NDC 72827-101 Matys Organic Baby Diaper Rash Relief


NDC Product Code 72827-101

NDC Code: 72827-101

Proprietary Name: Matys Organic Baby Diaper Rash Relief What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Calendula 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.

NDC Code Structure

  • 72827 - Matys Healthy Products Llc
    • 72827-101 - Matys Organic Baby Diaper Rash Relief

NDC 72827-101-10

Package Description: 284 g in 1 JAR

NDC Product Information

Matys Organic Baby Diaper Rash Relief with NDC 72827-101 is a a human over the counter drug product labeled by Matys Healthy Products Llc. The generic name of Matys Organic Baby Diaper Rash Relief is calendula. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Matys Healthy Products Llc

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug 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.

Matys Organic Baby Diaper Rash Relief Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • ALOE (UNII: V5VD430YW9)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Matys Healthy Products Llc
Labeler Code: 72827
Marketing Category: UNAPPROVED HOMEOPATHIC - 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.

Start Marketing Date: 02-18-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Matys Organic Baby Diaper Rash Relief Product Label Images

Matys Organic Baby Diaper Rash Relief Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Calendula 3X HPUS


Skin Protectant


- Helps treat and prevent diaper rash.- Protects chafed skin due to diaper rash and helps seal out wetness.


- For external use only.- When using this product | Do not get into eyes.- Stop use and ask a doctor if | Condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

Otc - Keep Out Of Reach Of Children

- Keep out of reach of children| If swallowed, get medical help or contact Poison Control Center.


Apply as often as needed to your baby's bottom or dry skin. Clean and dry area before use to create a moisture barrier that protects your baby's skin.

Other Information

- Store at room temperature.

Other Ingredients

Olive Oil*, Coconut Oil*, Castor Oil*, Beeswax*, Aloe Extract*, Jojoba Oil*, Zinc oxide, Frankincense Essential Oil*, Lavender Essential Oil**Organic

* Please review the disclaimer below.

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