NDC 55882-3499 Hello Naturally Fresh Antiseptic

Menthol, Unspecified Form

NDC Product Code 55882-3499

NDC CODE: 55882-3499

Proprietary Name: Hello Naturally Fresh Antiseptic 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, Unspecified Form 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.

Product Characteristics

MINT (C73404)

NDC Code Structure

  • 55882 - Hello Products Llc
    • 55882-3499 - Hello Naturally Fresh Antiseptic

NDC 55882-3499-3

Package Description: 473 mL in 1 BOTTLE

NDC Product Information

Hello Naturally Fresh Antiseptic with NDC 55882-3499 is a a human over the counter drug product labeled by Hello Products Llc. The generic name of Hello Naturally Fresh Antiseptic is menthol, unspecified form. The product's dosage form is mouthwash and is administered via dental form.

Labeler Name: Hello Products Llc

Dosage Form: Mouthwash - An aqueous solution which is most often used for its deodorant, refreshing, or antiseptic effect.

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.

Hello Naturally Fresh Antiseptic 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.

  • Dental - Administration to a tooth or teeth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Hello Products Llc
Labeler Code: 55882
FDA Application Number: part356 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: 03-21-2021 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.

Hello Naturally Fresh Antiseptic Product Label Images

Hello Naturally Fresh Antiseptic 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


Drug Facts

Dist. by Hello Products LLCMontclair, NJ 07042

Active Ingredient

Menthol 0.2%




First aid to help protect against oral infection.

Otc - Ask Doctor

Ask a dentist if symptoms persist or condition worsens after regular use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


  • Adults and children 12 years of age and older: Rinse for 30 seconds with 20mL (about 1 capful) twice a day. Do not swallow.children 6 years to under 12 years of age: supervise use.children under 6 years of age: do not use

Inactive Ingredients

Purified water, vegetable glycerin, polysorbate 80, flavor, xylitol, erythritol, poloxamer 407, sodium benzoate and tea tree oil.

Other Information

This rinse is not intended to replace brushing or flossing.



* Please review the disclaimer below.