NDC 73603-141 Comforte Natural Menstrual Cramp Relief Cream

Menthol, Methyl Salicylate

NDC Product Code 73603-141

NDC CODE: 73603-141

Proprietary Name: Comforte Natural Menstrual Cramp Relief Cream 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.

Non-Proprietary Name: Menthol, Methyl Salicylate 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.

NDC Code Structure

  • 73603 - Pms4pms, Llc
    • 73603-141 - Comforte Natural Menstrual Cramp Relief Cream

NDC 73603-141-96

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

NDC Product Information

Comforte Natural Menstrual Cramp Relief Cream with NDC 73603-141 is a a human over the counter drug product labeled by Pms4pms, Llc. The generic name of Comforte Natural Menstrual Cramp Relief Cream is menthol, methyl salicylate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Pms4pms, Llc

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.

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.

Comforte Natural Menstrual Cramp Relief Cream 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.

  • MENTHOL 1.4 g/100g

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.


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.
  • 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: Pms4pms, Llc
Labeler Code: 73603
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: 05-06-2020 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: 12-31-2021 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Comforte Natural Menstrual Cramp Relief Cream Product Label Images

Comforte Natural Menstrual Cramp Relief Cream 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 Purpose

Active Ingredient PurposeMenthol 1.4%......................... Topical AnalgesicMethyl Salicylate 10% ….….. Topical Analgesic


PurposeTopical Analgesic


Uses Temporarily relieves minor pain associated with cramps


WarningsFor external use onlyAllergy alert: if prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Otc - Stop Use

Stop use and ask a doctor if * condition worsens or symptoms persist for more than 7 days * symptoms clear up and occur again within a few days * excessive skin irritation occurs

Otc - When Using

When using this product * use only as directed * do not bandage tightly or use with a heating pad * avoid contact with eyes or mucuous membranes * do not apply to wounds or damaged skin

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away


Directionsadults and children over 12 years: * apply generously to affected area * massage into painful area until thoroughly absorbed into skin * repeat as necessary, but no more than 4 times daily *
children 12 years or younger; ask a doctor

Inactive Ingredient

Inactive ingredients Calotropis Procera Extract, Carapa Procera Oil, Sandalwood Oil, Shea Butter, Soybean Oil

Otc - Questions

Questions? Call 877.590.6257

* Please review the disclaimer below.