NDC 59779-853 Hydrating Healing Skin Protectant

Petrolatum Ointment Ointment Topical - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
59779-853
Proprietary Name:
Hydrating Healing Skin Protectant
Non-Proprietary Name: [1]
Petrolatum Ointment
Substance Name: [2]
Petrolatum
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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.
Administration Route(s): [4]
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Labeler Name: [5]
    Cvs Pharmacy
    Labeler Code:
    59779
    FDA Application Number: [6]
    M016
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    07-25-2016
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325)

    Product Packages

    NDC Code 59779-853-02

    Package Description: 2 TUBE in 1 CARTON / 9.9 g in 1 TUBE (59779-853-01)

    NDC Code 59779-853-03

    Package Description: 85 g in 1 TUBE

    Product Details

    What is NDC 59779-853?

    The NDC code 59779-853 is assigned by the FDA to the product Hydrating Healing Skin Protectant which is a human over the counter drug product labeled by Cvs Pharmacy. The generic name of Hydrating Healing Skin Protectant is petrolatum ointment. The product's dosage form is ointment and is administered via topical form. The product is distributed in 2 packages with assigned NDC codes 59779-853-02 2 tube in 1 carton / 9.9 g in 1 tube (59779-853-01), 59779-853-03 85 g in 1 tube . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Hydrating Healing Skin Protectant?

    Apply as neededfor diaper rash, change wet and soiled diapers promptly, cleanse the diaper area and allow to dry.  Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

    What are Hydrating Healing Skin Protectant Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • PETROLATUM 41 g/100g - A colloidal system of semisolid hydrocarbons obtained from PETROLEUM. It is used as an ointment base, topical protectant, and lubricant.

    Which are Hydrating Healing Skin Protectant UNII Codes?

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

    Which are Hydrating Healing Skin Protectant Inactive Ingredients 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 Hydrating Healing Skin Protectant?

    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:

    * Please review the disclaimer below.

    Product Footnotes

    [1] 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.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

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

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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.

    [12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".