Hydrocortisone Acetate, Iodoquinol Cream
NDC 52187-551
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Hydrocortisone Acetate, Iodoquinol is a UNAPPROVED DRUG OTHER-approved product labeled by Kmm Pharmaceuticals, Llc. This medication is typically used as a corticosteroid hormone receptor agonists [moa]. It is supplied as a green cream for topical administration. This product entry covers the primary NDC 52187-551 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
52187-551
Proprietary Name:
Hydrocortisone Acetate, Iodoquinol
Non-Proprietary Name: [1]
Hydrocortisone Acetate, Iodoquinol
Substance Name: [2]
Hydrocortisone Acetate; Iodoquinol
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Cream
- 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): [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 & Regulatory Data
Labeler Name: [5]
Labeler Code:
52187
Product Label ID:
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]
02-28-2022
End Marketing Date: [10]
08-31-2027
Exclude Flag: [12]
N
Product Characteristics
Color(s):
GREEN (C48329)
Code Structure Chart
Product Details
What is NDC 52187-551?
The NDC code 52187-551 is assigned by the FDA to the product Hydrocortisone Acetate, Iodoquinol. This pharmaceutical product is labeled by Kmm Pharmaceuticals, Llc and is currently categorized as listed product. The medication is a cream administered via topical route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 52187-551-30. 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?
Based on a review of a related drug by the National Research Council and subsequent FDA classification for that drug, the indications are as follows: “Possibly” Effective: Contact or atopic dermatitis; impetiginized eczema; nummular eczema; endogenous chronic infectious dermatitis; stasis dermatitis; pyoderma; nuchal eczema and chronic eczematoid otitis externa; acne urticata; localized or disseminated neurodermatitis; lichen simplex chronicus; anogenital pruritus (vulvae, scroti, ani); folliculitis; bacterial dermatoses; mycotic dermatoses such as tinea (capitis, cruris, corporis, pedis); monliasis; intertrigo. Final classification of the less-than-effective indications requires further investigation.
What are Active Ingredients of this product?
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 ACETATE 19 mg/g - RN given refers to cpd without isomeric designation
- IODOQUINOL 10 mg/g - One of the halogenated 8-quinolinols widely used as an intestinal antiseptic, especially as an antiamebic agent. It is also used topically in other infections and may cause CNS and eye damage. It is known by very many similar trade names world-wide.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- HYDROCORTISONE ACETATE (UNII: 3X7931PO74)
- HYDROCORTISONE (UNII: WI4X0X7BPJ) (Active Moiety)
- IODOQUINOL (UNII: 63W7IE88K8)
- IODOQUINOL (UNII: 63W7IE88K8) (Active Moiety)
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:
- ALOE VERA LEAF (UNII: ZY81Z83H0X)
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:
- RxCUI: 1436947 - hydrocortisone acetate 1.9 % / iodoquinol 1 % Topical Cream
- RxCUI: 1436947 - hydrocortisone acetate 19 MG/ML / iodoquinol 10 MG/ML Topical Cream
Which are the Pharmacologic Classes of this product?
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 full disclaimer at the bottom of this page.
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 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.
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 are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
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 End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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".
