Little Remedies New Baby Essentials Kit
NDC 63029-615

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 63029-615?
  5. Little Remedies New Baby Essentials Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

Little Remedies New Baby Essentials (acetaminophen, simethicone, zinc oxide) is a UNAPPROVED DRUG OTHER-approved product labeled by Medtech Products Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a white kit. This product entry covers the primary NDC 63029-615 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
63029-615
Proprietary Name:
Little Remedies New Baby Essentials
Non-Proprietary Name: [1]
Acetaminophen, Simethicone, Zinc Oxide
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Kit - A packaged collection of related material.

Labeler & Regulatory Data

Labeler Name: [5]
Medtech Products Inc.
Labeler Code:
63029
Product Label ID:
4b1b7294-aca6-45fa-a008-c1869131b2a3
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.

Marketing Timeline

Start Marketing Date: [9]
02-15-2017
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
WHITE (C48325)
WHITE (C48325 - BEIGE)
WHITE (C48325 - CLEAR)
Flavor(s):

Code Structure Chart

Product Details

What is NDC 63029-615?

The NDC code 63029-615 is assigned by the FDA to the product Little Remedies New Baby Essentials. It is commonly known by its generic name, acetaminophen, simethicone, zinc oxide. This pharmaceutical product is labeled by Medtech Products Inc. and is currently categorized as listed product. The medication is a kit. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 63029-615-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".