NDC 61577-4020 Sombra Warm Therapy
Menthol Camphor Gel Topical

Product Information

NDC Product Code61577-4020
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.		Sombra Warm Therapy
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.		Menthol Camphor
Substance Name 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.		Camphor (synthetic); Menthol
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
NDC Directory StatusACTIVE PRODUCT and included in NDC Directory
Dosage FormGel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
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.		Sombra Cosmetics Inc.
Labeler Code61577
SPL SET ID:b0d64c55-3d11-4659-9195-136b05ffe3d7
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.		03-10-2023
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.		12-31-2024
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

Product Packages

NDC Code 61577-4020-1

Package Description: 3628.7 g in 1 BOTTLE, PUMP

NDC Code 61577-4020-2

Package Description: 907.2 g in 1 BOTTLE, PUMP

NDC Code 61577-4020-3

Package Description: 226.8 g in 1 JAR

NDC Code 61577-4020-4

Package Description: 113.4 g in 1 JAR

NDC Code 61577-4020-5

Package Description: 85 g in 1 BOTTLE, PLASTIC

Product Details

What is NDC 61577-4020?

The NDC code 61577-4020 is assigned by the FDA to the product Sombra Warm Therapy which is a human over the counter drug product labeled by Sombra Cosmetics Inc.. The generic name of Sombra Warm Therapy is menthol camphor. The product's dosage form is gel and is administered via topical form. The product is distributed in 5 packages with assigned NDC codes 61577-4020-1 3628.7 g in 1 bottle, pump , 61577-4020-2 907.2 g in 1 bottle, pump , 61577-4020-3 226.8 g in 1 jar , 61577-4020-4 113.4 g in 1 jar , 61577-4020-5 85 g in 1 bottle, plastic . 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 Sombra Warm Therapy?

This product is used as Purpose External Analgesic . Temporarily relieves minor aches and pains of muscles and joints associated with: arthritis, simple backaches

What are Sombra Warm Therapy 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.

Which are Sombra Warm Therapy UNII Codes?

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

What is the NDC to RxNorm Crosswalk for Sombra Warm Therapy?

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: 1090954 - SOMBRA Warm Therapy 3 % / 3 % Topical Gel
  • RxCUI: 1090954 - camphor 0.03 MG/MG / menthol 0.03 MG/MG Topical Gel [SOMBRA Warm Pain Relieving Gel]
  • RxCUI: 1090954 - SOMBRA Warm Pain Relieving Gel (camphor 3 % / menthol 3 % ) Topical Gel
  • RxCUI: 630714 - camphor 3 % / menthol 3 % Topical Gel
  • RxCUI: 630714 - camphor 0.03 MG/MG / menthol 0.03 MG/MG Topical Gel

Which are Sombra Warm Therapy 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:

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Product Label

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