NDC 0363-1973 Hydrocortisone
Cream Topical

Product Information

What is NDC 0363-1973?

The NDC code 0363-1973 is assigned by the FDA to the product Hydrocortisone which is a human over the counter drug product labeled by Walgreen Company. The product's dosage form is cream and is administered via topical form. The product is distributed in 3 packages with assigned NDC codes 0363-1973-16 1 tube in 1 carton / 56 g in 1 tube, 0363-1973-26 2 tube in 1 carton / 56 g in 1 tube, 0363-1973-64 1 tube in 1 carton / 28 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, RxNorm crosswalk and the complete product label.

NDC Product Code0363-1973
Proprietary Name 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.		Hydrocortisone
Non-Proprietary Name 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.		Hydrocortisone
Product Type 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.		Human Otc Drug
Dosage FormCream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 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) 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.		Walgreen Company
Labeler Code0363
FDA Application Number 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.		part348
Marketing Category 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.		OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		01-09-2018
Listing Expiration Date 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.		12-31-2023
Exclude Flag 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". 		N
NDC Code Structure

What are the uses for Hydrocortisone?


Product Characteristics

Color(s)WHITE (C48325)

Product Packages

NDC Code 0363-1973-16

Package Description: 1 TUBE in 1 CARTON / 56 g in 1 TUBE

NDC Code 0363-1973-26

Package Description: 2 TUBE in 1 CARTON / 56 g in 1 TUBE

NDC Code 0363-1973-64

Package Description: 1 TUBE in 1 CARTON / 28 g in 1 TUBE

Product Details

What are Hydrocortisone 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.
  • HYDROCORTISONE 1 g/100g - The main glucocorticoid secreted by the ADRENAL CORTEX. Its synthetic counterpart is used, either as an injection or topically, in the treatment of inflammation, allergy, collagen diseases, asthma, adrenocortical deficiency, shock, and some neoplastic conditions.

Hydrocortisone Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? 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:

Hydrocortisone 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.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Patient Education

Hydrocortisone Topical

Hydrocortisone Topical is pronounced as (hye droe kor' ti sone)

Why is hydrocortisone topical medication prescribed?
Hydrocortisone topical is used to treat redness, swelling, itching, and discomfort of various skin conditions. Hydrocortisone is in a class of medications called corticos...
[Read More]

* Please review the disclaimer below.

Hydrocortisone Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Active Ingredient



Hydrocortisone 1%


Purpose



Anti-itch


Uses



  • •temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
  • •eczema
  • •psoriasis
  • •poison ivy, oak, sumac
  • •insect bites
  • •detergents
  • •jewelry
  • •cosmetics
  • •soaps
  • •seborrheic dermatitis
  • •temporarily relieves external anal and genital itching
  • •other uses of this product should be only under the advice and supervision of a doctor

Warnings



For external use only


Do Not Use



  • •in the genital area if you have a vaginal discharge. Ask a doctor.
  • •for the treatment of diaper rash. Ask a doctor.

When Using This Product



  • •avoid contact with the eyes
  • •do not use more than directed unless told to do so by a doctor
  • •do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop Use And Ask A Doctor If



  • •condition worsens
  • •rectal bleeding occurs
  • •symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor

Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • •for itching of skin irritation, inflammation, and rashes:
  • •adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • •children under 2 years of age: do not use, ask a doctor
  • •for external anal and genital itching, adults:
  • •when practical, clean the affected area with mild soap and warm water and rinse thoroughly
  • •gently dry by patting or blotting with toilet tissue or a soft cloth before applying
  • •apply to affected area not more than 3 to 4 times daily
  • •children under 12 years of age: ask a doctor

Other Information



  • •store at 20°-25°C (68°-77°F)

Inactive Ingredients



aloe barbadensis leaf juice, aluminum sulfate, calcium acetate, cetearyl alcohol, cetyl alcohol, cholecalciferol, dextrin, glycerin, isopropyl palmitate, light mineral oil, maltodextrin, methylparaben, propylene glycol, propylparaben, purified water, retinyl palmitate, sodium cetearyl sulfate, sodium lauryl sulfate, tocopherol, white petrolatum, white wax, zea mays (corn) oil


Questions Or Comments?



1-800-719-9260


Principal Display Panel



Fights itch fast with moisturizing relief for:

Skin irritations, rashes, redness, inflammation, eczema & psoriasis

Compare to Cortizone 10® Plus active ingredient

+ VITAMINS A, D & E + ALOE MAXIMUM STRENGTH

Ultra-Moisturizing

Hydrocortisone Cream

10 MOISTURIZERS ENRICHED WITH VITAMINS & ALOE / HYDROCORTISONE 1%

ANTI-ITCH CREAM

NET WT 2 OZ (56 g)


* Please review the disclaimer below.