NDC 73359-002 Roots Professional - Topical Solution Hair Regrowth Treatment

Minoxidil 5%

NDC Product Code 73359-002

NDC CODE: 73359-002

Proprietary Name: Roots Professional - Topical Solution Hair Regrowth Treatment 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: Minoxidil 5% 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Minoxidil is used with other medications to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Minoxidil works by relaxing blood vessels so blood can flow more easily.

NDC Code Structure

  • 73359 - Roots Hair Club, Llc
    • 73359-002 - Roots Professional - Topical Solution Hair Regrowth Treatment

NDC 73359-002-01

Package Description: 1 BOTTLE in 1 BOX > 60 mL in 1 BOTTLE

NDC Product Information

Roots Professional - Topical Solution Hair Regrowth Treatment with NDC 73359-002 is a a human over the counter drug product labeled by Roots Hair Club, Llc. The generic name of Roots Professional - Topical Solution Hair Regrowth Treatment is minoxidil 5%. The product's dosage form is solution and is administered via topical form.

Labeler Name: Roots Hair Club, Llc

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Roots Professional - Topical Solution Hair Regrowth Treatment 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.

  • MINOXIDIL 5 g/100mL

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.
  • 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: Roots Hair Club, Llc
Labeler Code: 73359
FDA Application Number: ANDA076239 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: ANDA - A product marketed under an approved Abbreviated New Drug Application. 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: 09-11-2019 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: 12-31-2020 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.

Roots Professional - Topical Solution Hair Regrowth Treatment Product Label Images

Roots Professional - Topical Solution Hair Regrowth Treatment 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

Otc - Active Ingredient

Minoxidil 5% w/v

Otc - Purpose

Hair regrowth treatment for men


Use to regrow hair on the top of the scalp (vertex only, see pictures on side of carton).


For external use only. For use by men only.Flammable: Keep away from fire or flame

Otc - Do Not Use

  • Do not use if:You are a womanYour amount of hair loss is different than shown on the side of this carton or hair loss is on the front of the scalp, 5% minoxidil topical solution is not intended for frontal baldness or receding hairlineYou have no family history of hair lossYour hair loss is sudden and/or patchyYou do not know the reason for your hair lossYou are under 18 years of age. Do not use on babies or childrenYour scalp is red, inflamed, infected, irritated, or painfulYou use other medicines on the scalp

Otc - Ask Doctor

Ask your doctor before use if you have heart disease.

Otc - When Using

  • When using this productDo not apply on other parts of the bodyAvoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap waterSome people have expereinced changes in hair color and/or textureIt takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see resultsThe amount of hair regrowth is different for each personThis product will not work for all men

Otc - Stop Use

  • Stop use and ask a doctor ifChest pain, rapid heart beat, faintness, or dissiness occursSudden, unexplained weight gain occursYour hands of feet swellScalp irritation or redness occursYou get unwanted facial hair growthYou do not see hair regrowth in 4 months


  • Apply 1mL with sprayer (6 sprays) 2 times a day directly onto the scalp in the hair loss areausing more or more often will not improve resultscontinued use is necessary to increase and keep your hair regrowth, or hair loss will begin again

Other Safety Information

  • See hair loss pictures on the side of this cartonBefore use, read all information on carton and enclosed leafletKeep the carton. It contains important informationHair regrowth has not been shown to last longer than 48 weeks in large clinical trialse with continuous treatment with 5% minoxidil topical solution for menIn clincial studies of mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provide more hair regrowth than 2% minoxidil topical solutionStore at controlled room temperature 20
  • O to 25
  • O C (68
  • O to 77
  • O F)

Inactive Ingredient

Alcohol, Propylene Glycol, Purified Water

Otc - Keep Out Of Reach Of Children

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

Otc - Pregnancy Or Breast Feeding

May be harmful if used when pregnant or breast-feeding.

* Please review the disclaimer below.