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

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

Package Information

Little Remedies New Baby Essentials (acetaminophen, simethicone, zinc oxide) kits is 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. This formulation utilizes a kit delivery system. Marketed by Medtech Products Inc., this product is identified by NDC 63029-615.

Identification & Billing

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
63029-615
11-Digit Billing Format
63029061501
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Little Remedies New Baby Essentials
Non-Proprietary Name
Acetaminophen, Simethicone, Zinc Oxide
Dosage Form
Kit - A packaged collection of related material.
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.

Regulatory & Marketing

Labeler Name
Medtech Products Inc.
Product Type
Human Otc Drug
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
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 63029-615-01 identifies a specific commercial 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.. This kit is formulated for use and contains 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 Medtech Products Inc. on February 15, 2017. The current certification is valid through December 31, 2026.

How is this Medtech Products Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63029061501. 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 (5-3-2)
63029-615-01
11-Digit CMS (5-4-2)
63029-0615-01

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