Topcare Nasal Spray, Metered
NDC Package 36800-907-10

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

Package Information

Topcare Nasal (oxymetazoline hydrochloride) sprays is •adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. This formulation utilizes a spray, metered delivery system. Marketed by Topco Associates Llc, this product is identified by NDC 36800-907 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
36800-907-10
Package Description
1 BOTTLE, SPRAY in 1 CARTON / 30 mL in 1 BOTTLE, SPRAY
Product Code
36800-907
11-Digit Billing Format
36800090710
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Topcare Nasal
Non-Proprietary Name
Oxymetazoline Hydrochloride
Substance Name
Oxymetazoline Hydrochloride
Dosage Form
Spray, Metered - A non-pressurized dosage form consisting of valves which allow the dispensing of a specified quantity of spray upon each activation.
Administration Route
Nasal - Administration to the nose; administered by way of the nose.
Active Ingredient(s)
OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL
Pharmacologic Class
Usage Information
•adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.•children under 6 years of age: ask a doctorShake well before use. Before using the first time, unlock pump, remove the protective cap from the tip and prime metered pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use. Lock pump to maintain child resistance.

Regulatory & Marketing

Labeler Name
Topco Associates Llc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-14-2016
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 36800-907-10 identifies a specific commercial package of 1 bottle, spray in 1 carton / 30 ml in 1 bottle, spray of Topcare Nasal, a human over the counter drug labeled by Topco Associates Llc. This spray, metered is formulated for nasal use and contains oxymetazoline 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 July 14, 2016. 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: 36800090710. 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)
36800-907-10
11-Digit CMS (5-4-2)
36800-0907-10

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