NDC Package 63029-615-01 Little Remedies New Baby Essentials

Acetaminophen,Simethicone,Zinc Oxide Kit - View Billable Units, 11-Digit Format, RxNorm

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:
63029-615-01
Package Description:
1 KIT in 1 CARTON * 57 g in 1 TUBE * 59 mL in 1 BOTTLE * 15 mL in 1 BOTTLE * 30 mL in 1 BOTTLE * 59 mL in 1 BOTTLE
Product Code:
Proprietary Name:
Little Remedies New Baby Essentials
Non-Proprietary Name:
Acetaminophen, Simethicone, Zinc Oxide
Usage Information:
This product does not contain directions or complete warnings for adult use.Shake well before usingFind the right dose on the chart on the chart below. If possible, use weight to determine dose; otherwise, use age.Only use the enclosed AccuSafe® syringe. Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child.  Remove cap, insert syringe to flow restrictor and invert bottlePull back syringe until filled to the prescribed level and slowly dispense the liquid into your child’s mouth (towards the inner cheek)If needed, repeat dose every 4 hours while symptoms lastDo not give more than 5 times in any 24-hour period (see overdose warning)Do not give more than 5 days unless directed by a doctorReplace cap tightly to maintain child resistancemL = milliliterWeight (lbs)Age (yrs)Dose (mL)Under 24under 2Ask a doctor24-352-35 mL ■ shake well before using■ only use enclosed syringe; fill to prescribed level and dispense liquid slowly into child’s mouth, toward inner cheek■ all dosages may be repeated as needed, after meals and at bedtime or as directed by a physician. Do not exceed 12 doses per day.■ dosage can also be mixed with 1 oz. of cool water, infant formula or other suitable liquids■ for best results, clean syringe after each use and replace original capIf possible, use weight to determine dose; otherwise use age.mL = millilitersAge (yrs)Weight (lbs)DoseNewborns &Infants under 2 yearsunder 240.3 mLChildren 2 years and over24 and over0.6 mL (For nasal use only)▪ Infants: 2 to 6 drops in each nostril as often as needed or as directed by your doctor. ▪Children: 2 to 6 sprays or drops into each nostril as often as needed or as directed by a doctor.Store at 20°-25°C (68°-77°F). See bottle for lot and expiration date.
11-Digit NDC Billing Format:
63029061501
NDC to RxNorm Crosswalk:
  • RxCUI: 198857 - simethicone 20 MG in 0.3 mL Oral Suspension
  • RxCUI: 198857 - simethicone 66.7 MG/ML Oral Suspension
  • RxCUI: 198857 - simethicone 20 MG per 0.3 ML Oral Suspension
  • RxCUI: 198857 - simethicone 40 MG per 0.6 ML Oral Suspension
  • RxCUI: 307675 - acetaminophen 160 MG in 5 mL Oral Solution
  • Product Type:
    Human Otc Drug
    Labeler Name:
    Medtech Products Inc.
    Dosage Form:
    Kit - A packaged collection of related material.
    Sample Package:
    No
    Marketing Category:
    UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
    Start Marketing Date:
    02-15-2017
    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 63029-615-01?

    The NDC Packaged Code 63029-615-01 is assigned to a package of 1 kit in 1 carton * 57 g in 1 tube * 59 ml in 1 bottle * 15 ml in 1 bottle * 30 ml in 1 bottle * 59 ml in 1 bottle of Little Remedies New Baby Essentials, a human over the counter drug labeled by Medtech Products Inc.. The product's dosage form is kit and is administered via form.

    Is NDC 63029-615 included in the NDC Directory?

    Yes, Little Remedies New Baby Essentials with product code 63029-615 is active and included in the NDC Directory. The product was first marketed by Medtech Products Inc. on February 15, 2017 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 63029-615-01?

    The 11-digit format is 63029061501. 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
    5-3-263029-615-015-4-263029-0615-01