Topcare Nasal Four Spray
NDC Package 36800-648-10

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

Package Information

Topcare Nasal Four (phenylephrine hydrochloride) sprays is •adults and children 12 years and over: 2 or 3 sprays in each nostril not more often than every 4 hours •children under 12 years: ask a doctorUse instructions: with head in a normal, upright position, put atomizer tip into nostril. This formulation utilizes a spray delivery system. Marketed by Topco Associates Llc, this product is identified by NDC 36800-648 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
36800-648-10
Package Description
1 BOTTLE, SPRAY in 1 CARTON / 30 mL in 1 BOTTLE, SPRAY
Product Code
36800-648
11-Digit Billing Format
36800064810
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Topcare Nasal Four
Non-Proprietary Name
Phenylephrine Hydrochloride
Substance Name
Phenylephrine Hydrochloride
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
Administration Route
Nasal - Administration to the nose; administered by way of the nose.
Active Ingredient(s)
PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL
Pharmacologic Class
Usage Information
•adults and children 12 years and over: 2 or 3 sprays in each nostril not more often than every 4 hours •children under 12 years: ask a doctorUse instructions: with head in a normal, upright position, put atomizer tip into nostril. Squeeze bottle with firm, quick pressure while inhaling. Wipe nozzle clean after each use.

Regulatory & Marketing

Labeler Name
Topco Associates Llc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-10-2002
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 36800-648-10 identifies a specific commercial package of 1 bottle, spray in 1 carton / 30 ml in 1 bottle, spray of Topcare Nasal Four, a human over the counter drug labeled by Topco Associates Llc. This spray is formulated for nasal use and contains 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 Topco Associates Llc on December 10, 2002. The current certification is valid through December 31, 2026.

How is this Topco Associates Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36800064810. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
36800-648-10
11-Digit CMS (5-4-2)
36800-0648-10

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