NDC 55910-066 Mixed Berry Sore Throat And Cough Lozenge

Benzocaine

NDC Product Code 55910-066

NDC CODE: 55910-066

Proprietary Name: Mixed Berry Sore Throat And Cough Lozenge 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: Benzocaine 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):
RED (C48326 - PURPLISH RED)
Shape: ROUND (C48348)
Size(s):
17 MM
Imprint(s):
B
Score: 1
Flavor(s):
BERRY (C73365)

NDC Code Structure

  • 55910 - Dollar General Corporation
    • 55910-066 - Mixed Berry Sore Throat And Cough Lozenge

NDC 55910-066-18

Package Description: 18 LOZENGE in 1 BLISTER PACK

NDC Product Information

Mixed Berry Sore Throat And Cough Lozenge with NDC 55910-066 is a a human over the counter drug product labeled by Dollar General Corporation. The generic name of Mixed Berry Sore Throat And Cough Lozenge is benzocaine. The product's dosage form is lozenge and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1039251.

Dosage Form: Lozenge - A solid preparation containing one or more medicaments, usually in a flavored, sweetened base which is intended to dissolve or disintegrate slowly in the mouth. A lollipop is a lozenge on a stick.

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.

Mixed Berry Sore Throat And Cough Lozenge 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.

  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What 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

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

Labeler Name: Dollar General Corporation
Labeler Code: 55910
FDA Application Number: part356 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 05-13-2016 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: 12-31-2021 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.

Mixed Berry Sore Throat And Cough Lozenge 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 lezenge)Benzocaine 7.5 mgDextromethorphan hydrobromide 5 mg

Otc - Purpose

PurposeOral pain relieverCough suppressant

Indications & Usage

Uses temporarily relieves these symptoms:occasional minor mouth irritation, sore mouth and sore throatcough due to minor throat and bronchial irritation as may occur with a common cold

Warnings

WarningsSore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting contact a doctor promptly.Allergy alert: Do not use if you have a history of allergy to local anesthetics such as prociane, butacaine, benzocaine, or other "caine" anesthetics.

Drug Interactions

Do not use if you are now takin a prescription monoamineoxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Otc - Ask Doctor

Ask a doctor before use if you have:persistent or chronic cough such as occurs with smoking, asthma, or emphysemacough that occurs with too much phlegm (mucus)

Otc - Stop Use

Stop use and ask a doctor ifsore mouth symptoms do not improve in 7 daysirritation, pain, or redness persists or worsensswelling developscough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

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 contact Poison Control Center right away.

Dosage & Administration

Directionsadults and children 12 years and older - Allow 2 lozenges to dissolve slowly in mouth, one at a time; may be repeated every 4 hours, not to exceed 12 lozenges in 24 hours, or as directed by a doctorchildren 6 to 12 years of age - take 1 lozenge and allow to dissolve slowly in mouth; may be repeated every 4 hours, not to exceed 6 lozenges in 24 hours, or as directed by a doctorchildren under 6 years of age - do not use

Inactive Ingredient

Inactive ingredients: Acesulfame potassium, corn starch, corn syrup, glycerin, FD&C blue no. 1, FD&C red no. 40, natural and artificial flavors, medium chain triglycerides, propylene glycol, soybean oil, sucrose, and water.

Otc - Questions

Questions? Call 888-309-9030

* Please review the disclaimer below.