NDC 70000-0458 Sore Throat Relief Cherry Flavor

Phenol

NDC Product Code 70000-0458

NDC Product Information

Sore Throat Relief Cherry Flavor with NDC 70000-0458 is a a human over the counter drug product labeled by Cardinal Health (leader). The generic name of Sore Throat Relief Cherry Flavor is phenol. The product's dosage form is spray and is administered via oral form.

Labeler Name: Cardinal Health (leader)

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


Sore Throat Relief Cherry Flavor Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • PHENOL 1.4 g/100mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

Administration Route(s)

Additional informationCallout TooltipWhat are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Cardinal Health (leader)
Labeler Code: 70000
FDA Application Number: part356 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 02-12-2019 Additional informationCallout TooltipWhat 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: 12-31-2020 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Sore Throat Relief Cherry Flavor Product Label Images

Sore Throat Relief Cherry Flavor 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 Ingredient

Phenol 1.4%

Purpose

Oral Anesthetic/Analgesic

Uses

For the temporary relief of occasional minor irritation, pain, sore mouth and sore throat.

Warnings

Sore throat warning: Severe or persistent sore throat or sore throat that accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 6 years of age unless directed by a doctor.

When Using This Product,

Do not exceed recommended dose.

Stop Use And Ask A Doctor Or Dentist If

  • •sore mouth symptoms do not improve in 7 days •irritation, pain or redness persists or worsens •swelling, rash or fever develops

If Pregnant Or Breast-Feeding,

Ask a doctor before use.

Keep Out Of Reach Of Children.

In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

  • •Apply to affected area (one spray). Allow to remain in place for at least 15 seconds, then spit out.Adults and children 12 year of age and olderUse every 2 hours or as directed by a doctor or dentistChildren under 12 years of ageShould be supervised in use of this productChildren under 6 years of ageAsk a doctor or dentist

Other Information

  • •Store at room temperature •Check expiration date before using.

Inactive Ingredients

FD&C Red No. 40, flavor, glycerin, purified water, sucralose.

* Please review the disclaimer below.

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