NDC 10237-675 Complete Care Whole Mouth Protection

Sodium Fluoride

NDC Product Code 10237-675

NDC CODE: 10237-675

Proprietary Name: Complete Care Whole Mouth Protection 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 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

Color(s):
WHITE (C48325)
Flavor(s):
MINT (C73404 - FRESH MINT)

NDC Code Structure

NDC 10237-675-09

Package Description: 1 TUBE in 1 CARTON > 25.5 g in 1 TUBE

NDC 10237-675-12

Package Description: 1 TUBE in 1 CARTON > 340 g in 1 TUBE

NDC 10237-675-60

Package Description: 1 TUBE in 1 CARTON > 170 g in 1 TUBE

NDC Product Information

Complete Care Whole Mouth Protection with NDC 10237-675 is a a human over the counter drug product labeled by Church & Dwight Co., Inc.. The generic name of Complete Care Whole Mouth Protection is sodium fluoride. 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.

Complete Care Whole Mouth Protection 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.

  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • WATER (UNII: 059QF0KO0R)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • SORBITOL (UNII: 506T60A25R)
  • GLYCERIN (UNII: PDC6A3C0OX)

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: Church & Dwight Co., Inc.
Labeler Code: 10237
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: 12-31-2021 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.

Complete Care Whole Mouth Protection Product Label Images

Complete Care Whole Mouth Protection 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

Sodium fluoride 0.24%(0.15% w/v fluoride ion)

Otc - Purpose

Anticavity toothpaste

Indications & Usage

Aids in the prevention of dental decay

Warnings

Warnings





Do not use





if irritation occurs and persists.

Otc - Do Not Use

Do not use if irritation occurs and persists.

Otc - Keep Out Of Reach Of Children

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

Directions

Directions do not swallow • supervise children as necessary until capable of using without supervision • rinse away toothpaste residue throughly after brushing
adults and children 2 years and olderbrush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physicianchildren under 6 yearsinstruct in good brushing and rinsing habits (to minimize swallowing)children under 2 yearsask a dentist or physician

Inactive Ingredient

Water, sodium bicarbonate, sorbitol, hydrated silica, glycerin, tetrasodium pyrophosphate, flavor, sodium lauryl sulfate, sodium lauroyl sarcosinate, poloxamer 407, sodium saccharin, xanthan gum, titanium dioxide

Otc - Questions

Questions or comments?Call
1-800-786-5135Mon.-Fri. 9am-5pm ET
or visit
www.myoralcare.com

* Please review the disclaimer below.