Domeboro Powder, For Solution
NDC Package 16864-240-01

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

Domeboro (aluminum sulfate tetradecahydrate, calcium acetate monohydrate) powders is dissolve 1 to 3 packets in a pint (16 oz) of cool or warm waterstir until fully dissolved; do not strain or filter. This formulation utilizes a powder, for solution delivery system. Marketed by Advantice Health, Llc., this product is identified by NDC 16864-240 and is authorized under FDA application M016.

Identification & Billing

NDC Package Code
16864-240-01
Package Description
12 POWDER, FOR SOLUTION in 1 BOX
Product Code
16864-240
11-Digit Billing Format
16864024001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
12 EA
RxNorm Crosswalk
  • RxCUI: 1250234 - aluminum sulfate 1347 MG / calcium acetate 952 MG in 160 ML Topical Solution
  • RxCUI: 1250234 - aluminum sulfate 8.42 MG/ML / calcium acetate 5.95 MG/ML Topical Solution
  • RxCUI: 1250234 - (3 Packets (aluminum sulfate 1347 MG Powder / calcium acetate 952 MG Powder)) per 16 OZ Topical Solution
  • RxCUI: 1250234 - aluminum sulfate 1347 MG / calcium acetate 952 MG per 160 ML Topical Solution
  • RxCUI: 1293268 - Domeboro (aluminum sulfate 1347 MG / calcium acetate 952 MG) per 16 OZ Powder for Topical Solution

Clinical Specifications

Proprietary Name
Domeboro
Non-Proprietary Name
Aluminum Sulfate Tetradecahydrate, Calcium Acetate Monohydrate
Substance Name
Aluminum Sulfate Tetradecahydrate; Calcium Acetate Monohydrate
Dosage Form
Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
Usage Information
Dissolve 1 to 3 packets in a pint (16 oz) of cool or warm waterstir until fully dissolved; do not strain or filter. The resulting mixture contains 0.16% (1 packet), 0.32% (2 packets), or 0.48% (3 packets) aluminum acetate and is ready for use.              For use as a soak:soak affected area for 15 to 30 minutes as needed, or as directed by a doctorrepeat 3 times a day or as directed by a doctordiscard solution after each useFor use as a compress or wet dressing:soak a clean, soft cloth in the solutionapply cloth loosely to affected area for 15 to 30 minutesrepeat as needed or as directed by a doctordiscard solution after each use

Regulatory & Marketing

Labeler Name
Advantice Health, Llc.
Product Type
Human Otc Drug
FDA Application #
M016
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-26-2012
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 (16864-240). Click a package code to view its specific billing and regulatory data.

16864-240-10
100 POWDER, FOR SOLUTION in 1 BOX
16864-240-14
14 POWDER, FOR SOLUTION in 1 BOX

* 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 16864-240-01 identifies a specific commercial package of 12 powder, for solution in 1 box of Domeboro, a human over the counter drug labeled by Advantice Health, Llc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 12 billable units per package. This powder, for solution is formulated for topical use and contains aluminum sulfate tetradecahydrate; calcium acetate monohydrate 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 Advantice Health, Llc. on June 26, 2012. The current certification is valid through December 31, 2026.

How is this Advantice Health, Llc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16864024001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 12 total billable units per package. 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)
16864-240-01
11-Digit CMS (5-4-2)
16864-0240-01

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