NDC 52642-017 Throat Relief Lozenges

NDC Product Code 52642-017

NDC CODE: 52642-017

Proprietary Name: Throat Relief Lozenges 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.

Product Characteristics

Color(s):
RED (C48326)
Shape: ROUND (C48348)
Size(s):
22 MM
Imprint(s):
B
Flavor(s):
CHERRY (C73375)

NDC Code Structure

  • 52642 - Bestco Inc.

NDC 52642-017-09

Package Description: 9 LOZENGE in 1 BLISTER PACK

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Throat Relief Lozenges with NDC 52642-017 is a product labeled by Bestco Inc.. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 824574.

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.

  • WATER (UNII: 059QF0KO0R)

Product Labeler Information

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

Labeler Name: Bestco Inc.
Labeler Code: 52642
Start Marketing Date: 07-30-2012 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: 12-31-2019 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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.

Throat Relief Lozenges Product Label Images

Throat Relief Lozenges 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

Active ingredients (in each lozenge)Benzocaine 15 mgMenthol 3.6 mg

Otc - Purpose

PurposeOral anestheticOral anesthetic

Indications & Usage

Uses temporarily relieves these symptoms:occasional minor irritation, pain, sore mouth and sore throat

Warnings

WarningsSore throat warning: severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a dentist or doctor right away. Do not use more than 2 days or give to children under 5 years of age unless directed by a doctor.Allergy alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics.

Otc - Stop Use

Stop use and ask doctor ifsore throat is severe or irritation, pain or redness persists or worsenssore mouth symptoms do not improve in 7 days

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdosage

In case of overdose, get medical help or conatct Poison Control Center right away.

Dosage & Administration

Directionsadults and children 5 years and older allow 1 lozenge to dissolve slowly in mouth. May be repeated every two hours as necessary or as directed by a doctor. children under 5 years, ask a doctor.

Other Safety Information

Other information store at room temperatureprotect from moisture

Inactive Ingredient

Inactive ingredients: Corn starch, FD&C Red #40, glucose syrup, glycerin, medium chain triglycerides, natural & artificial flavors, propylene glycol, soybean oil, sucrose and water.

Otc - Questions

Questions? Call 1-800-245-2898, Monday thorugh Friday, 9AM - 4PM EST

* Please review the disclaimer below.