Antibacterial Dreamy Florals Soap
NDC Package 83033-0010-1

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

Package Information

Antibacterial Dreamy Florals (glycerin) soaps is a medication used to relieve occasional constipation. This formulation utilizes a soap delivery system. Marketed by Quimicas Handal De Centroamerica Sa De Cv, this product is identified by NDC 83033-0010 and is authorized under FDA application M016.

Identification & Billing

NDC Package Code
83033-0010-1
Package Description
300 g in 1 BOTTLE, WITH APPLICATOR
Product Code
83033-0010
11-Digit Billing Format
83033001001

Clinical Specifications

Proprietary Name
Antibacterial Dreamy Florals
Non-Proprietary Name
Glycerin
Substance Name
Glycerin
Dosage Form
Soap - Any compound of one or more fatty acids, or their equivalents, with an alkali; soap is detergent and is much employed in liniments, enemas, and in making pills. It is also a mild aperient, antacid and antiseptic.
Administration Route
Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
Active Ingredient(s)
GLYCERIN 1 g/g
Pharmacologic Class
Usage Information
This product is used to relieve occasional constipation. Glycerin belongs to a class of drugs known as hyperosmotic laxatives. It works by drawing water into the intestines. This effect usually results in a bowel movement within 15 to 60 minutes. For adults, the normal frequency of bowel movements varies from once daily to 1 to 2 times weekly. For preschool-aged children, the normal frequency of bowel movements varies from once daily to once every other day. Constipation is best treated by drinking plenty of fluids, eating foods high in fiber, and exercising regularly.

Regulatory & Marketing

Labeler Name
Quimicas Handal De Centroamerica Sa De Cv
Product Type
Human Otc Drug
FDA Application #
M016
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-11-2022
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 83033-0010-1 identifies a specific commercial package of 300 g in 1 bottle, with applicator of Antibacterial Dreamy Florals, a human over the counter drug labeled by Quimicas Handal De Centroamerica Sa De Cv. This soap is formulated for transdermal use and contains glycerin 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 Quimicas Handal De Centroamerica Sa De Cv on November 11, 2022. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This product is used to relieve occasional constipation. Glycerin belongs to a class of drugs known as hyperosmotic laxatives. It works by drawing water into the intestines. This effect usually results in a bowel movement within 15 to 60 minutes. For adults, the normal frequency of bowel movements varies from once daily to 1 to 2 times weekly. For preschool-aged children, the normal frequency of bowel movements varies from once daily to once every other day. Constipation is best treated by drinking plenty of fluids, eating foods high in fiber, and exercising regularly.

How is this Quimicas Handal De Centroamerica Sa De Cv product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83033001001. 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 (5-4-1)
83033-0010-1
11-Digit CMS (5-4-2)
83033-0010-01

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