Maximum Strength Cold Tabs Capsule, Coated
NDC Package 73598-1342-1

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

Package Information

Maximum Strength Cold Tabs (acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride) capsules is do not take more than directedadults and children 12 years and over: take 2 caplets every 4 hoursdo not to take more than 10 caplets in 24 hourschildren under 12 years: ask a doctor. This formulation utilizes a capsule, coated delivery system. Marketed by Jhk Dba American Safety & First Aid, this product is identified by NDC 73598-1342 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
73598-1342-1
Package Description
40 PACKET in 1 BOX / 2 CAPSULE, COATED in 1 PACKET
Product Code
73598-1342
11-Digit Billing Format
73598134201

Clinical Specifications

Proprietary Name
Maximum Strength Cold Tabs
Non-Proprietary Name
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride
Substance Name
Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride
Dosage Form
Capsule, Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; additionally, the capsule is covered in a designated coating.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Do not take more than directedadults and children 12 years and over: take 2 caplets every 4 hoursdo not to take more than 10 caplets in 24 hourschildren under 12 years: ask a doctor

Regulatory & Marketing

Labeler Name
Jhk Dba American Safety & First Aid
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-26-2024
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 73598-1342-1 identifies a specific commercial package of 40 packet in 1 box / 2 capsule, coated in 1 packet of Maximum Strength Cold Tabs, a human over the counter drug labeled by Jhk Dba American Safety & First Aid. This capsule, coated 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 Jhk Dba American Safety & First Aid on June 26, 2024. The current certification is valid through December 31, 2026.

How is this Jhk Dba American Safety & First Aid product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 73598134201. 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)
73598-1342-1
11-Digit CMS (5-4-2)
73598-1342-01

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