NDC 71399-0120 Hydrocortisone


NDC Product Code 71399-0120

NDC 71399-0120-1

Package Description: 1 BOTTLE in 1 CARTON > 120 mL in 1 BOTTLE

NDC Product Information

Hydrocortisone with NDC 71399-0120 is a a human over the counter drug product labeled by Akron Pharma Inc. The generic name of Hydrocortisone is hydrocortisone. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Akron Pharma Inc

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Hydrocortisone 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.

  • WATER (UNII: 059QF0KO0R)

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: Akron Pharma Inc
Labeler Code: 71399
FDA Application Number: part348 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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 05-17-2021 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: 12-31-2022 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 - NO 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".

* Please review the disclaimer below.

Hydrocortisone Product Label Images

Hydrocortisone 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

Hydrocortisone 1% (Micronized)


Antipruritic (Anti-itch)


  • For the temporary relief of minor skin irritations, inflammations, itching and rashes caused by:insect biteseczemapsoriasissoapsdetergentscosmetics,jewelry,poison oak,poison sumacOther uses of this product should be undertaken only under the advice and supervision of a doctor.


For external use only.

When Using This Product

Do not get into eyes. If contact occurs, rinse thoroughly with water.

Stop Use And Ask A Doctor If

  • Condition worsensIf symptoms persist for more than 7 days or clear up and occur again within a few days. Discontinue use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor.Do no use for diaper rash. Consult a doctor.

Keep Out Of Reach Of Children

Keep out of the reach of children. If swallowed, get medical help or contact Poison Control Center right away.


  • Shake will before using.For adults and children 2 years of age and older: Apply to affected area not more than 2 to 4 times daily.For children under 2 years of age: there is no recommended dosage except under the advice and supervision of a doctor.

Other Information

• Store away from excessive heat or cold. Shake well before using.

Inactive Ingredients

Purified Water, Glycerin, Cetyl Alcohol, Benzyl Alcohol, Sodium Lauryl Sulfate, Stearyl Alcohol, Aloevera, Xanthan Gum


Please Call 1(877) 225-6999


Manufactured for:Akron Pharma, Inc.Fairfield, NJ 07004Rev. 03/19Manufactured in U.S.A

* Please review the disclaimer below.