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  5. NDC Package Code: 64616-115-01 Comfort For Teething

NDC Package 64616-115-01 Comfort For Teething

Liquid Oral - 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:
64616-115-01
Package Description:
30 mL in 1 BOTTLE, DROPPER
Product Code:
64616-115
Proprietary Name:
Comfort For Teething
Non-Proprietary Name:
Comfort For Teething
Substance Name:
Arnica Montana; Chamomile; Magnesium Phosphate, Monobasic, Unspecified; Rheum Officinale Root; Tribasic Calcium Phosphate; Wood Creosote
Usage Information:
Do not use if printed neck seal is broken or missing use only as directed. For infants 4 months and older: give 4 drops under the tongue every 30 minutes for 4 doses. Then reduce to once every 4 hours or as recommended by a doctor.
11-Digit NDC Billing Format:
64616011501
Product Type:
Human Otc Drug
Labeler Name:
Vitality Works, Inc.
Dosage Form:
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ARNICA MONTANA 6 [hp_X]/.05mL
  • CHAMOMILE 3 [hp_X]/.05mL
  • MAGNESIUM PHOSPHATE, MONOBASIC, UNSPECIFIED 6 [hp_X]/.05mL
  • RHEUM OFFICINALE ROOT 6 [hp_X]/.05mL
  • TRIBASIC CALCIUM PHOSPHATE 6 [hp_X]/.05mL
  • WOOD CREOSOTE 6 [hp_X]/.05mL
    • Pharmacologic Class(es):
  • Blood Coagulation Factor - [EPC] (Established Pharmacologic Class)
  • Calcium - [CS]
  • Cations, Divalent - [CS]
  • Increased Coagulation Factor Activity - [PE] (Physiologic Effect)
  • Phosphate Binder - [EPC] (Established Pharmacologic Class)
  • Phosphate Chelating Activity - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    Marketing Category:
    UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
    Start Marketing Date:
    07-05-2013
    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 64616-115-01?

    The NDC Packaged Code 64616-115-01 is assigned to a package of 30 ml in 1 bottle, dropper of Comfort For Teething, a human over the counter drug labeled by Vitality Works, Inc.. The product's dosage form is liquid and is administered via oral form.

    Is NDC 64616-115 included in the NDC Directory?

    Yes, Comfort For Teething with product code 64616-115 is active and included in the NDC Directory. The product was first marketed by Vitality Works, Inc. on July 05, 2013 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 64616-115-01?

    The 11-digit format is 64616011501. 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
    5-3-264616-115-015-4-264616-0115-01