Sinus Plus Headache Tablet, Coated
NDC Package 36800-322-05

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

Package Information

Sinus Plus Headache (acetaminophen and phenylephrine hydrochloride) tablets is do not take more than directed (see overdose warning) adults and children 12 years and overtake 2 caplets every 4 hoursswallow whole; do not crush, chew, or dissolvedo not take more than 10 caplets in 24 hourschildren under 12 yearsask a doctor. This formulation utilizes a tablet, coated delivery system. Marketed by Topcare, this product is identified by NDC 36800-322 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
36800-322-05
Package Description
2 BLISTER PACK in 1 CARTON / 12 TABLET, COATED in 1 BLISTER PACK
Product Code
36800-322
11-Digit Billing Format
36800032205
RxNorm Crosswalk
  • RxCUI: 1046378 - acetaminophen 325 MG / phenylephrine HCl 5 MG Oral Tablet
  • RxCUI: 1046378 - acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral Tablet
  • RxCUI: 1046378 - APAP 325 MG / phenylephrine hydrochloride 5 MG Oral Tablet

Clinical Specifications

Proprietary Name
Sinus Plus Headache
Non-Proprietary Name
Acetaminophen And Phenylephrine Hydrochloride
Substance Name
Acetaminophen; Phenylephrine Hydrochloride
Dosage Form
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with 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 directed (see overdose warning) adults and children 12 years and overtake 2 caplets every 4 hoursswallow whole; do not crush, chew, or dissolvedo not take more than 10 caplets in 24 hourschildren under 12 yearsask a doctor

Regulatory & Marketing

Labeler Name
Topcare
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-01-2020
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 36800-322-05 identifies a specific commercial package of 2 blister pack in 1 carton / 12 tablet, coated in 1 blister pack of Sinus Plus Headache, a human over the counter drug labeled by Topcare. This tablet, coated is formulated for oral use and contains acetaminophen; 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 Topcare on July 01, 2020. The current certification is valid through December 31, 2026.

How is this Topcare product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36800032205. 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)
36800-322-05
11-Digit CMS (5-4-2)
36800-0322-05

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