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  4. NDC Product Code: 10237-756 Orajel For Cold Sores Single Dose

NDC 10237-756 Orajel For Cold Sores Single Dose

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 10237-756?
  4. Orajel For Cold Sores Single Dose Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Get all the details for National Drug Code (NDC) 10237-756 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
10237-756
Proprietary Name:
Orajel For Cold Sores Single Dose
Product Type: [3]
Labeler Name: [5]
Church & Dwight Co., Inc.
Labeler Code:
10237
Product Label ID:
05efbe22-2fed-42e3-a181-65558805cb2a
FDA Application Number: [6]
part356
Marketing Category: [8]
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date: [9]
07-01-2012
End Marketing Date: [10]
09-30-2024
Listing Expiration Date: [11]
09-30-2024
Exclude Flag: [12]
D
Code Navigator:

Code Structure Chart

Product Details

What is NDC 10237-756?

The NDC code 10237-756 is assigned by the FDA to the product Orajel For Cold Sores Single Dose which is product labeled by Church & Dwight Co., Inc.. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 10237-756-03 2 vial, single-dose in 1 package / 1.2 ml in 1 vial, single-dose, 10237-756-04 4 vial, single-dose in 1 package / 2.4 ml in 1 vial, single-dose. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Orajel For Cold Sores Single Dose?

Directions• Slide-off to remove the protective blue paper cover and slide it on the other end-opposite the white applicator tip• Squeeze the vial firmly on the arrow shown on the blue paper cap until you hear it snap• Hold with the white applicator tip down to allow the medication to saturate the tip• To minimize pain during application gently touch the site of the cold sore with the saturated applicator tip. Once the area is numb, rub the site of the cold sore and the surrounding area. Rub firmly to allow the treatment to deeply penetrate the skin.• To treat most cold sores, multiple treatments may be required• Discard after use• For best results ensure that lip area is free of lip preparations, lotions, ointments, residual beverages, or cosmetics, including lipstickAdults and children over 2 years of age: Do not use this more than 3 times per dayChildren between 2 year and 12 years of age: Ask a doctor before use. Should be supervised in the use of this productChildren under 2 years of age: Do not use OTHER INFORMATIONStore at room temperatureThe ingredients in toothpaste, soft drinks, and some fruit juices can deactivate the active ingredient in Orajel Single Dose.For best results, avoid brushing your teeth with toothpaste or drinking soft drinks or fruit juices for one hour after applying the drug.Do not use if package is torn, cut or otherwise damaged

Which are Orajel For Cold Sores Single Dose UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Orajel For Cold Sores Single Dose Inactive Ingredients UNII Codes?

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. The UNII codes for the inactive ingredients in this product are:

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Product Footnotes

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

[6] 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.

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

[11] 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.

[12] 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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".