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  5. NDC Package Code: 21130-981-02 Signature Care Hemorrhoidal Cream (with Applicator)

NDC Package 21130-981-02 Signature Care Hemorrhoidal Cream (with Applicator)

Phenylephrine Hydrochloride,Pramoxine Hydrochloride,Glycerin,Petrolatum Cream 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:
21130-981-02
Package Description:
1 TUBE, WITH APPLICATOR in 1 CARTON / 57 g in 1 TUBE, WITH APPLICATOR
Product Code:
21130-981
Proprietary Name:
Signature Care Hemorrhoidal Cream (with Applicator)
Non-Proprietary Name:
Phenylephrine Hydrochloride, Pramoxine Hydrochloride, Glycerin, Petrolatum
Substance Name:
Glycerin; Petrolatum; Phenylephrine Hydrochloride; Pramoxine Hydrochloride
Usage Information:
Directionsadults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying cream.when first opening the tube, peel back foil sealapply externally or in the lower portion of the anal canal onlyapply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movementfor application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing cap well, then gently insert dispensing cap partway into the anusthoroughly cleanse dispensing cap after each use and replace coverchildren under 12 years of age: ask a doctor
11-Digit NDC Billing Format:
21130098102
NDC to RxNorm Crosswalk:
  • RxCUI: 1293649 - glycerin 14.4 % / phenylephrine HCl 0.25 % / pramoxine HCl 1 % / white petrolatum 15 % Rectal Cream
  • RxCUI: 1293649 - glycerin 144 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream
  • RxCUI: 1293649 - glycerin 14.4 % / phenylephrine hydrochloride 0.25 % / pramoxine hydrochloride 1 % / white petrolatum 15 % Rectal Cream
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Better Living Brands, Llc
    Dosage Form:
    Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
    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 144 mg/g
  • PETROLATUM 150 mg/g
  • PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/g
  • PRAMOXINE HYDROCHLORIDE 10 mg/g
    • Pharmacologic Class(es):
  • Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
  • 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)
  • alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    part346
    Marketing Category:
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date:
    01-04-2021
    Listing Expiration Date:
    12-31-2024
    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 21130-981-02?

    The NDC Packaged Code 21130-981-02 is assigned to a package of 1 tube, with applicator in 1 carton / 57 g in 1 tube, with applicator of Signature Care Hemorrhoidal Cream (with Applicator), a human over the counter drug labeled by Better Living Brands, Llc. The product's dosage form is cream and is administered via topical form.

    Is NDC 21130-981 included in the NDC Directory?

    Yes, Signature Care Hemorrhoidal Cream (with Applicator) with product code 21130-981 is active and included in the NDC Directory. The product was first marketed by Better Living Brands, Llc on January 04, 2021 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 21130-981-02?

    The 11-digit format is 21130098102. 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
    5-3-221130-981-025-4-221130-0981-02