Baczol Cold Medicine Syrup
NDC Package 76864-208-01

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

Package Information

Baczol Cold Medicine (acetaminophen, dextromethorphan hbr, chlorpheniramine maleate, phenylephrine hcl) syrups is uses • Temporarily relieves runny nose, sneezing, itching ofthe nose or throat, and itchy, watery eyes due to hay fever • nasalcongestion due to the common cold • Calms the cough controlcenter and relieves coughing • minor aches and pains associatedwith the common cold • temporarily reduces fever. This formulation utilizes a syrup delivery system. Marketed by Procaps S.a. De C.v., this product is identified by NDC 76864-208 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
76864-208-01
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 120 mL in 1 BOTTLE, PLASTIC
Product Code
76864-208
11-Digit Billing Format
76864020801
RxNorm Crosswalk
  • RxCUI: 1370440 - acetaminophen 250 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 10 MG in 5 mL Oral Solution
  • RxCUI: 1370440 - acetaminophen 50 MG/ML / chlorpheniramine maleate 0.8 MG/ML / dextromethorphan hydrobromide 2 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral Solution
  • RxCUI: 1370440 - acetaminophen 250 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 10 per 5 ML Oral Solution
  • RxCUI: 1370440 - APAP 50 MG/ML / Chlorpheniramine Maleate 0.8 MG/ML / Dextromethorphan Hydrobromide 2 MG/ML / Phenylephrine Hydrochloride 2 MG/ML Oral Solution

Clinical Specifications

Proprietary Name
Baczol Cold Medicine
Non-Proprietary Name
Acetaminophen, Dextromethorphan Hbr, Chlorpheniramine Maleate, Phenylephrine Hcl
Substance Name
Acetaminophen; Chlorpheniramine Maleate; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride
Dosage Form
Syrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Uses • Temporarily relieves runny nose, sneezing, itching ofthe nose or throat, and itchy, watery eyes due to hay fever • nasalcongestion due to the common cold • Calms the cough controlcenter and relieves coughing • minor aches and pains associatedwith the common cold • temporarily reduces fever.

Regulatory & Marketing

Labeler Name
Procaps S.a. De C.v.
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-25-2020
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 76864-208-01 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 120 ml in 1 bottle, plastic of Baczol Cold Medicine, a human over the counter drug labeled by Procaps S.a. De C.v.. This syrup is formulated for oral use and contains acetaminophen; chlorpheniramine maleate; dextromethorphan hydrobromide; 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 Procaps S.a. De C.v. on May 25, 2020. The current certification is valid through December 31, 2026.

How is this Procaps S.a. De C.v. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76864020801. 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)
76864-208-01
11-Digit CMS (5-4-2)
76864-0208-01

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