NDC 63824-780 Cepacol Ultra Sore Throat

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
63824-780
Proprietary Name:
Cepacol Ultra Sore Throat
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Labeler Code:
63824
Start Marketing Date: [9]
05-03-2011
Listing Expiration Date: [11]
12-31-2021
Exclude Flag: [12]
I
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Product Details

What is NDC 63824-780?

The NDC code 63824-780 is assigned by the FDA to the product Cepacol Ultra Sore Throat which is product labeled by Rb Health (us) Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 63824-780-75 1 bottle in 1 carton / 22.2 ml in 1 bottle. 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 Cepacol Ultra Sore Throat?

Adults and children 6 years of age and older: spray into throat or onto affected area with only ONE spray per use. Allow to remain in place for at least 1 minute and then spit out. Use up to 4 times daily or as directed by a dentist or doctorchildren 6 to under 12 years of age should be supervised in the use of this productchildren under 6 years of age: do not use

Which are Cepacol Ultra Sore Throat UNII Codes?

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

Which are Cepacol Ultra Sore Throat 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:

What is the NDC to RxNorm Crosswalk for Cepacol Ultra Sore Throat?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1039073 - Cepacol Dual Relief 5 % / 33 % Mucosal Spray
  • RxCUI: 1039073 - benzocaine 50 MG/ML / glycerin 330 MG/ML Mucosal Spray [Cepacol Dual Relief]
  • RxCUI: 1039073 - Cepacol Dual Relief (benzocaine 5 % / glycerin 33 % ) Mucosal Spray
  • RxCUI: 1039073 - Cepacol Ultra (benzocaine 5 % / glycerin 33 % ) Mucosal Spray
  • RxCUI: 744790 - benzocaine 5 % / glycerin 33 % Mucosal Spray

* Please review the disclaimer below.

Product Footnotes

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

[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.

[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 ("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".