Dristan Spray
NDC Package 80070-400-05

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

Package Information

Dristan (oxymetazoline hydrochloride) sprays is adults and children 6 to under 12 years of age (with adult supervision): 2 to 3 sprays in each nostril not more often than every 10 to 12 hours. This formulation utilizes a spray delivery system. Marketed by Foundation Consumer Brands, this product is identified by NDC 80070-400 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
80070-400-05
Package Description
1 BOTTLE, SPRAY in 1 CARTON / 15 mL in 1 BOTTLE, SPRAY
Product Code
80070-400
11-Digit Billing Format
80070040005
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dristan 12 Hr
Non-Proprietary Name
Oxymetazoline Hydrochloride
Substance Name
Oxymetazoline 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)
OXYMETAZOLINE HYDROCHLORIDE .5 mg/mL
Pharmacologic Class
Usage Information
Adults and children 6 to under 12 years of age (with adult supervision): 2 to 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 doctor To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Replace cap tightly to maintain child resistant closure.

Regulatory & Marketing

Labeler Name
Foundation Consumer Brands
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-17-2021
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (80070-400). Click a package code to view its specific billing and regulatory data.

80070-400-15
45 mL in 1 CARTON

* 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 80070-400-05 identifies a specific commercial package of 1 bottle, spray in 1 carton / 15 ml in 1 bottle, spray of Dristan 12 Hr, a human over the counter drug labeled by Foundation Consumer Brands. This spray 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 Foundation Consumer Brands on August 17, 2021. The current certification is valid through December 31, 2026.

How is this Foundation Consumer Brands product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80070040005. 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)
80070-400-05
11-Digit CMS (5-4-2)
80070-0400-05

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