NDC 81301-0512 Up Toothpaste, Lemon Citron

Sodium Fluoride Toothpaste

NDC Product Code 81301-0512

NDC CODE: 81301-0512

Proprietary Name: Up Toothpaste, Lemon Citron 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: Sodium Fluoride Toothpaste 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

Flavor(s):
CITRUS (C73378)

NDC Code Structure

  • 81301 - Tao Clean, Llc

NDC 81301-0512-2

Package Description: 1 TUBE in 1 BOX > 68.57 g in 1 TUBE (81301-0512-1)

NDC Product Information

Up Toothpaste, Lemon Citron with NDC 81301-0512 is a a human over the counter drug product labeled by Tao Clean, Llc. The generic name of Up Toothpaste, Lemon Citron is sodium fluoride toothpaste. The product's dosage form is paste, dentifrice and is administered via dental form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 416783.

Dosage Form: Paste, Dentifrice - A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.

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.

Up Toothpaste, Lemon Citron 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.

  • STEVIA LEAF (UNII: 6TC6NN0876)
  • SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
  • PYRIDOXINE (UNII: KV2JZ1BI6Z)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • THEANINE (UNII: 8021PR16QO)
  • WATER (UNII: 059QF0KO0R)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • XYLITOL (UNII: VCQ006KQ1E)
  • SORBITOL (UNII: 506T60A25R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CAFFEINE (UNII: 3G6A5W338E)
  • METHYLCOBALAMIN (UNII: BR1SN1JS2W)

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: Tao Clean, Llc
Labeler Code: 81301
FDA Application Number: part355 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 08-16-2021 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.

Up Toothpaste, Lemon Citron 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 Ingredients

Sodium fluoride 0.24%

Purpose

Anticavity

Uses

Aids in the prevention of dental cavities.

Warnings

If more than used for brushing is accidentally swallowed, get medical help orcontact a Poison Control Center right away.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children under 6 years of age.

Directions

1 Wet toothbrush and apply a generous amount of your Whole Body Toothpaste2 Brush thoroughly for 2 minutes.3 Rinse and spit out paste after brushing.4 Do not swallow.

Inactive Ingredients

Inactive ingredients (up): Sorbitol, glycerin, xylitol, water, hydrated silica, chamomile, sodium carboxymethylcellulose, sodium methyl cocoyl taurate, sodium bicarbonate, lemon balm, titanium dioxide, stevia, sodium fluoride, benzoic acid, melatonin, L-Theanine
Inactive ingredients (down): sorbitol, glycerin, xylitol, hydrated silica, water, anthemis nobilis (chamomile), sodium bicarbonate, sodium carboxymethylcellulose, sodium methyl cocoyl taurate, lemon balm extract, titanium dioxide, stevia, benzoic acid, melatonin, l-theanine, nutmeg, ginger root, cinnamomum zeylanicum (cinnamon) oil

Attention

Twist off cap to remove foil sealDo not use if the safety seal is missing or brokenThis product contains caffeine, which could be something to avoid if you are sensitiveFor human use only

Need Help With Anything?

We want to help!Talk to a human: +1 714 363 3599Write to us: [email protected] Distributed by TAO Clean® LLC. Orange, CA 92866 Proudly made in the USA UP TOOTHPASTE, LEMON CITRON, 60 ML 81301-0512-01 • DOWN TOOTHPASTE, GINGERSNAP, 60 ML 81301-0513-0120352 • BA-0511-IM

* Please review the disclaimer below.