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  5. NDC Package Code: 69396-127-03 Hydro Gel

NDC Package 69396-127-03 Hydro Gel

Glycerin 20% Gel Topical - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
69396-127-03
Package Description:
1 TUBE in 1 BOX / 84.7 g in 1 TUBE
Product Code:
69396-127
Proprietary Name:
Hydro Gel
Non-Proprietary Name:
Glycerin 20%
Substance Name:
Glycerin
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.
11-Digit NDC Billing Format:
69396012703
Product Type:
Human Otc Drug
Labeler Name:
Trifecta Pharmaceuticals Usa Llc
Dosage Form:
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route(s):
  • 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):
  • GLYCERIN 20 g/100g
    • Pharmacologic Class(es):
  • Allergens - [CS]
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Glycerol - [CS]
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Increased IgG Production - [PE] (Physiologic Effect)
  • Non-Standardized Chemical Allergen - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    M016
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    08-14-2023
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 69396-127-03?

    The NDC Packaged Code 69396-127-03 is assigned to a package of 1 tube in 1 box / 84.7 g in 1 tube of Hydro Gel, a human over the counter drug labeled by Trifecta Pharmaceuticals Usa Llc. The product's dosage form is gel and is administered via topical form.

    Is NDC 69396-127 included in the NDC Directory?

    Yes, Hydro Gel with product code 69396-127 is active and included in the NDC Directory. The product was first marketed by Trifecta Pharmaceuticals Usa Llc on August 14, 2023 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 69396-127-03?

    The 11-digit format is 69396012703. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-269396-127-035-4-269396-0127-03