NDC 44237-046 Novex Sore Throat Honey Lemon Flavor

Benzocaine And Menthol, Unspecified Form

NDC Product Code 44237-046

NDC CODE: 44237-046

Proprietary Name: Novex Sore Throat Honey Lemon Flavor 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 And Menthol, Unspecified Form 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.

NDC Code Structure

  • 44237 - Herbion Pakistan (pvt.) Ltd
    • 44237-046 - Novex Sore Throat Honey Lemon Flavor

NDC 44237-046-05

Package Description: 2 BLISTER PACK in 1 CARTON > 9 LOZENGE in 1 BLISTER PACK

NDC Product Information

Novex Sore Throat Honey Lemon Flavor with NDC 44237-046 is a a human over the counter drug product labeled by Herbion Pakistan (pvt.) Ltd. The generic name of Novex Sore Throat Honey Lemon Flavor is benzocaine and menthol, unspecified form. The product's dosage form is lozenge and is administered via oral form.

Labeler Name: Herbion Pakistan (pvt.) Ltd

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.

Novex Sore Throat Honey Lemon Flavor 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.

  • BENZOCAINE 15 mg/2.51
  • MENTHOL, UNSPECIFIED FORM 3.6 mg/2.51

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.

  • ISOMALT (UNII: S870P55O2W)
  • MALTITOL (UNII: D65DG142WK)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • CARAMEL (UNII: T9D99G2B1R)

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.
  • 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: Herbion Pakistan (pvt.) Ltd
Labeler Code: 44237
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: 04-03-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Novex Sore Throat Honey Lemon Flavor Product Label Images

Novex Sore Throat Honey Lemon 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

Otc - Active Ingredient

Drug FactsActive ingredients (in each lozenge)Benzocaine 15mgMenthol 3.6mg

Otc - Purpose

Purposes  Oral pain reliever Oral pain reliever

Indications & Usage

UsesFor the temporary relief of occasional■ sore throat ■ sore mouth ■ minor irritation ■ pain ■ pain associated with canker sores

Warnings

Methemoglobinemia warning:Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:■ pale, gray, or blue colored skin (cyanosis)■ headache■ rapid heart rate■ shortness of breath■ dizziness or lightheadedness■ fatigue or lack of energyAllergy 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.Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.

Otc - Ask Doctor

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

Otc - Do Not Use

Do not use■ for teething■ in children under 5 years of age

Otc - Keep Out Of Reach Of Children

Keep out of reach of childrenIn case of overdose, get medical help or contact a Poison Control Center right away.Do not exceed recommended dosage

Dosage & Administration

Directions■ adults and children 5 years of age and older: allow one lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or as directed by a doctor or dentist.■ children under 5 years of age: do not use

Other Safety Information

Other Information:■ store at 20-25°C (68-77°F)■ protect contents from humidity

Inactive Ingredient

Inactive Ingredients:Caramel, FD&C Yellow no. 6, Flavors, Isomalt, Maltitol, Sodium Bicarbonate, Sucralose

Otc - Questions

Questions?Call 1-888-(OK-HERBION) 654-3724, Monday through Friday 9am - 5pm EST

* Please review the disclaimer below.