Dimenhydrinate
NDC Package 0924-1007-01

11-digit billing NDC: 00924100701
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Dimenhydrinate is to prevemt motion sickness the first dose should be taken ½ to 1 hour before starting activity.To prevent or treat motion sickness:Adults and Children (12 years and older)take 1-2 tablets every 4-6 hours, not more than 8 tablets in 24 hours, or as directed by doctor.Children 6 to under 12 yearsgive 1 tablet every 6-8 hours, not more than 3 tablets in 24 hours or as directed by doctor.Children 2 to under 6 yearsgive ¼ to ½ tablet every 6-8 hours, not more than 1½ tablets in 24 hours or as directed by a doctor. Marketed by Acme United Corporation, this product is identified by NDC 0924-1007 and is authorized under FDA application part336.

Identification & Billing

NDC Package Code
0924-1007-01
Package Description
50 PACKET in 1 CARTON / 2 TABLET in 1 PACKET
Product Code
0924-1007
11-Digit Billing Format
00924100701
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dimenhydrinate
Dosage Form
-
Usage Information
To prevemt motion sickness the first dose should be taken ½ to 1 hour before starting activity.To prevent or treat motion sickness:Adults and Children (12 years and older)take 1-2 tablets every 4-6 hours, not more than 8 tablets in 24 hours, or as directed by doctor.Children 6 to under 12 yearsgive 1 tablet every 6-8 hours, not more than 3 tablets in 24 hours or as directed by doctor.Children 2 to under 6 yearsgive ¼ to ½ tablet every 6-8 hours, not more than 1½ tablets in 24 hours or as directed by a doctor

Regulatory & Marketing

Labeler Name
Acme United Corporation
FDA Application #
part336
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
04-18-2019
Listing Expiration
12-31-2022
Exclude Flag
I
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 (0924-1007). Click a package code to view its specific billing and regulatory data.

0924-1007-02
6 PACKET in 1 BAG / 2 TABLET in 1 PACKET
0924-1007-03
100 TABLET in 1 BOTTLE

* 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 0924-1007-01 identifies a specific commercial package of 50 packet in 1 carton / 2 tablet in 1 packet of Dimenhydrinate, labeled by Acme United Corporation. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Acme United Corporation on April 18, 2019. The current certification is valid through December 31, 2022.

How is this Acme United Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00924100701. 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 (4-4-2)
0924-1007-01
11-Digit CMS (5-4-2)
00924-1007-01

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