold Multi-symptom
NDC Package 68210-4166-1

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Non-drowsy Daytime Severe Cold Multi-symptom is do not take more than directedadults and children 12 years and over take 2 caplets every 4 hoursswallow whole - do not crush, chew, or dissolvedo not take more than 10 caplets in 24 hourschildren under 12 years: ask a doctor. Marketed by Spirit Pharmaceuticals Llc, this product is identified by NDC 68210-4166 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
68210-4166-1
Package Description
1 BOTTLE in 1 CARTON / 12 TABLET, FILM COATED in 1 BOTTLE
Product Code
68210-4166
11-Digit Billing Format
68210416601
RxNorm Crosswalk
  • RxCUI: 1110988 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet
  • RxCUI: 1110988 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet
  • RxCUI: 1110988 - APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet

Clinical Specifications

Proprietary Name
Non-drowsy Daytime Severe Cold Multi-symptom
Dosage Form
-
Usage Information
Do not take more than directedadults and children 12 years and over take 2 caplets every 4 hoursswallow whole - do not crush, chew, or dissolvedo not take more than 10 caplets in 24 hourschildren under 12 years: ask a doctor

Regulatory & Marketing

Labeler Name
Spirit Pharmaceuticals Llc
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-29-2021
Listing Expiration
12-31-2025
Exclude Flag
I
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 68210-4166-1 identifies a specific commercial package of 1 bottle in 1 carton / 12 tablet, film coated in 1 bottle of Non-drowsy Daytime Severe Cold Multi-symptom, labeled by Spirit Pharmaceuticals Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Spirit Pharmaceuticals Llc on June 29, 2021. The current certification is valid through December 31, 2025.

How is this Spirit Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68210416601. 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 (5-4-1)
68210-4166-1
11-Digit CMS (5-4-2)
68210-4166-01

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